Acceptability of Folic Acid and Vitamin B12 Fortified Meals

Dietary Habits Clinical Trial

Official title:

Evaluation of Acceptability of Folic Acid and Vitamin B12 Fortified Meals by Rural Communities of Ethiopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094049
• Other study ID #: ONZ-2023-0137-B
• Status: Recruiting
• Start date: September 6, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University Ghent
• Contact: Souheila Abbeddou, MSc. PHD
• Phone: +32467630892
• Email: Souheila.Abbeddou[@]UGent.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Preference and triangle tests will be conducted among women residing in rural areas of Ethiopia.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Habits

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Ethiopia	Arba Minch Health and Demographic Surveillance System sites	Arba Minch
Ethiopia	Arba Minch University	Arba Minch

Sponsors (4)

Lead Sponsor	Collaborator
University Ghent	Addis Ababa University, Arba Minch University, Institut de Recherche en Sciences de la Sante, Burkina Faso

Country where clinical trial is conducted

Ethiopia, 

References & Publications (4)

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.

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

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. — View Citation

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. Erratum In: J Med Screen. 2022 Sep;29(3):147. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 month
Primary	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.	1 month

External Links

•   Mandatory fortification regulation endorsed by Ethiopia
•   The link to Ethiopian Food and Nutrition Policy