Clinical trial NCT06094049: Acceptability of Folic Acid and Vitamin B12 Fortified Meals
Official title: Evaluation of Acceptability of Folic Acid and Vitamin B12 Fortified Meals by Rural Communities of Ethiopia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dietary Habits
Keywords: Folic acid fortified meal
Vitamin B12 fortified meal
Preference test
Triangle test
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Arba Minch University
name: Institut de Recherche en Sciences de la Sante, Burkina Faso
name: Addis Ababa University
First posted: 2023-10-23
Enrollment: 72
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Proportion of women liking of the meal prepared with fortified flour only
timeFrame: 1 month
measure: The extent of perceived difference between fortified and unfortified flour by the women
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Arba Minch
country: Ethiopia
facility: Arba Minch Health and Demographic Surveillance System sites
city: Arba Minch
country: Ethiopia
facility: Arba Minch University
Study officials:
affiliation: University Ghent
name: Stefaan De Henauw, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
citation: Lawless, Harry T., and Hildegarde Heymann. Sensory evaluation of food: principles and practices. Vol. 2. New York: Springer, 2010.