Acceptability of Folic Acid and Vitamin B12 Fortified Meals

NCT ID: NCT06094049

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-06
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Dietary Habits

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Preference test group

Intervention Type: OTHER

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

A triangle tests will be carried out to detect any difference between the food prepared with fortified and unfortified flour.

Triangle test group

Intervention Type: OTHER

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.

Interventions

Preference test group

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.

Intervention Type: OTHER

Triangle test group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• WRAG who are pregnant and/or are lactating
• WRAG with diagnosed/reported food allergies and food intolerances toward the prepared food

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Arba Minch University

OTHER

Sponsor Role: collaborator

Institut de Recherche en Sciences de la Sante, Burkina Faso

OTHER_GOV

Sponsor Role: collaborator

Addis Ababa University

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefaan De Henauw, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Arba Minch Health and Demographic Surveillance System sites

Arba Minch, , Ethiopia

Site Status: RECRUITING

Arba Minch University

Arba Minch, , Ethiopia

Site Status: NOT_YET_RECRUITING

Countries

Ethiopia

Central Contacts

Souheila Abbeddou, MSc. PHD

Role: CONTACT

Souheila.Abbeddou@UGent.be

+32467630892

Eshetu Tariku, MPH

Role: CONTACT

eshetuzerihun.tariku@ugent.be

+251917835302

Facility Contacts

Eshetu Zerihun Tariku

Role: primary

eshetuzerihun.tariku@ugent.be

Stefaan De Henauw

Role: backup

Stefaan.DeHenauw@UGent.Be

003293323679

Eshetu Tariku Zerihun, MPH

Role: primary

EshetuZerihun.Tariku@UGent.be

Muluken Bekele Sorrie, MPH

Role: backup

MulukenBekele.Sorrie@UGent.be

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 33083093 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35735352 (View on PubMed)

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

Reference Type: BACKGROUND

Related Links

https://www.nipn.ephi.gov.et

The link to Ethiopian Food and Nutrition Policy

https://www.thereporterethiopia.com/25738/

Mandatory fortification regulation endorsed by Ethiopia

Other Identifiers

ONZ-2023-0137-B

Identifier Type: -

Identifier Source: org_study_id