Dietary HabitsNCT06094049
Acceptability of Folic Acid and Vitamin B12 Fortified Meals
An observational study of Dietary Habits, run by University Ghent at 2 sites in Ethiopia.
Trial summary
Evaluation of sensory acceptability of fortified products prior to distribution is essential. We aim to evaluate whether fortification affects sensory qualities and whether these are acceptable to rural communities. Standard meals will be prepared using unfortified and fortified-flour with folic acid and vitamin B12. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits
- What is being tested?
- Preference test group and Triangle test group
- How many people
- 72 participants
- Where
- 2 sitesEthiopia
- Study dates
- 6 Sep 2023to 31 Dec 2025
- Phase
- Observational
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The sensory assessors (the panelists) will be WRAG, 15-49 years of age. This population group is mainly selected for this trial because: 1) the purpose of acceptability trail in this study is to test how the product will be liked by the local community, but not meant for the commercial use; 2) women's in Ethiopia are highly involved in food preparation and known to have a better understanding of meals characteristics; 2) the major target of intervention for the fortified product will be women.
Who may be able to join
- Women of reproductive age (WRAG) between the ages of 15-49 years who live in households at AM-HDSS and who are:
- One or both of their parents signed an informed consent form and the girl's agreed if the participant is a teenage. A signed consent from women >19 years of age.
- Commonly participating in the food preparation
- With general good health
- Literate (able to read and write)
Who cannot join
- WRAG who are pregnant and/or are lactating
- WRAG with diagnosed/reported food allergies and food intolerances toward the prepared food
Trial locations and contacts
2 sites in 1 country.
Ethiopia2 sites, 2 recruiting
- Recruiting
Arba Minch Health and Demographic Surveillance System sites
Arba Minch, 21
Eshetu Zerihun Tariku, eshetuzerihun.tariku@ugent.be
Stefaan De Henauw, 003293323679, Stefaan.DeHenauw@UGent.Be
- Not yet recruiting
Arba Minch University
Arba Minch
Eshetu Tariku Zerihun, MPH, EshetuZerihun.Tariku@UGent.be
Muluken Bekele Sorrie, MPH, MulukenBekele.Sorrie@UGent.be
About this study
Official title: Evaluation of Acceptability of Folic Acid and Vitamin B12 Fortified Meals by Rural Communities of Ethiopia
Evaluation of sensory acceptability of fortified products prior to distribution is essential. We aim to evaluate whether fortification affects sensory qualities and whether these are acceptable to rural communities. Standard meals will be prepared using unfortified and fortified-flour with folic acid and vitamin B12. Preference and triangle tests will be conducted among women residing in rural areas of Ethiopia.
Read the detailed description
In Ethiopia, micronutrient deficiencies and associated morbidities remain a major public health problem that jeopardizes the development efforts of the country. Ethiopia faces a particularly high level of folate deficiency especially critical in women of reproductive age group (WRAG) (Haidar, J., 2010), which contributes to high rates of anaemia and can significantly increase the risk of Neural Tube Defects (NTDs), and neonatal and child mortality (Oumer, M., 2020; Wald, N.J., 2022). The government of Ethiopia recognizes the importance of a healthy population and thus has endorsed and implemented a number of nutrition specific and nutrition-sensitive interventions to improve the nutritional status and health of the population. Ethiopia has endorsed national multi-sectoral food and nutrition policy on November 23, 2018 to address the multifaceted nutritional problems. Ethiopia successfully implemented mandatory fortification programs for iodine, salt fortification with Iodine. More efforts and capacities are required to address similarly important and deep-rooted micronutrient deficiencies such as those of folic acid and vitamin B12. The Ministry of Health and all the health and nutrition stakeholders in Ethiopia recognize the vital importance of a preventive intervention that can reverse the current alarming rates of NTDs. Very recently, the fortification of edible oil and wheat flour with folic acid and other essential micronutrients was made mandatory in Ethiopia. However, they also are aware of the technical constraints in Ethiopia for the adoption of fortification of staple foods that are inherent in the diversity of staple foods and the scattered pattern of small mills. A large segment of vulnerable populations in Ethiopia resides in rural settings and has limited access to fortified foods in the market. Although consuming fortifiable wheat resulted in substantial decreases in the prevalence of micronutrient deficiencies in urban settings, large-scale fortified food is not a suitable approach to reaching the rural population, that depends on small scale mills for processing staple cereals such as maize, sorghum, and barley. Prior to testing the effectiveness of such intervention in improving the population health and nutrition outcomes, evaluation of the extent of sensory acceptability of the fortified products by the local community is important (Lawless et.al., 2010).
The study aims to evaluate the sensory acceptability of folic acid and vitamin B12 fortified cereal-based meals by the local communities. The evidence obtained from this trial will first provide us with a baseline understanding of potential adherence to the food made from the fortified flour, to carry on the effectiveness trial.
This study will be conducted in Arba Minch Health and Demographic Surveillance Sites (AM-HDSS) villages, Arba Minch Zuria District (AZD) and Gacho Baba District (GBD), Gamo Zone, Southern Ethiopia. The two districts have a total of 31 kebeles (the smallest administrative units in Ethiopia) with three different climatic zones, highland, midland, and lowland, among which 9 kebeles are targets of AM-HDSS, which is run by Arba Minch University. One kebele from highland and one from lowland will be selected to address the variability in food preparations techniques among kebeles of different climatic zones. To conduct the sensory acceptability test, standard meals will be prepared including the commonly consumed porridge and/or bread using unfortified flour and fortified-flour with folic acid and vitamin B12. Fortified and unfortified flour will be produced in a local meal contracted for the purpose of our project.
A preference test will be conducted among 36 WRAG using a 5-unit hedonic scale (color, test, flavor, texture/mouth feel, overall liking) with a consideration of meals prepared with fortified flour only. A triangle tests will be carried out to detect any difference between the food prepared with fortified and unfortified flour. In this test, 36 WRAG (different from the first group) will be served three bowels of the meal (one prepared from the fortified flour while the other two from non-fortified flour and vice versa) and will be asked to specify which one differs from the other two. Then if the difference is identified, the participant will be asked again to indicate whether the difference is large, medium or uncertain.
The data collection will be conducted through the combination of observation, self-administered questionnaires and interview techniques.
- Conditions
- Dietary Habits
- Being tested
- Preference test group, Triangle test group
- Keywords
- Folic acid fortified meal, Vitamin B12 fortified meal, Preference test, Triangle test
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preference test groupOther
Standard meals will be prepared including the commonly consumed porridge and/or bread using flour fortified with folic acid and vitamin B12. The meals will be prepared in the same way, by a local person who is familiar with the selected food.
Triangle test groupOther
Standard meals will be prepared including the commonly consumed porridge and/or bread using unfortified flour and fortified-flour with folic acid and vitamin B12. The meals will be prepared in the same way, by a local person who is familiar with the selected food and who will be blinded to the flour type.
| Study group | Role | What they receive |
|---|---|---|
| Preference test | A preference test using a 5-unit hedonic scale will be conducted to assess the women liking of the meal prepared with fortified flour only. Receives: Other: Preference test group | |
| Triangle test | A triangle tests will be carried out to detect any difference between the food prepared with fortified and unfortified flour. Receives: Other: Triangle test group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women liking of the meal prepared with fortified flour only
In the preference test, the degree of liking of the fortified meal will be graded based on the 5 unit hedonic scale (1= dislike very much, 2=dislike slightly 3=neither like nor dislike 4=like slightly and 5=like very much).
Measured: 1 month
The extent of perceived difference between fortified and unfortified flour by the women
Women will be served three bowels of the meal (one prepared from the fortified flour while the other two from non-fortified flour and vice versa) and will be asked to specify which one differs from the other two. Then if the difference is identified, the participant will be asked again to indicate whether the difference is large, medium or uncertain.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start6 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Arba Minch University, Institut de Recherche en Sciences de la Sante, Burkina Faso, Addis Ababa University
- Responsible party
- Sponsor
- Investigators
- Stefaan De Henauw, MD, PHD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094049
- Sponsor's protocol ID
- ONZ-2023-0137-B
- Status last verified
- May 2024
- First submitted
- 3 Oct 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haidar, J., Melaku, U. and Pobocik, R.S., 2010. Folate deficiency in women of reproductive age in nine administrative regions of Ethiopia: an emerging public health problem. South African Journal of Clinical Nutrition, 23(3), pp.132-137.
Oumer M, Taye M, Aragie H, Tazebew A. Prevalence of Spina Bifida among Newborns in Africa: A Systematic Review and Meta-Analysis. Scientifica (Cairo). 2020 Oct 6;2020:4273510. doi: 10.1155/2020/4273510. eCollection 2020.
PubMed 33083093Wald NJ. Folic acid and neural tube defects: Discovery, debate and the need for policy change. J Med Screen. 2022 Sep;29(3):138-146. doi: 10.1177/09691413221102321. Epub 2022 Jun 23.
PubMed 35735352Lawless, Harry T., and Hildegarde Heymann. Sensory evaluation of food: principles and practices. Vol. 2. New York: Springer, 2010.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acceptability of Folic Acid and Vitamin B12 Fortified Meals by Rural Communities of Ethiopia
- ClinicalTrials.gov ID
- NCT06094049
- Acronym / sponsor ID
- ONZ-2023-0137-B
- Conditions
- Dietary Habits
- Keywords
- Folic acid fortified meal, Vitamin B12 fortified meal, Preference test, Triangle test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Arba Minch University, Institut de Recherche en Sciences de la Sante, Burkina Faso, Addis Ababa University
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Oct 2023 (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.
Evaluation of sensory acceptability of fortified products prior to distribution is essential. We aim to evaluate whether fortification affects sensory qualities and whether these are acceptable to rural communities. Standard meals will be prepared using unfortified and fortified-flour with folic acid and vitamin B12. Preference and triangle tests will be conducted among women residing in rural areas of Ethiopia.
Detailed description
In Ethiopia, micronutrient deficiencies and associated morbidities remain a major public health problem that jeopardizes the development efforts of the country. Ethiopia faces a particularly high level of folate deficiency especially critical in women of reproductive age group (WRAG) (Haidar, J., 2010), which contributes to high rates of anaemia and can significantly increase the risk of Neural Tube Defects (NTDs), and neonatal and child mortality (Oumer, M., 2020; Wald, N.J., 2022). The government of Ethiopia recognizes the importance of a healthy population and thus has endorsed and implemented a number of nutrition specific and nutrition-sensitive interventions to improve the nutritional status and health of the population. Ethiopia has endorsed national multi-sectoral food and nutrition policy on November 23, 2018 to address the multifaceted nutritional problems. Ethiopia successfully implemented mandatory fortification programs for iodine, salt fortification with Iodine. More efforts and capacities are required to address similarly important and deep-rooted micronutrient deficiencies such as those of folic acid and vitamin B12. The Ministry of Health and all the health and nutrition stakeholders in Ethiopia recognize the vital importance of a preventive intervention that can reverse the current alarming rates of NTDs. Very recently, the fortification of edible oil and wheat flour with folic acid and other essential micronutrients was made mandatory in Ethiopia. However, they also are aware of the technical constraints in Ethiopia for the adoption of fortification of staple foods that are inherent in the diversity of staple foods and the scattered pattern of small mills. A large segment of vulnerable populations in Ethiopia resides in rural settings and has limited access to fortified foods in the market. Although consuming fortifiable wheat resulted in substantial decreases in the prevalence of micronutrient deficiencies in urban settings, large-scale fortified food is not a suitable approach to reaching the rural population, that depends on small scale mills for processing staple cereals such as maize, sorghum, and barley. Prior to testing the effectiveness of such intervention in improving the population health and nutrition outcomes, evaluation of the extent of sensory acceptability of the fortified products by the local community is important (Lawless et.al., 2010).
The study aims to evaluate the sensory acceptability of folic acid and vitamin B12 fortified cereal-based meals by the local communities. The evidence obtained from this trial will first provide us with a baseline understanding of potential adherence to the food made from the fortified flour, to carry on the effectiveness trial.
This study will be conducted in Arba Minch Health and Demographic Surveillance Sites (AM-HDSS) villages, Arba Minch Zuria District (AZD) and Gacho Baba District (GBD), Gamo Zone, Southern Ethiopia. The two districts have a total of 31 kebeles (the smallest administrative units in Ethiopia) with three different climatic zones, highland, midland, and lowland, among which 9 kebeles are targets of AM-HDSS, which is run by Arba Minch University. One kebele from highland and one from lowland will be selected to address the variability in food preparations techniques among kebeles of different climatic zones. To conduct the sensory acceptability test, standard meals will be prepared including the commonly consumed porridge and/or bread using unfortified flour and fortified-flour with folic acid and vitamin B12. Fortified and unfortified flour will be produced in a local meal contracted for the purpose of our project.
A preference test will be conducted among 36 WRAG using a 5-unit hedonic scale (color, test, flavor, texture/mouth feel, overall liking) with a consideration of meals prepared with fortified flour only. A triangle tests will be carried out to detect any difference between the food prepared with fortified and unfortified flour. In this test, 36 WRAG (different from the first group) will be served three bowels of the meal (one prepared from the fortified flour while the other two from non-fortified flour and vice versa) and will be asked to specify which one differs from the other two. Then if the difference is identified, the participant will be asked again to indicate whether the difference is large, medium or uncertain.
The data collection will be conducted through the combination of observation, self-administered questionnaires and interview techniques.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preference test | – | Other: Preference test groupA preference test using a 5-unit hedonic scale will be conducted to assess the women liking of the meal prepared with fortified flour only. |
| Triangle test | – | Other: Triangle test groupA triangle tests will be carried out to detect any difference between the food prepared with fortified and unfortified flour. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The sensory assessors (the panelists) will be WRAG, 15-49 years of age. This population group is mainly selected for this trial because: 1) the purpose of acceptability trail in this study is to test how the product will be liked by the local community, but not meant for the commercial use; 2) women's in Ethiopia are highly involved in food preparation and known to have a better understanding of meals characteristics; 2) the major target of intervention for the fortified product will be women.
Key inclusion criteria (5 listed)
- Women of reproductive age (WRAG) between the ages of 15-49 years who live in households at AM-HDSS and who are:
- One or both of their parents signed an informed consent form and the girl's agreed if the participant is a teenage. A signed consent from women >19 years of age.
- Commonly participating in the food preparation
- With general good health
- Literate (able to read and write)
Key exclusion criteria (2 listed)
- WRAG who are pregnant and/or are lactating
- WRAG with diagnosed/reported food allergies and food intolerances toward the prepared food
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 |
|---|---|---|
| Preference test groupStandard meals will be prepared including the commonly consumed porridge and/or bread using flour fortified with folic acid and vitamin B12. The meals will be prepared in the same way, by a local person who is familiar with the selected food. | Other | Preference test |
| Triangle test groupStandard meals will be prepared including the commonly consumed porridge and/or bread using unfortified flour and fortified-flour with folic acid and vitamin B12. The meals will be prepared in the same way, by a local person who is familiar with the selected food and who will be blinded to the flour type. | Other | Triangle test |
Primary outcome
Proportion of women liking of the meal prepared with fortified flour only
Time frame: 1 month
In the preference test, the degree of liking of the fortified meal will be graded based on the 5 unit hedonic scale (1= dislike very much, 2=dislike slightly 3=neither like nor dislike 4=like slightly and 5=like very much).
The extent of perceived difference between fortified and unfortified flour by the women
Time frame: 1 month
Women will be served three bowels of the meal (one prepared from the fortified flour while the other two from non-fortified flour and vice versa) and will be asked to specify which one differs from the other two. Then if the difference is identified, the participant will be asked again to indicate whether the difference is large, medium or uncertain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- BackgroundHaidar, J., Melaku, U. and Pobocik, R.S., 2010. Folate deficiency in women of reproductive age in nine administrative regions of Ethiopia: an emerging public health problem. South African Journal of Clinical Nutrition, 23(3), pp.132-137.
- Background: PubMed 33083093Oumer M, Taye M, Aragie H, Tazebew A. Prevalence of Spina Bifida among Newborns in Africa: A Systematic Review and Meta-Analysis. Scientifica (Cairo). 2020 Oct 6;2020:4273510. doi: 10.1155/2020/4273510. eCollection 2020.
- Background: PubMed 35735352Wald NJ. Folic acid and neural tube defects: Discovery, debate and the need for policy change. J Med Screen. 2022 Sep;29(3):138-146. doi: 10.1177/09691413221102321. Epub 2022 Jun 23.
- BackgroundLawless, Harry T., and Hildegarde Heymann. Sensory evaluation of food: principles and practices. Vol. 2. New York: Springer, 2010.
- The link to Ethiopian Food and Nutrition PolicyLink provided by the sponsor.
- Mandatory fortification regulation endorsed by EthiopiaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Dietary Habits
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.
Stefaan De Henauw, MD, PHD principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Habits, run by University Ghent at 2 sites in Ethiopia.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Souheila Abbeddou, MSc. PHD (+32467630892, Souheila.Abbeddou@UGent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women liking of the meal prepared with fortified flour only (time frame: 1 month). The study lists 2 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 NCT06094049, which also lists 4 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 8 May 2024.