Moderate Acute Malnutrition (MAM)LAFNCT07506213

Development, Feasibility and Acceptability of Recipes for Locally Available, Specially Formulated Foods for the Management of Moderate Acute Malnutrition in Niger (Related to NCT06382857 Protocol)

A study testing Locally Available Food in people with Moderate Acute Malnutrition (MAM), run by Epicentre at 1 site in Niger.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 to 23 months
Conditions the study is for: Moderate Acute Malnutrition (MAM)
What is being tested?: Locally Available Food
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteNiger
Study dates: 19 Aug 2022to 11 Nov 2022
Phase: Interventional

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 6 to 23 months
All sexes
No healthy volunteers
Child

Who may be able to join

Moderate acute malnutrition (MAM)
Eat semi-solid or solid foods for at least 30 days
Written informed consent obtained from the child's legal guardian

Who cannot join

Contraindication/allergy to any locally available ingredient of the LA-SFF recipes generated in Phase 1 Recipe Development
Live outside of the study catchment area or their caregiver planned to move outside of the study catchment area in the next month
Severe acute malnutrition (SAM)
Medical complications requiring hospital based treatment

Trial locations and contacts

1 site in 1 country.

Niger1 site

Community
Madarounfa, Maradi Region

Other trials in Niger

About this study

Official title: Development, Feasibility and Acceptability of Recipes for Locally Available, Specially Formulated Foods for the Management of Moderate Acute Malnutrition in Niger: a Randomized Crossover Feeding Study With Home-use Evaluation

The study consisted of two phases. Phase 1 was a recipe development phase, which aimed to identify recipes that meet ≥80% of the recommended nutrient profile for Specially Formulated Foods (SFF) used in the standard management of MAM and made with locally available ingredients. In Phase 2, the recipes developed during Phase 1 were evaluated for acceptability among children 6 to < 24 months of age with MAM during a randomized crossover feeding study with a 30-minute observed test dose and evaluation of at-home use.

Conditions: Moderate Acute Malnutrition (MAM)
Being tested: Locally Available Food
Keywords: LAF, MAM, Moderate acute malnutrition, wasting, locally available foods, supplementary food, specially formulated foods, Niger, linear programming, lipid-based nutrient supplements, acceptability
Medical subject headings: Cachexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Locally Available FoodOther
Phase 1 of the present study developed supplementary food recipes using locally available, non-perishable ingredients. Market surveys identified 49 foods, reduced to 30 suitable items. Using linear programming in the Cost of the Diet software, 24 recipes meeting ≥80% of the nutrient profile for standard MAM treatment were generated, each including 2 g of micronutrient powder. A 2022 market survey in Maradi assessed prices and year-round availability; only six recipes met this requirement and were selected. A standardized method for at-home preparation of each recipe was developed.

Study groups in NCT07506213
Study group	Role	What they receive
Recipe #1	Experimental	* 45g wheat, bran * 10g cowpea, uncooked * 39g sesame butter, tahini * 25g fish, dried fresh water * 3g leaf, drumstick, dried * 9g baobab, pulp, flour * 2g MNP, WFP 2022 Receives: Other: Locally Available Food
Recipe #2	Experimental	* 44g wheat, bran * 16g cowpea, uncooked * 38g fish, dried fresh water * 3g leaf, drumstick, dried * 9g baobab, pulp, flour * 20g oil, vegetable * 2g MNP, WFP 2022 Receives: Other: Locally Available Food
Recipe #12	Experimental	* 34g sesame butter, tahini * 16g okra, dried * 14g bean, african locust, fermented, dried * 46g fish, dried fresh water * 19g leaf, baobab, dried * 7g baobab, pulp, flour * 2g MNP, WFP 2022 Receives: Other: Locally Available Food
Recipe #20	Experimental	* 24g cowpea, uncooked * 4g groundnut, flour with fat * 90g fish, sardines in oil, canned * 24g leaf, drumstick, dried * 8g baobab, pulp, flour * 10g oil, vegetable * 20g beef, dried, boneless * 2g MNP, WFP 2022 Receives: Other: Locally Available Food
Recipe #22	Experimental	* 32g millet, finger * 7g cowpea, uncooked * 11g sesame butter, tahini * 10g groundnut paste * 20g groundnut, flour with fat * 8g fish, dried fresh water * 4g leaf, drumstick, dried * 16g leaf, baobab, dried * 8g baobab, pulp, flour * 4g oil, vegetable * 2g MNP, WFP 2022 Receives: Other: Locally Available Food
Recipe #24	Experimental	* 166g okra, dried * 8g fish, dried fresh water * 14g Leaf, drumstick, dried * 23g oil, groundnut * 2g MNP, WFP 2022 Receives: Other: Locally Available Food

What is being measured

The primary outcome is the main question the study is designed to answer.

Observed test dose acceptability
Consumption of ≥ 75% of the 50 g test dose within 30 minutes
Measured: During 30 minutes of test dose administration
At-home observation acceptability
Consumption of ≥ 75% of the caregiver-prepared recipe within the 12-hour observation period
Measured: 12 hours

Secondary outcomes (6)

Observed test dose consumption
Consumption (defined as grams of food provided at the start of the test dose minus grams of food left at the conclusion of the test dose)
Measured: During 30 minutes of test dose administration
Observed test dose recipe organoleptic ratings
Taste, smell, odor, color, and overall as reported by the caregiver on a 5-point Likert scale (1 = "dislike a lot" and 5 = "like a lot").
Measured: Following completion of the 30-minute test dose period
Observed test dose perceived child liking
Perceived child liking as reported by the caregiver on a 5-point Likert scale (1 = "dislike a lot" and 5 = "like a lot")
Measured: Following completion of the 30-minute test dose period
At-home observation recipe organoleptic ratings
Taste, smell, odor, color, and overall as reported by the caregiver on a 5-point Likert scale (1 = "dislike a lot" and 5 = "like a lot")
Measured: 12 hours (7AM - 7PM on at-home observation day)
At-home observation child willingness to eat the food
Voluntarily eaten, encouraged to consume, rejected
Measured: 12 hours (7AM - 7PM on at-home observation day)
At-home observation caregiver willingness to use the recipe in the future
As reported on a 5-point Likert scale (1 = "not at all willing" and 5 = "extremely willing")
Measured: 12 hours (7AM - 7PM on at-home observation day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 202211 Nov 2022

First posted1 Apr 2026
Study start19 Aug 2022
Primary completion11 Nov 2022
Study completion11 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Moderate Acute Malnutrition (MAM)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Model description: The study had two phases. * Phase 1 (Recipe Development) focused on developing supplementary food recipes using locally available, non-perishable ingredients. Market surveys identified 49 foods, reduced to 30 suitable items. Using linear programming in the Cost of the Diet software, 24 recipes meeting ≥80% of the nutrient profile for standard MAM treatment were generated, each including 2 g of micronutrient powder. A 2022 market survey in Maradi assessed prices and year-round availability; only six recipes met this requirement and were selected. A standardized method for at-home preparation was developed. * In Phase 2 (Recipe Evaluation), six recipes developed in Phase 1 were tested in a randomized crossover study among children 6-\<24 months with MAM. The six recipes were evaluated over two days using an observed test dose at a health center, and the most acceptable recipe from the observed test dose was further evaluated during two days of at-home use.
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07506213
Sponsor's protocol ID: LAF MAM Niger
Other IDs: INV-023315
Acronym: LAF
Status last verified: Apr 2026
First submitted: 26 Mar 2026
Last updated: 7 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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