Acceptability of Folic Acid and Vitamin B12 Fortified Meals

NCT06094049 | Recruiting

• 1 other identifier: ONZ-2023-0137-B
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Dietary Habits

Keywords

Folic acid fortified meal; Vitamin B12 fortified meal; Preference test; Triangle test

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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.

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.

Other: Triangle test group

Interventions

Preference test group 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.

Preference test

Triangle test group 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.

Triangle test

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Ghent: lead
• Arba Minch University: collaborator
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator
• Addis Ababa University: collaborator

Study Sites (2)

Arba Minch Health and Demographic Surveillance System sites

Arba Minch, 21, Ethiopia

RECRUITING

Arba Minch University

Arba Minch, Ethiopia

NOT YET RECRUITING

Related 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.

  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.

  PMID: 33083093 BACKGROUND

• 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.

  PMID: 35735352 BACKGROUND

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

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Stefaan De Henauw, MD, PHD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Souheila Abbeddou, MSc. PHD

CONTACT

+32467630892; Souheila.Abbeddou@UGent.be

Eshetu Tariku, MPH

CONTACT

+251917835302; eshetuzerihun.tariku@ugent.be

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 23, 2023
• Study Start: September 6, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ET (2)