Cognitive PerformanceNCT05281146
Production of Fortified Biscuit With Chickpea and Crushed Peanut for Improving Cognitive Performance
A study testing Chickpeas and crushed peanuts fortified biscuit, Cognitive stimulation for the mothers and Cognitive stimulation for students in people with Cognitive Performance, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
It is well known that globally, school-based fortification and school feeding approaches have been applied to remedy nutritional deficiencies that impact health in the primary school age group. Aim of the study: to produce a fortified biscuit with chickpea and crushed peanut. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cognitive Performance
- What is being tested?
- Chickpeas and crushed peanuts fortified biscuit, Cognitive stimulation for the mothers and Cognitive stimulation for students
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Nov 2018to 5 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- apparently healthy prepubescent boys and girls in the primary schools with four grades.
- Children should not skip breakfast,
- the number of daily meals (at least 3 times per day),
- does not eat any school snack meal during the school day (other than the biscuits under the study for the fortified biscuits dependent group).
Who cannot join
- any mental disorder,
- chronic disease,
- visual or auditory impairment, Any malnourished child as detected by both the anthropometric measures and by the Nutritional Status Assessment questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Production of Fortified Biscuit With Chickpea and Crushed Peanut and Evaluating Its Effectiveness in Terms of Its Acceptability and Cognitive Performance: a Pilot Study Among Egyptian Primary School-aged Children
It is well known that globally, school-based fortification and school feeding approaches have been applied to remedy nutritional deficiencies that impact health in the primary school age group.
Aim of the study: to produce a fortified biscuit with chickpea and crushed peanut. To evaluate the effectiveness of the fortified biscuits intake for 4 months in terms of its acceptability and impact on cognitive performance for a sample of children aged 8-12 years attending rural primary schools in an Egyptian village. The fortified biscuits' effect on auditory attention, visual and working memory, and learning ability was evaluated.
Methodology: This study was an interventional study conducted in two stages: stage one was the production of nutritious biscuits that is based on chickpea flour and peanut in addition to whole wheat (extract 72 %), wheat germ, cinnamon, milk, and egg. All these constituents help in enhancing immunity, fighting viruses, maintaining regular and healthy bowel movement, regulating blood sugar and cholesterol levels, and more importantly improving the cognitive abilities of school-aged children. During stage two, eighty Children were randomly allocated in either chickpea and peanuts biscuits dependent group (40 children) or non-dependent group (40 children) to evaluate the impact of the fortified biscuits. All enrolled children and their mothers received 5 cognitive stimulation sessions over four months. The cognitive performance of primary school-aged children was assessed before and after the interventions by a battery of four verbal \& non-verbal intelligence psychological tests. These tests covered short-term and working memory, visual memory, and the ability for categorization, learning for speed of information processing, and auditory attention ability with rising levels of difficulty. These tests were: Digit Span, the figural memory tests, Coding and Auditory vigilance tests A and B respectively. Five items were used to evaluate the physical characteristics of the biscuits: color, odor, taste, consistency, and general acceptance.
Read the detailed description
Nutritional factors are one of the interacting factors to affect all developmental aspects among Egyptian children since birth. During the first two years of life, Egyptian studies put more emphasis on child nutrition and development with intensive efforts around breastfeeding because of being a critical period of rapid change. During this phase, studies were implemented to prepare children for subsequent developmental competency in their childhood by investigating the risk factors affecting the early cognitive development of Egyptian infants, and monitoring their cognitive performance. Later on in life, more emphasis was put on either studying factors behind malnutrition or providing educational and nutritional interventions to enhance growth and development.
To address the nutritional needs of school-aged children, global efforts have extensively focused on school-based fortification approaches for school feeding programs (SFPs). SFPs are linked to Goal number 2 (zero hunger) of the Sustainable Development Goals (SDG). The Ministry of Agriculture and Land Reclamation (MOLAR) in Egypt has directed SFP since 1998 to attract children in Egyptian rural areas to attend primary schools by providing them nutritious subsidized in-school meals as a contribution to breakfast consumption. The potential impact goal of targeting children through Food for Education programs (FFE) is to increase their educational achievement and subsequently improve their potential future efficiency and profit. This program includes governmental primary schools within all governorates of Egypt. The close link between nutritional deficiency and diminished cognitive performance and subsequently retarded educational accomplishment was the reason behind implementing nutritional feeding for Egyptian school-aged children to improve their health, cognitive performance, attention span, school attendance, and educational achievement.
Investments in nutrition and cognitive stimulation programs are thus the keys to optimizing child cognitive development and performance. From this perspective, our idea was generated - Relying on the consumption of biscuits that are based on natural ingredients (chickpeas \&, peanuts- for improving the cognitive function of children during the school days is much better than relying on drugs.
Both chickpeas and peanuts are types of legumes that are common in Egypt and the middle east. Egypt is a common source for chickpea production in the world where it is mostly consumed as whole seeds and several types of traditional food products. Both of them are overlooked as nutritious food although they have many health benefits as the more expensive nuts and must not be neglected.
These two beans although being nutritionally overachievers that deserve so much more, Yet, they're always moved down to the side-dish zone (e.g puréed of hummus). These two ingredients in addition to Wheat germ and Cinnamon could boost mental health improve mood, memory, cognitive stimulation, muscle control, and other nervous system and brain activities due to their vitamins, minerals, and chemical contents.
The objectives of the study:
to produce a fortified biscuit with chickpea and crushed peanut. To evaluate its effectiveness in terms of its acceptability and impact on cognitive performance for a sample of children aged 8-12 years attending rural primary schools in an Egyptian village after four months of daily intake of 3 biscuits per day for 4 months.
Specific aims To produce Chickpeas and Crushed peanut fortified biscuit To evaluate biscuit effect on short-term and working memory To evaluate biscuit effect on visual memory and the ability for categorization To evaluate biscuit effect on learning for speed of information processing, To evaluate biscuit effect on auditory attention ability with rising levels of difficulty.
Methodology:
Study design and Setting:
The study was a pilot community-based intervention that was conducted in El Othmanyia village of El Mahala district- Gharbyia governorate.
Phases of the study and tools:
This study was conducted in three phases that were done in a simultaneous way. The first phase included children recruitment and baseline assessment before intervention:
Assessment tools (Methods):
Anthropometric measurements of weight and height were carried out to exclude mal-nourished children. All measurements were made according to techniques described in the Anthropometric Standardization Reference Manual. Anthropometric measurements were taken during morning hours on empty stomach before having breakfast or a school meal, within a minimum of 8 hours after micturition and defecation, and after the morning exercises of spine stretching. All scores were calculated based on the WHO growth standards with the help of the Anthro-Program of PC.
Growth assessment according to WHO recommendations
- Weight (in kg): by a Seca Scale Balance
- Height (in cm): using Stadiometer
- BMI (weight/Height2 in meter): calculated Dietary assessment: Detailed nutritional and dietary assessment using Diet Quality index assessment questionnaire, Food frequency pattern, and 24 hours questionnaires.
Cognitive performance assessment: Cognitive performance was assessed before and after the intervention by a battery of psychological tests that covered verbal \& non-verbal intelligence, memory, learning, and attention. The children were individually tested by trained researchers.
These tests are:
- The Digit Span Test: The effect of the intake of the fortified biscuits with stimulation on short-term and working memory was tested by using the Digit Span Test: It is a subtest of the Revised Wechsler Intelligence Scale. The digit span memory task is a verbal measure of immediate memory and working memory maintenance and manipulation. Methodologically, digit span tasks have been proven to be both reliable and valid measures of working memory capacity. The Arabic version of the Revised Wechsler Intelligence Scale for children was used
- Coding test: It is also a subtest of the Revised Wechsler Intelligence Scale for children. The children had to substitute symbols for numbers as quickly as possible. The score represents the total number of correct symbols written during a fixed time.
- The auditory vigilance test: which measures the attention ability. It is a measure of the efficiency of identifying signal stimuli in the context of non-signal stimuli. The subjects were asked to pay attention while listening to many words from different categories like a key, ball, school, etc., and they were asked to give a sign, like raising their hands, when they hear certain words, chosen by the administrator. The scores of the test were calculated as total right and totally wrong.
- The figural memory test: is a measure of free recall of visual objects. The subjects were shown a group of different photos like animals, cars, plants, etc., and they were asked to mention as many photos as they can.
Intervention phase 80 children of those who fulfilled the inclusion and the exclusion criteria were allocated randomly to either one of two groups (every 40 children),
- The chickpea and crushed peanut biscuits dependent group received one daily pack of three fortified biscuits as snakes between breakfast and lunch on daily basis for four months.
- The chickpea and crushed peanut biscuits non-dependent group received nothing
- This supplement was accompanied by cognitive stimulation for both the two groups for the children and their parents (a monthly session with a total of 4 sessions for each)
Composition of the fortified biscuits:
The chickpeas and crushed peanuts fortified biscuit consisted of wheat flour (extract 72%), Chickpeas flour, crushed peanuts, wheat germ, Skimmed milk, corn oil, egg, sugar, Cinnamon, baking powder, salt, and vanilla. The first four constituents help in enhancing immunity, fighting viruses, maintaining regular and healthy bowel movement, regulating blood sugar and cholesterol levels, and more importantly improving the cognitive abilities of school-aged children.
Topics of stimulation sessions I. Sessions for mothers • Sessions for students
- 3. Post Intervention Evaluation Phase This phase included evaluation of the effect of consumption of the chickpea and crushed peanut biscuits on the improvement of the cognitive abilities
- Conditions
- Cognitive Performance
- Being tested
- Chickpeas and crushed peanuts fortified biscuit, Cognitive stimulation for the mothers, Cognitive stimulation for students
- Keywords
- chickpea, crushed peanut, Wheat germ, Cinnamon, short-term memory, working memory, visual memory, information processing, auditory attention ability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chickpeas and crushed peanuts fortified biscuitDietary supplement
This group received one daily pack of three fortified biscuits as snakes between breakfast and lunch on daily basis for four months. The chickpeas and crushed peanuts fortified biscuit consisted of wheat flour (extract 72%), Chickpea flour, crushed peanuts, wheat germ, Skimmed milk, corn oil, egg, sugar, Cinnamon, baking powder, salt, and vanilla.
Cognitive stimulation for the mothersOther
- Sessions for mothers
- Informing mothers about the most common causes of poor school achievement
- Clarification of mother's and family roles in improving student's cognitive abilities
- Defining cognitive functions needed for learning and school achievement
- Attention, perceptive reasoning, memory, problem solving, proper use of language
- Identifying sensory functions necessary for the growth of cognitive functions
- Explaining factors that assist in academic excellence
Cognitive stimulation for studentsOther
- Activities to improve focus and visual attention
- Activities to improve visual memory
- Activities to improve vigilance and auditory attention
- Explaining types of memory Causes of weak memory Factors helping in improving memory Nutritional elements improving memory
- Training on skills of problem-solving
| Study group | Role | What they receive |
|---|---|---|
| chickpea and peanuts biscuits dependent group | Active comparator | children aged 8- 12 years attending the village school. This group received one daily pack of three fortified biscuits as snakes between breakfast and lunch on daily basis for four months. Receives: Dietary Supplement: Chickpeas and crushed peanuts fortified biscuit; Other: Cognitive stimulation for the mothers; Other: Cognitive stimulation for students |
| The chickpea and crushed peanut biscuits non-dependent group | Active comparator | Matched age and sex children attending the same village school. This group did not receive the fortified biscuits but received their ordinary usual breakfasts or snacks for four months. Receives: Other: Cognitive stimulation for the mothers; Other: Cognitive stimulation for students |
What is being measured
The primary outcome is the main question the study is designed to answer.
Production of Chickpeas and Crushed peanut fortified biscuit
number of fortified biscuits that are based on chickpeas and crushed peanut produced to cover the sampled children on the base of 3 biscuits per day for 4 months to be given to the children to stimulate their cognitive abilities
Measured: three months after the initiation of the study
Mean change of scaled score of the Digit Span Test as a measure of short-term and working memory to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group
An increase in the mean scaled score of the Digit Span Test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on short-term and working memory. The unpaired t-test between the two means will be used to detect the differences between biscuits dependent and the non-dependent groups.
Measured: 4 months after the initiation of the intervention
Mean change of scaled score of the figural memory test as a measure of visual memory to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group
An Increase in the mean scaled score of the figural memory test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on visual memory. The unpaired t-test between the two means will be used to detect the differences between biscuits dependent and the non-dependent groups.
Measured: 4 months after the initiation of the intervention
Mean change of scaled score of auditory vigilance tests A and B Test as a measure of auditory attention ability with rising levels of difficulty to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group
An increase of the mean score of right responses and decrease of the mean score of wrong responses of Auditory vigilance tests A and B Test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on auditory attention. The unpaired t-test between the two means will be to detect the differences between biscuits dependent and the non-dependent groups
Measured: 4 months after the initiation of the intervention
Mean change of scaled score of the Coding test as a measure of improved visual-motor coordination, visual encoding, and speed of information processing to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group
An increase of the mean scaled score of the Coding test indicates an improvement of visual-motor coordination, visual encoding, and speed of information processing as a result of the intake of the fortified biscuits with the cognitive stimulation. The unpaired t-test between the two means will be to detect the differences between biscuits dependent and the non-dependent groups
Measured: 4 months after the initiation of the intervention
Mean change of scaled score of the Digit Span Test as a measure of short-term and working memory to detect the fortified biscuits' effect compared to before fortification
An increase in the mean scaled score of the Digit Span Test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on short-term and working memory. The paired t-test was used to detect the differences between (before and after the intervention)
Measured: 4 months after the initiation of the intervention
Mean change of scaled score of the figural memory test as a measure of visual memory to detect the fortified biscuits' effect compared to before fortification
An Increase in the mean scaled score of the figural memory test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on visual memory. The paired t-test was used to detect the differences between (before and after the intervention)
Measured: 4 months after the initiation of the intervention
Mean change of scaled score of auditory vigilance tests A and B Test as a measure of auditory attention ability with rising levels of difficulty to detect the fortified biscuits' effect compared to before fortification
An increase in the mean score of right responses and decrease in the mean score of wrong responses of Auditory vigilance tests A and B Test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on auditory attention The paired t-test was used to detect the differences between (before and after the intervention)
Measured: 4 months after the initiation of the intervention
Mean change of scaled score of the Coding test as a measure of improved visual-motor coordination, visual encoding, and speed of information processing to detect the fortified biscuits' effect compared to before fortification
An increase in the mean scaled score of the Coding test indicates an improvement of visual-motor coordination, visual encoding, and speed of information processing as a result of the intake of the fortified biscuits with the cognitive stimulation. The paired t-test was used to detect the differences between (before and after the intervention)
Measured: 4 months after the initiation of the intervention
Secondary outcomes (4)
Mean change of scaled score of the Digit Span Test as a measure of short-term and working memory to detect the cognitive stimulation effect among the fortified biscuits non-dependent group
An increase in the mean scaled score of the Digit Span Test as a result of cognitive stimulation only indicated a positive effect on short-term and working memory. The paired t-test was used to detect the differences between (before and after the intervention)
Measured: 4 months after the initiation of the intervention
Mean change of scaled score of the figural memory test as a measure of visual memory to detect the cognitive stimulation effect among the fortified biscuits non-dependent group
An Increase in the mean scaled score of the figural memory test as a result of cognitive stimulation only indicated a positive effect on visual memory. The paired t-test was used to detect the differences between (before and after the intervention)
Measured: 4 months after the initiation of the intervention
Change of mean scaled score of Cognitive stimulation ability to improve auditory attention ability with rising levels of difficulty to detect the cognitive stimulation effect among the fortified biscuits non-dependent group
An increase in the mean score of right responses and decrease in the mean score of wrong responses of Auditory vigilance tests A and B Test as a result of cognitive stimulation only indicated a positive effect on auditory attention The paired t-test was used to detect the differences between (before and after the intervention)
Measured: 4 months after the initiation of the intervention
Change of mean scaled score of Cognitive stimulation ability to improve learning for speed of information processing to detect the cognitive stimulation effect among the fortified biscuits non-dependent group
An increase in the mean scaled score of the Coding test indicates an improvement of visual-motor coordination, visual encoding, and speed of information processing as a result of cognitive stimulation only. The paired t-test was used to detect the differences between (before and after the intervention)
Measured: 4 months after the initiation of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start26 Nov 2018
- Primary completion5 Mar 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Cognitive PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Theoretically, fortified biscuits based on chickpea flour and crushed peanuts in addition to wheat germ, and Cinnamon help in enhancing immunity, fighting viruses, maintaining regular and healthy bowel movement, regulating blood sugar and cholesterol levels, and more importantly improving cognitive abilities of school aged children. It is important to practically evaluate the effectiveness of the fortified biscuits intake for 4 months in terms of its acceptability and impact on cognitive performance for a sample of children aged 8-12 years attending rural primary schools in an Egyptian village. Eighty Children were randomly allocated in either chickpea and peanuts biscuits dependent group (40 children) or the non-dependent group (40 children).
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.Dr. Ammal Mokhtar Metwally, National Research Centre, Egypt
- Investigators
- Ammal M Metwally, PhD (MD), Principal investigator, National Research Centre of Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281146
- Sponsor's protocol ID
- 20180926
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication will be shared
Publications
El-Din EMS, Elabd MA, Nassar MS, Metwally AM, Abdellatif GA, Rabah TM, Shalaan A, Shaaban SY, Kandeel W, Etreby LAE, Al-Tohamy M. The Interaction of Social, Physical and Nutritive Factors in Triggering Early Developmental Language Delay in a Sample of Egyptian Children. Open Access Maced J Med Sci. 2019 Sep 12;7(17):2767-2774. doi: 10.3889/oamjms.2019.642. eCollection 2019 Sep 15.
PubMed 31844434Kandeel WA, Rabah TM, Zeid DA, El-Din EMS, Metwally AM, Shaalan A, El Etreby LA, Shaaban SY. Determinants of Exclusive Breastfeeding in a Sample of Egyptian Infants. Open Access Maced J Med Sci. 2018 Oct 2;6(10):1818-1823. doi: 10.3889/oamjms.2018.359. eCollection 2018 Oct 25.
PubMed 30455755El Din EMS, Rabah TM, Metwally AM, Nassar MS, Elabd MA, Shalaan A, Kandeel W, El Etreby LA, Shaaban SY. Potential Risk Factors of Developmental Cognitive Delay in the First Two Years of Life. Open Access Maced J Med Sci. 2019 Jun 30;7(12):2024-2030. doi: 10.3889/oamjms.2019.566. eCollection 2019 Jun 30.
PubMed 31406549Metwally AM, Salah El-Din EM, Shehata MA, Shaalan A, El Etreby LA, Kandeel WA, Shaaban SY, Rabah TM. Early Life Predictors of Socio-Emotional Development in a Sample of Egyptian Infants. PLoS One. 2016 Jul 5;11(7):e0158086. doi: 10.1371/journal.pone.0158086. eCollection 2016.
PubMed 27379907Salah El-Din EM, Monir ZM, Shehata MA, Abouelnaga MW, Abushady MM, Youssef MM, Megahed HS, Salem SME, Metwally AM. A comparison of the performance of normal middle social class Egyptian infants and toddlers with the reference norms of the Bayley Scales -third edition (Bayley III): A pilot study. PLoS One. 2021 Dec 2;16(12):e0260138. doi: 10.1371/journal.pone.0260138. eCollection 2021.
PubMed 34855785Metwally AM, Shaaban FA, Mahmoud WS, Salah EM, El-Sonbaty MM, Hussien HA, Hamid NA, El Etreby LA, Hassanin A, Monir Z. Vulnerability and Weaknesses of Eating Habits of Overweight School Children as an Entry Risk for COVID-19. Open Access Maced J Med Sci [Internet]. 2020Aug.30 [cited 2020Oct.18];8(T1):158-66. DOI: https://doi.org/10.3889/oamjms.2020.5049 Available from: https://www.id-press.eu/mjms/article/view/5049
Metwally AM, El-Sonbaty M, El Etreby LA, El-Din EMS, Hamid NA, Hussien HA, Hassanin A, Monir ZM. Stunting and its Determinants among Governmental Primary School Children in Egypt: A School-based Cross-sectional Study. Open Access Maced J Med Sci [Internet]. 2020 Sep.15 ;8(B):650-7. DOI: https://doi.org/10.3889/oamjms.2020.4757
Metwally AM, El-Sonbaty MM, El Etreby LA, Salah El-Din EM, Abdel Hamid N, Hussien HA, Hassanin AM, Monir ZM. Impact of National Egyptian school feeding program on growth, development, and school achievement of school children. World J Pediatr. 2020 Aug;16(4):393-400. doi: 10.1007/s12519-020-00342-8. Epub 2020 Feb 13.
PubMed 32056148Salah EM, Khalifa AG, Metwally AM, Abdel Hamid N, Hussien HA and Moneer ZM: "The Impact Of School Snacks On Cognitive Function Of Primary School Children In Egypt" Journal of Applied Sciences Research, 8(12): 5639-5650, 2012, ISSN 1819-544X
Bundy D, Burbano C, Grosh M, Gelli A, Jukes M, Drake L. Rethinking school feeding: social safety nets, child development, and the education sector. Washington, D.C. (US): The World Food Programme and the World Bank. 2009.
WFP (World Food Programme). How school meals contribute to the sustainable development goals. 2017. https://documents.wfp.org/stellent/groups/public/documents/communications/wfp290718.pdf. Accessed 29 Aug 2019.
Chavan JK, Kadam SS, Salunkhe DK. Biochemistry and technology of chickpea (Cicer arietinum L.) seeds. Crit Rev Food Sci Nutr. 1986;25(2):107-58. doi: 10.1080/10408398709527449.
PubMed 3549160Marinangeli CPF, Curran J, Barr SI, Slavin J, Puri S, Swaminathan S, Tapsell L, Patterson CA. Enhancing nutrition with pulses: defining a recommended serving size for adults. Nutr Rev. 2017 Dec 1;75(12):990-1006. doi: 10.1093/nutrit/nux058.
PubMed 29202192Arya SS, Salve AR, Chauhan S. Peanuts as functional food: a review. J Food Sci Technol. 2016 Jan;53(1):31-41. doi: 10.1007/s13197-015-2007-9. Epub 2015 Sep 19.
PubMed 26787930Moreira-Rosario A, Pinheiro H, Calhau C, Azevedo LF. Can wheat germ have a beneficial effect on human health? A study protocol for a randomised crossover controlled trial to evaluate its health effects. BMJ Open. 2016 Nov 10;6(11):e013098. doi: 10.1136/bmjopen-2016-013098.
PubMed 28157671
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Production of Fortified Biscuit With Chickpea and Crushed Peanut and Evaluating Its Effectiveness in Terms of Its Acceptability and Cognitive Performance: a Pilot Study Among Egyptian Primary School-aged Children
- ClinicalTrials.gov ID
- NCT05281146
- Acronym / sponsor ID
- 20180926
- Conditions
- Cognitive Performance
- Keywords
- chickpea, crushed peanut, Wheat germ, Cinnamon, short-term memory, working memory, visual memory, information processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is well known that globally, school-based fortification and school feeding approaches have been applied to remedy nutritional deficiencies that impact health in the primary school age group.
Aim of the study: to produce a fortified biscuit with chickpea and crushed peanut. To evaluate the effectiveness of the fortified biscuits intake for 4 months in terms of its acceptability and impact on cognitive performance for a sample of children aged 8-12 years attending rural primary schools in an Egyptian village. The fortified biscuits' effect on auditory attention, visual and working memory, and learning ability was evaluated.
Methodology: This study was an interventional study conducted in two stages: stage one was the production of nutritious biscuits that is based on chickpea flour and peanut in addition to whole wheat (extract 72 %), wheat germ, cinnamon, milk, and egg. All these constituents help in enhancing immunity, fighting viruses, maintaining regular and healthy bowel movement, regulating blood sugar and cholesterol levels, and more importantly improving the cognitive abilities of school-aged children. During stage two, eighty Children were randomly allocated in either chickpea and peanuts biscuits dependent group (40 children) or non-dependent group (40 children) to evaluate the impact of the fortified biscuits. All enrolled children and their mothers received 5 cognitive stimulation sessions over four months. The cognitive performance of primary school-aged children was assessed before and after the interventions by a battery of four verbal \& non-verbal intelligence psychological tests. These tests covered short-term and working memory, visual memory, and the ability for categorization, learning for speed of information processing, and auditory attention ability with rising levels of difficulty. These tests were: Digit Span, the figural memory tests, Coding and Auditory vigilance tests A and B respectively. Five items were used to evaluate the physical characteristics of the biscuits: color, odor, taste, consistency, and general acceptance.
Detailed description
Nutritional factors are one of the interacting factors to affect all developmental aspects among Egyptian children since birth. During the first two years of life, Egyptian studies put more emphasis on child nutrition and development with intensive efforts around breastfeeding because of being a critical period of rapid change. During this phase, studies were implemented to prepare children for subsequent developmental competency in their childhood by investigating the risk factors affecting the early cognitive development of Egyptian infants, and monitoring their cognitive performance. Later on in life, more emphasis was put on either studying factors behind malnutrition or providing educational and nutritional interventions to enhance growth and development.
To address the nutritional needs of school-aged children, global efforts have extensively focused on school-based fortification approaches for school feeding programs (SFPs). SFPs are linked to Goal number 2 (zero hunger) of the Sustainable Development Goals (SDG). The Ministry of Agriculture and Land Reclamation (MOLAR) in Egypt has directed SFP since 1998 to attract children in Egyptian rural areas to attend primary schools by providing them nutritious subsidized in-school meals as a contribution to breakfast consumption. The potential impact goal of targeting children through Food for Education programs (FFE) is to increase their educational achievement and subsequently improve their potential future efficiency and profit. This program includes governmental primary schools within all governorates of Egypt. The close link between nutritional deficiency and diminished cognitive performance and subsequently retarded educational accomplishment was the reason behind implementing nutritional feeding for Egyptian school-aged children to improve their health, cognitive performance, attention span, school attendance, and educational achievement.
Investments in nutrition and cognitive stimulation programs are thus the keys to optimizing child cognitive development and performance. From this perspective, our idea was generated - Relying on the consumption of biscuits that are based on natural ingredients (chickpeas \&, peanuts- for improving the cognitive function of children during the school days is much better than relying on drugs.
Both chickpeas and peanuts are types of legumes that are common in Egypt and the middle east. Egypt is a common source for chickpea production in the world where it is mostly consumed as whole seeds and several types of traditional food products. Both of them are overlooked as nutritious food although they have many health benefits as the more expensive nuts and must not be neglected.
These two beans although being nutritionally overachievers that deserve so much more, Yet, they're always moved down to the side-dish zone (e.g puréed of hummus). These two ingredients in addition to Wheat germ and Cinnamon could boost mental health improve mood, memory, cognitive stimulation, muscle control, and other nervous system and brain activities due to their vitamins, minerals, and chemical contents.
The objectives of the study:
to produce a fortified biscuit with chickpea and crushed peanut. To evaluate its effectiveness in terms of its acceptability and impact on cognitive performance for a sample of children aged 8-12 years attending rural primary schools in an Egyptian village after four months of daily intake of 3 biscuits per day for 4 months.
Specific aims To produce Chickpeas and Crushed peanut fortified biscuit To evaluate biscuit effect on short-term and working memory To evaluate biscuit effect on visual memory and the ability for categorization To evaluate biscuit effect on learning for speed of information processing, To evaluate biscuit effect on auditory attention ability with rising levels of difficulty.
Methodology:
Study design and Setting:
The study was a pilot community-based intervention that was conducted in El Othmanyia village of El Mahala district- Gharbyia governorate.
Phases of the study and tools:
This study was conducted in three phases that were done in a simultaneous way. The first phase included children recruitment and baseline assessment before intervention:
Assessment tools (Methods):
Anthropometric measurements of weight and height were carried out to exclude mal-nourished children. All measurements were made according to techniques described in the Anthropometric Standardization Reference Manual. Anthropometric measurements were taken during morning hours on empty stomach before having breakfast or a school meal, within a minimum of 8 hours after micturition and defecation, and after the morning exercises of spine stretching. All scores were calculated based on the WHO growth standards with the help of the Anthro-Program of PC.
Growth assessment according to WHO recommendations
- Weight (in kg): by a Seca Scale Balance
- Height (in cm): using Stadiometer
- BMI (weight/Height2 in meter): calculated Dietary assessment: Detailed nutritional and dietary assessment using Diet Quality index assessment questionnaire, Food frequency pattern, and 24 hours questionnaires.
Cognitive performance assessment: Cognitive performance was assessed before and after the intervention by a battery of psychological tests that covered verbal \& non-verbal intelligence, memory, learning, and attention. The children were individually tested by trained researchers.
These tests are:
- The Digit Span Test: The effect of the intake of the fortified biscuits with stimulation on short-term and working memory was tested by using the Digit Span Test: It is a subtest of the Revised Wechsler Intelligence Scale. The digit span memory task is a verbal measure of immediate memory and working memory maintenance and manipulation. Methodologically, digit span tasks have been proven to be both reliable and valid measures of working memory capacity. The Arabic version of the Revised Wechsler Intelligence Scale for children was used
- Coding test: It is also a subtest of the Revised Wechsler Intelligence Scale for children. The children had to substitute symbols for numbers as quickly as possible. The score represents the total number of correct symbols written during a fixed time.
- The auditory vigilance test: which measures the attention ability. It is a measure of the efficiency of identifying signal stimuli in the context of non-signal stimuli. The subjects were asked to pay attention while listening to many words from different categories like a key, ball, school, etc., and they were asked to give a sign, like raising their hands, when they hear certain words, chosen by the administrator. The scores of the test were calculated as total right and totally wrong.
- The figural memory test: is a measure of free recall of visual objects. The subjects were shown a group of different photos like animals, cars, plants, etc., and they were asked to mention as many photos as they can.
Intervention phase 80 children of those who fulfilled the inclusion and the exclusion criteria were allocated randomly to either one of two groups (every 40 children),
- The chickpea and crushed peanut biscuits dependent group received one daily pack of three fortified biscuits as snakes between breakfast and lunch on daily basis for four months.
- The chickpea and crushed peanut biscuits non-dependent group received nothing
- This supplement was accompanied by cognitive stimulation for both the two groups for the children and their parents (a monthly session with a total of 4 sessions for each)
Composition of the fortified biscuits:
The chickpeas and crushed peanuts fortified biscuit consisted of wheat flour (extract 72%), Chickpeas flour, crushed peanuts, wheat germ, Skimmed milk, corn oil, egg, sugar, Cinnamon, baking powder, salt, and vanilla. The first four constituents help in enhancing immunity, fighting viruses, maintaining regular and healthy bowel movement, regulating blood sugar and cholesterol levels, and more importantly improving the cognitive abilities of school-aged children.
Topics of stimulation sessions I. Sessions for mothers • Sessions for students
- 3. Post Intervention Evaluation Phase This phase included evaluation of the effect of consumption of the chickpea and crushed peanut biscuits on the improvement of the cognitive abilities
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Theoretically, fortified biscuits based on chickpea flour and crushed peanuts in addition to wheat germ, and Cinnamon help in enhancing immunity, fighting viruses, maintaining regular and healthy bowel movement, regulating blood sugar and cholesterol levels, and more importantly improving cognitive abilities of school aged children. It is important to practically evaluate the effectiveness of the fortified biscuits intake for 4 months in terms of its acceptability and impact on cognitive performance for a sample of children aged 8-12 years attending rural primary schools in an Egyptian village. Eighty Children were randomly allocated in either chickpea and peanuts biscuits dependent group (40 children) or the non-dependent group (40 children).
| Arm | Type | Receives |
|---|---|---|
| chickpea and peanuts biscuits dependent group | Active comparator | Dietary Supplement: Chickpeas and crushed peanuts fortified biscuit, Other: Cognitive stimulation for the mothers, Other: Cognitive stimulation for studentschildren aged 8- 12 years attending the village school. This group received one daily pack of three fortified biscuits as snakes between breakfast and lunch on daily basis for four months. |
| The chickpea and crushed peanut biscuits non-dependent group | Active comparator | Other: Cognitive stimulation for the mothers, Other: Cognitive stimulation for studentsMatched age and sex children attending the same village school. This group did not receive the fortified biscuits but received their ordinary usual breakfasts or snacks for four months. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- apparently healthy prepubescent boys and girls in the primary schools with four grades.
- Children should not skip breakfast,
- the number of daily meals (at least 3 times per day),
- does not eat any school snack meal during the school day (other than the biscuits under the study for the fortified biscuits dependent group).
Key exclusion criteria (3 listed)
- any mental disorder,
- chronic disease,
- visual or auditory impairment, Any malnourished child as detected by both the anthropometric measures and by the Nutritional Status Assessment questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chickpeas and crushed peanuts fortified biscuitThis group received one daily pack of three fortified biscuits as snakes between breakfast and lunch on daily basis for four months. The chickpeas and crushed peanuts fortified biscuit consisted of wheat flour (extract 72%), Chickpea flour, crushed peanuts, wheat germ, Skimmed milk, corn oil, egg, sugar, Cinnamon, baking powder, salt, and vanilla. | Dietary supplement | chickpea and peanuts biscuits dependent group |
| Cognitive stimulation for the mothersI. Sessions for mothers * Informing mothers about the most common causes of poor school achievement * Clarification of mother's and family roles in improving student's cognitive abilities * Defining cognitive functions needed for learning and school achievement o Attention, perceptive reasoning, memory, problem solving, proper use of language * Identifying sensory functions necessary for the growth of cognitive functions * Explaining factors that assist in academic excellence | Other | The chickpea and crushed peanut biscuits non-dependent group, chickpea and peanuts biscuits dependent group |
| Cognitive stimulation for students* Activities to improve focus and visual attention * Activities to improve visual memory * Activities to improve vigilance and auditory attention * Explaining types of memory Causes of weak memory Factors helping in improving memory Nutritional elements improving memory * Training on skills of problem-solving | Other | The chickpea and crushed peanut biscuits non-dependent group, chickpea and peanuts biscuits dependent group |
Primary outcome
Production of Chickpeas and Crushed peanut fortified biscuit
Time frame: three months after the initiation of the study
number of fortified biscuits that are based on chickpeas and crushed peanut produced to cover the sampled children on the base of 3 biscuits per day for 4 months to be given to the children to stimulate their cognitive abilities
Mean change of scaled score of the Digit Span Test as a measure of short-term and working memory to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group
Time frame: 4 months after the initiation of the intervention
An increase in the mean scaled score of the Digit Span Test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on short-term and working memory. The unpaired t-test between the two means will be used to detect the differences between biscuits dependent and the non-dependent groups.
Mean change of scaled score of the figural memory test as a measure of visual memory to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group
Time frame: 4 months after the initiation of the intervention
An Increase in the mean scaled score of the figural memory test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on visual memory. The unpaired t-test between the two means will be used to detect the differences between biscuits dependent and the non-dependent groups.
Mean change of scaled score of auditory vigilance tests A and B Test as a measure of auditory attention ability with rising levels of difficulty to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group
Time frame: 4 months after the initiation of the intervention
An increase of the mean score of right responses and decrease of the mean score of wrong responses of Auditory vigilance tests A and B Test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on auditory attention. The unpaired t-test between the two means will be to detect the differences between biscuits dependent and the non-dependent groups
Mean change of scaled score of the Coding test as a measure of improved visual-motor coordination, visual encoding, and speed of information processing to detect the fortified biscuits' effect compared to the fortified biscuits non-dependent group
Time frame: 4 months after the initiation of the intervention
An increase of the mean scaled score of the Coding test indicates an improvement of visual-motor coordination, visual encoding, and speed of information processing as a result of the intake of the fortified biscuits with the cognitive stimulation. The unpaired t-test between the two means will be to detect the differences between biscuits dependent and the non-dependent groups
Mean change of scaled score of the Digit Span Test as a measure of short-term and working memory to detect the fortified biscuits' effect compared to before fortification
Time frame: 4 months after the initiation of the intervention
An increase in the mean scaled score of the Digit Span Test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on short-term and working memory. The paired t-test was used to detect the differences between (before and after the intervention)
Mean change of scaled score of the figural memory test as a measure of visual memory to detect the fortified biscuits' effect compared to before fortification
Time frame: 4 months after the initiation of the intervention
An Increase in the mean scaled score of the figural memory test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on visual memory. The paired t-test was used to detect the differences between (before and after the intervention)
Mean change of scaled score of auditory vigilance tests A and B Test as a measure of auditory attention ability with rising levels of difficulty to detect the fortified biscuits' effect compared to before fortification
Time frame: 4 months after the initiation of the intervention
An increase in the mean score of right responses and decrease in the mean score of wrong responses of Auditory vigilance tests A and B Test as a result of the intake of the fortified biscuits with the cognitive stimulation indicated a positive effect on auditory attention The paired t-test was used to detect the differences between (before and after the intervention)
Mean change of scaled score of the Coding test as a measure of improved visual-motor coordination, visual encoding, and speed of information processing to detect the fortified biscuits' effect compared to before fortification
Time frame: 4 months after the initiation of the intervention
An increase in the mean scaled score of the Coding test indicates an improvement of visual-motor coordination, visual encoding, and speed of information processing as a result of the intake of the fortified biscuits with the cognitive stimulation. The paired t-test was used to detect the differences between (before and after the intervention)
4 secondary outcomes
Mean change of scaled score of the Digit Span Test as a measure of short-term and working memory to detect the cognitive stimulation effect among the fortified biscuits non-dependent group
Time frame: 4 months after the initiation of the intervention
Mean change of scaled score of the figural memory test as a measure of visual memory to detect the cognitive stimulation effect among the fortified biscuits non-dependent group
Time frame: 4 months after the initiation of the intervention
Change of mean scaled score of Cognitive stimulation ability to improve auditory attention ability with rising levels of difficulty to detect the cognitive stimulation effect among the fortified biscuits non-dependent group
Time frame: 4 months after the initiation of the intervention
Change of mean scaled score of Cognitive stimulation ability to improve learning for speed of information processing to detect the cognitive stimulation effect among the fortified biscuits non-dependent group
Time frame: 4 months after the initiation of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 31844434El-Din EMS, Elabd MA, Nassar MS, Metwally AM, Abdellatif GA, Rabah TM, Shalaan A, Shaaban SY, Kandeel W, Etreby LAE, Al-Tohamy M. The Interaction of Social, Physical and Nutritive Factors in Triggering Early Developmental Language Delay in a Sample of Egyptian Children. Open Access Maced J Med Sci. 2019 Sep 12;7(17):2767-2774. doi: 10.3889/oamjms.2019.642. eCollection 2019 Sep 15.
- Background: PubMed 30455755Kandeel WA, Rabah TM, Zeid DA, El-Din EMS, Metwally AM, Shaalan A, El Etreby LA, Shaaban SY. Determinants of Exclusive Breastfeeding in a Sample of Egyptian Infants. Open Access Maced J Med Sci. 2018 Oct 2;6(10):1818-1823. doi: 10.3889/oamjms.2018.359. eCollection 2018 Oct 25.
- Background: PubMed 31406549El Din EMS, Rabah TM, Metwally AM, Nassar MS, Elabd MA, Shalaan A, Kandeel W, El Etreby LA, Shaaban SY. Potential Risk Factors of Developmental Cognitive Delay in the First Two Years of Life. Open Access Maced J Med Sci. 2019 Jun 30;7(12):2024-2030. doi: 10.3889/oamjms.2019.566. eCollection 2019 Jun 30.
- Background: PubMed 27379907Metwally AM, Salah El-Din EM, Shehata MA, Shaalan A, El Etreby LA, Kandeel WA, Shaaban SY, Rabah TM. Early Life Predictors of Socio-Emotional Development in a Sample of Egyptian Infants. PLoS One. 2016 Jul 5;11(7):e0158086. doi: 10.1371/journal.pone.0158086. eCollection 2016.
- Background: PubMed 34855785Salah El-Din EM, Monir ZM, Shehata MA, Abouelnaga MW, Abushady MM, Youssef MM, Megahed HS, Salem SME, Metwally AM. A comparison of the performance of normal middle social class Egyptian infants and toddlers with the reference norms of the Bayley Scales -third edition (Bayley III): A pilot study. PLoS One. 2021 Dec 2;16(12):e0260138. doi: 10.1371/journal.pone.0260138. eCollection 2021.
- BackgroundMetwally AM, Shaaban FA, Mahmoud WS, Salah EM, El-Sonbaty MM, Hussien HA, Hamid NA, El Etreby LA, Hassanin A, Monir Z. Vulnerability and Weaknesses of Eating Habits of Overweight School Children as an Entry Risk for COVID-19. Open Access Maced J Med Sci [Internet]. 2020Aug.30 [cited 2020Oct.18];8(T1):158-66. DOI: https://doi.org/10.3889/oamjms.2020.5049 Available from: https://www.id-press.eu/mjms/article/view/5049
- BackgroundMetwally AM, El-Sonbaty M, El Etreby LA, El-Din EMS, Hamid NA, Hussien HA, Hassanin A, Monir ZM. Stunting and its Determinants among Governmental Primary School Children in Egypt: A School-based Cross-sectional Study. Open Access Maced J Med Sci [Internet]. 2020 Sep.15 ;8(B):650-7. DOI: https://doi.org/10.3889/oamjms.2020.4757
- Background: PubMed 32056148Metwally AM, El-Sonbaty MM, El Etreby LA, Salah El-Din EM, Abdel Hamid N, Hussien HA, Hassanin AM, Monir ZM. Impact of National Egyptian school feeding program on growth, development, and school achievement of school children. World J Pediatr. 2020 Aug;16(4):393-400. doi: 10.1007/s12519-020-00342-8. Epub 2020 Feb 13.
- BackgroundSalah EM, Khalifa AG, Metwally AM, Abdel Hamid N, Hussien HA and Moneer ZM: "The Impact Of School Snacks On Cognitive Function Of Primary School Children In Egypt" Journal of Applied Sciences Research, 8(12): 5639-5650, 2012, ISSN 1819-544X
- BackgroundBundy D, Burbano C, Grosh M, Gelli A, Jukes M, Drake L. Rethinking school feeding: social safety nets, child development, and the education sector. Washington, D.C. (US): The World Food Programme and the World Bank. 2009.
- BackgroundWFP (World Food Programme). How school meals contribute to the sustainable development goals. 2017. https://documents.wfp.org/stellent/groups/public/documents/communications/wfp290718.pdf. Accessed 29 Aug 2019.
- Background: PubMed 3549160Chavan JK, Kadam SS, Salunkhe DK. Biochemistry and technology of chickpea (Cicer arietinum L.) seeds. Crit Rev Food Sci Nutr. 1986;25(2):107-58. doi: 10.1080/10408398709527449.
- WHO, AnthroPlus for personal computers. Manual Software for assessing growth of the world's children and adolescents 2009. GenevaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ammal M Metwally, PhD (MD) principal investigator
National Research Centre of Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chickpeas and crushed peanuts fortified biscuit, Cognitive stimulation for the mothers and Cognitive stimulation for students in people with Cognitive Performance, run by National Research Centre, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Production of Chickpeas and Crushed peanut fortified biscuit (time frame: three months after the initiation of the study). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05281146, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.