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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Souheila Abbeddou, MSc. PHD contact

+32467630892

Souheila.Abbeddou@UGent.be

Ethiopia2 sites, 2 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

    Recruiting
  • Arba Minch University

    Arba Minch

    Eshetu Tariku Zerihun, MPH, EshetuZerihun.Tariku@UGent.be

    Muluken Bekele Sorrie, MPH, MulukenBekele.Sorrie@UGent.be

    Not yet recruiting

Other trials in Ethiopia

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 groups in NCT06094049
Study groupRoleWhat they receive
Preference testA 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 testA 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.

  1. 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

  2. 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.

  1. First posted23 Oct 2023
  2. Study start6 Sep 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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)
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 33083093
  • Wald 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 35735352
  • Lawless, Harry T., and Hildegarde Heymann. Sensory evaluation of food: principles and practices. Vol. 2. New York: Springer, 2010.

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.

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