Malnutrition (Calorie)CFC-MALNCT07504133
Composite Flour Cookies for Improving Nutrition in Malnourished Children
A study testing Composite Flour Cookies in people with Malnutrition (Calorie) and Protein-energy Malnutrition, run by Mairaj Noor at 1 site in Pakistan.
Trial summary
Malnutrition is a major public health concern among children in developing countries, leading to impaired growth and increased risk of morbidity. This study evaluated the effectiveness of nutrient-dense composite flour cookies as a dietary intervention to improve the nutritional status of malnourished children. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Malnutrition (Calorie), Protein-energy Malnutrition
- What is being tested?
- Composite Flour Cookies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 31 Jul 2024
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3-10 years diagnosed with malnutrition .
- Children willing to participate in the study.
- Participants whose parents or guardians provided informed consent.
- Children attending the selected hospital for nutritional assessment.
Who cannot join
- Children with severe chronic illnesses or metabolic disorders.
- Children with food allergies to ingredients used in the composite cookies (wheat, soy, chickpea, peanut).
- Children receiving other nutritional supplements during the study period.
- Children with severe acute medical conditions requiring hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Composite Flour-Enriched Cookies on Clinical Outcomes of Malnourished Children: A Randomized Controlled Trial
Malnutrition is a major public health concern among children in developing countries, leading to impaired growth and increased risk of morbidity. This study evaluated the effectiveness of nutrient-dense composite flour cookies as a dietary intervention to improve the nutritional status of malnourished children.
Composite cookies were developed using soy, chickpea, and peanut, and were subjected to nutritional and quality analysis including proximate composition and other physicochemical assessments prior to intervention. A randomized controlled trial was conducted among 60 malnourished children aged 3 to 10 years, divided into intervention and control groups.
Read more
The intervention group received the composite cookies along with their regular diet, while the control group continued with their usual diet. Anthropometric indicators including weight, body mass index (BMI), and mid-upper arm circumference (MUAC), as well as biochemical parameters such as hemoglobin and serum albumin, were assessed at baseline and after a 3-month intervention period.
The study aimed to determine whether supplementation with nutrient-rich composite cookies could significantly improve growth and nutritional outcomes in malnourished children.
Read the detailed description
This randomized controlled trial was conducted to evaluate the impact of composite flour-enriched cookies on the nutritional status of malnourished children. Malnutrition remains a critical public health issue, particularly in low-resource settings, necessitating the development of affordable and nutrient-rich food-based interventions.
Prior to the intervention, composite cookies were formulated using soy, chickpea, and peanut to enhance protein and energy density. The developed product was evaluated through comprehensive analysis, including proximate composition, physicochemical properties, and sensory evaluation, to ensure nutritional adequacy and acceptability.
The study included 60 children aged 3-10 years diagnosed with moderate to severe malnutrition. Participants were randomly assigned to either the intervention group or the control group. The intervention group received daily supplementation with the developed composite cookies, while the control group continued their usual diet without supplementation.
The intervention period lasted for three months. Anthropometric measurements, including weight-for-age, BMI-for-age, and mid-upper arm circumference (MUAC), were recorded at baseline and at the end of the intervention. In addition, biochemical parameters such as hemoglobin and serum albumin levels were assessed to evaluate improvements in nutritional and physiological status.
The primary objective was to assess improvement in anthropometric indicators, while secondary outcomes included changes in biochemical parameters and overall health status. The findings of this study support the potential use of locally produced, nutrient-dense functional foods as sustainable strategies to combat childhood malnutrition.
- Being tested
- Composite Flour Cookies
- Keywords
- Malnutrition, Child Nutrition, Dietary Intervention, Composite Flour cookies, Nutritional Supplementation
- Medical subject headings
- Malnutrition, Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite Flour CookiesDietary supplement
One serving(5 cookies) constituting 50g supplemented cookies (T3) were provided as a daily dietary supplement to improve nutritional status in malnourished children over a period of three months.
| Study group | Role | What they receive |
|---|---|---|
| Composite Cookie Group | Experimental | Participants in this group received daily supplementation with composite flour cookies prepared from 40% Wheat and 60% composite flour(soy, chickpea, and peanut) (T3) , along with their regular diet for a duration of three months. Receives: Dietary Supplement: Composite Flour Cookies |
| Control Group | No intervention | Participants in this group continued their regular diet without receiving any nutritional supplementation during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight-for-Age Z-score (WAZ)
Change in weight-for-age Z-score calculated using WHO Child Growth Standards based on measured body weight (kg) from baseline to 3 months
Measured: Baseline and monthly up to 3 months
Change in Height-for-Age Z-score (HAZ)
Change in height-for-age Z-score calculated using WHO Child Growth Standards based on measured height (cm) from baseline to 3 months.
Measured: Baseline and monthly up to 3 months
Change in BMI-for-Age Z-score (BAZ)
Change in BMI-for-age Z-score calculated using WHO Child Growth Standards based on BMI (kg/m²) from baseline to 3 months
Measured: Baseline and monthly up to 3 months
Change in Mid-Upper Arm Circumference (MUAC)
Change in MUAC measured in centimeters (cm) using a non-stretchable MUAC tape from baseline to 3 months and interpreted according to WHO MUAC classification criteria
Measured: Baseline and monthly up to 3 months
Change in Serum Albumin Levels
Change in serum albumin concentration (g/dL) measured using standard biochemical laboratory methods at baseline and at 3 months
Measured: Baseline and monthly over a 3-month period
Change in Hemoglobin
Change in hemoglobin levels (g/dL) measured using standard laboratory methods from baseline to 3 months to assess anemia status
Measured: Baseline and monthly up to 3 months
Change in Physical Signs of Malnutrition
Assessment of clinical signs of malnutrition (e.g., muscle wasting, hair thinning, pale skin) using clinical examination based on PYMS criteria Unit of Measure: Presence/absence
Measured: Baseline and monthly up to 3 months
Change in Daily Energy Intake
Daily energy intake (kcal/day) assessed using Food Frequency Questionnaire (FFQ) at baseline and caregiver-maintained food diary during follow-up, analyzed using NutriSurvey software
Measured: Baseline and monthly up to 3 months
Change in Daily Protein Intake
Daily protein intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software
Measured: Baseline and monthly up to 3 months
Change in Daily Carbohydrate Intake
Daily carbohydrate intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software
Measured: Baseline and monthly up to 3 months
Change in Daily Fat Intake
Daily fat intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software
Measured: Baseline and monthly up to 3 months
Change in Appetite Score
Appetite level assessed using caregiver-reported dietary intake patterns and food diary records, including frequency and quantity of meals consumed Unit of Measure: Score / qualitative assessment
Measured: Baseline and monthly up to 3 months
Change in Energy and Fatigue Levels
Energy levels and fatigue assessed through caregiver-reported observations of child activity, alertness, and daily functioning Unit of Measure: Qualitative assessment (improved / no change / worsened)
Measured: Baseline and monthly up to 3 months
Secondary outcomes (5)
Sensory Acceptability Score
Sensory evaluation of cookies including taste, texture, aroma, and overall acceptability assessed using a 9-point hedonic scale (1 = dislike extremely, 9 = like extremely). Evaluation conducted by a trained panel (n=12) under standard ethical guidelines
Measured: Baseline
Physical Properties
Diameter (mm), thickness (mm), and spread ratio measured using standard AACC (2000) methods
Measured: Baseline
Phytochemical Composition
Phytochemical constituents including total phenolic content (GAE/g), total flavonoid content (QE/g), saponins, isoflavones, and phytosterols (mg/100 g) determined using standard validated analytical methods
Measured: Baseline
Mineral Content
Iron, calcium, zinc, magnesium, and phosphorus (mg/100 g) determined using AOAC (2012) methods and atomic absorption spectrophotometry
Measured: Baseline
Proximate Composition
Moisture, protein, fat, ash, fiber, and carbohydrate content (%) determined using standard methods (AACC, 2000)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 May 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition (Calorie)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned into two groups: an intervention group receiving composite flour cookies and a control group receiving a regular diet without supplementation.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mairaj Noor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mairaj Noor, Pir Mehr Ali Shah Arid Agriculture University
- Investigators
- Mairaj Noor, Masters in Science (MS), Principal investigator, Pir Mehr Ali Shah Arid Agriculture University Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504133
- Sponsor's protocol ID
- PMAS-COOKIE-RCT-2024
- Acronym
- CFC-MAL
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations of pediatric participants. Data are stored securely and were collected solely for academic research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Composite Flour-Enriched Cookies on Clinical Outcomes of Malnourished Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07504133
- Acronym / sponsor ID
- CFC-MAL / PMAS-COOKIE-RCT-2024
- Keywords
- Malnutrition, Child Nutrition, Dietary Intervention, Composite Flour cookies, Nutritional Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mairaj NoorUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 31 Mar 2026 (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.
Malnutrition is a major public health concern among children in developing countries, leading to impaired growth and increased risk of morbidity. This study evaluated the effectiveness of nutrient-dense composite flour cookies as a dietary intervention to improve the nutritional status of malnourished children.
Composite cookies were developed using soy, chickpea, and peanut, and were subjected to nutritional and quality analysis including proximate composition and other physicochemical assessments prior to intervention. A randomized controlled trial was conducted among 60 malnourished children aged 3 to 10 years, divided into intervention and control groups.
The intervention group received the composite cookies along with their regular diet, while the control group continued with their usual diet. Anthropometric indicators including weight, body mass index (BMI), and mid-upper arm circumference (MUAC), as well as biochemical parameters such as hemoglobin and serum albumin, were assessed at baseline and after a 3-month intervention period.
The study aimed to determine whether supplementation with nutrient-rich composite cookies could significantly improve growth and nutritional outcomes in malnourished children.
Detailed description
This randomized controlled trial was conducted to evaluate the impact of composite flour-enriched cookies on the nutritional status of malnourished children. Malnutrition remains a critical public health issue, particularly in low-resource settings, necessitating the development of affordable and nutrient-rich food-based interventions.
Prior to the intervention, composite cookies were formulated using soy, chickpea, and peanut to enhance protein and energy density. The developed product was evaluated through comprehensive analysis, including proximate composition, physicochemical properties, and sensory evaluation, to ensure nutritional adequacy and acceptability.
The study included 60 children aged 3-10 years diagnosed with moderate to severe malnutrition. Participants were randomly assigned to either the intervention group or the control group. The intervention group received daily supplementation with the developed composite cookies, while the control group continued their usual diet without supplementation.
The intervention period lasted for three months. Anthropometric measurements, including weight-for-age, BMI-for-age, and mid-upper arm circumference (MUAC), were recorded at baseline and at the end of the intervention. In addition, biochemical parameters such as hemoglobin and serum albumin levels were assessed to evaluate improvements in nutritional and physiological status.
The primary objective was to assess improvement in anthropometric indicators, while secondary outcomes included changes in biochemical parameters and overall health status. The findings of this study support the potential use of locally produced, nutrient-dense functional foods as sustainable strategies to combat childhood malnutrition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned into two groups: an intervention group receiving composite flour cookies and a control group receiving a regular diet without supplementation.
| Arm | Type | Receives |
|---|---|---|
| Composite Cookie Group | Experimental | Dietary Supplement: Composite Flour CookiesParticipants in this group received daily supplementation with composite flour cookies prepared from 40% Wheat and 60% composite flour(soy, chickpea, and peanut) (T3) , along with their regular diet for a duration of three months. |
| Control Group | No intervention | –Participants in this group continued their regular diet without receiving any nutritional supplementation during the study period. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 3-10 years diagnosed with malnutrition .
- Children willing to participate in the study.
- Participants whose parents or guardians provided informed consent.
- Children attending the selected hospital for nutritional assessment.
Key exclusion criteria (4 listed)
- Children with severe chronic illnesses or metabolic disorders.
- Children with food allergies to ingredients used in the composite cookies (wheat, soy, chickpea, peanut).
- Children receiving other nutritional supplements during the study period.
- Children with severe acute medical conditions requiring hospitalization.
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 |
|---|---|---|
| Composite Flour CookiesOne serving(5 cookies) constituting 50g supplemented cookies (T3) were provided as a daily dietary supplement to improve nutritional status in malnourished children over a period of three months. | Dietary supplement | Composite Cookie Group |
Primary outcome
Change in Weight-for-Age Z-score (WAZ)
Time frame: Baseline and monthly up to 3 months
Change in weight-for-age Z-score calculated using WHO Child Growth Standards based on measured body weight (kg) from baseline to 3 months
Change in Height-for-Age Z-score (HAZ)
Time frame: Baseline and monthly up to 3 months
Change in height-for-age Z-score calculated using WHO Child Growth Standards based on measured height (cm) from baseline to 3 months.
Change in BMI-for-Age Z-score (BAZ)
Time frame: Baseline and monthly up to 3 months
Change in BMI-for-age Z-score calculated using WHO Child Growth Standards based on BMI (kg/m²) from baseline to 3 months
Change in Mid-Upper Arm Circumference (MUAC)
Time frame: Baseline and monthly up to 3 months
Change in MUAC measured in centimeters (cm) using a non-stretchable MUAC tape from baseline to 3 months and interpreted according to WHO MUAC classification criteria
Change in Serum Albumin Levels
Time frame: Baseline and monthly over a 3-month period
Change in serum albumin concentration (g/dL) measured using standard biochemical laboratory methods at baseline and at 3 months
Change in Hemoglobin
Time frame: Baseline and monthly up to 3 months
Change in hemoglobin levels (g/dL) measured using standard laboratory methods from baseline to 3 months to assess anemia status
Change in Physical Signs of Malnutrition
Time frame: Baseline and monthly up to 3 months
Assessment of clinical signs of malnutrition (e.g., muscle wasting, hair thinning, pale skin) using clinical examination based on PYMS criteria Unit of Measure: Presence/absence
Change in Daily Energy Intake
Time frame: Baseline and monthly up to 3 months
Daily energy intake (kcal/day) assessed using Food Frequency Questionnaire (FFQ) at baseline and caregiver-maintained food diary during follow-up, analyzed using NutriSurvey software
Change in Daily Protein Intake
Time frame: Baseline and monthly up to 3 months
Daily protein intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software
Change in Daily Carbohydrate Intake
Time frame: Baseline and monthly up to 3 months
Daily carbohydrate intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software
Change in Daily Fat Intake
Time frame: Baseline and monthly up to 3 months
Daily fat intake (g/day) assessed using FFQ and food diary, analyzed using NutriSurvey software
Change in Appetite Score
Time frame: Baseline and monthly up to 3 months
Appetite level assessed using caregiver-reported dietary intake patterns and food diary records, including frequency and quantity of meals consumed Unit of Measure: Score / qualitative assessment
Change in Energy and Fatigue Levels
Time frame: Baseline and monthly up to 3 months
Energy levels and fatigue assessed through caregiver-reported observations of child activity, alertness, and daily functioning Unit of Measure: Qualitative assessment (improved / no change / worsened)
5 secondary outcomes
Sensory Acceptability Score
Time frame: Baseline
Physical Properties
Time frame: Baseline
Phytochemical Composition
Time frame: Baseline
Mineral Content
Time frame: Baseline
Proximate Composition
Time frame: Baseline
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 31 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations of pediatric participants. Data are stored securely and were collected solely for academic research purposes.
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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.
Mairaj Noor, Masters in Science (MS) principal investigator
Pir Mehr Ali Shah Arid Agriculture University Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Composite Flour Cookies in people with Malnutrition (Calorie) and Protein-energy Malnutrition, run by Mairaj Noor at 1 site in Pakistan.
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 4 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 31 Mar 2026. 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 Pakistan. 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?
Change in Weight-for-Age Z-score (WAZ) (time frame: Baseline and monthly up to 3 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2026.