ClinicalTrials.gg
CompletedNCT07506213LAFUpdated Apr 7, 2026

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)

An interventional study of Locally Available Food in Moderate Acute Malnutrition (MAM), sponsored by Epicentre. Completed at 1 site in Niger. Open to participants aged 6 Months to 23 Months. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Epicentre · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Aug 2022, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
6 Months to 23 Months
Sex
All
01

Study summary

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.

02

Conditions studied

  • Moderate Acute Malnutrition (MAM)

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Keywords

  • LAF
  • MAM
  • Moderate acute malnutrition
  • wasting
  • locally available foods
  • supplementary food
  • specially formulated foods
  • Niger
  • linear programming
  • lipid-based nutrient supplements
  • acceptability
03

In context

Cachexia

331 studies on the registry are indexed under Cachexia; 75 are open to participants now.

This study's enrollment of 30 is below the median of 74 across 226 interventional studies indexed under Cachexia.

Browse Cachexia studies →

Lead sponsor

Epicentre is the lead sponsor of 49 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 23 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • /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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Recipe #1

    * 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

    Other: Locally Available Food

  • Experimental
    Recipe #2

    * 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

    Other: Locally Available Food

  • Experimental
    Recipe #12

    * 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

    Other: Locally Available Food

  • Experimental
    Recipe #20

    * 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

    Other: Locally Available Food

  • Experimental
    Recipe #22

    * 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

    Other: Locally Available Food

  • Experimental
    Recipe #24

    * 166g okra, dried * 8g fish, dried fresh water * 14g Leaf, drumstick, dried * 23g oil, groundnut * 2g MNP, WFP 2022

    Other: Locally Available Food

Interventions

  • OtherLocally Available Food

    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.

06

What researchers measure

Primary outcomes

  1. Observed test dose acceptability

    Consumption of ≥ 75% of the 50 g test dose within 30 minutes

    Time frame: During 30 minutes of test dose administration

  2. At-home observation acceptability

    Consumption of ≥ 75% of the caregiver-prepared recipe within the 12-hour observation period

    Time frame: 12 hours

Secondary outcomes

  1. 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)

    Time frame: During 30 minutes of test dose administration

  2. 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").

    Time frame: Following completion of the 30-minute test dose period

  3. 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")

    Time frame: Following completion of the 30-minute test dose period

  4. 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")

    Time frame: 12 hours (7AM - 7PM on at-home observation day)

  5. At-home observation child willingness to eat the food

    Voluntarily eaten, encouraged to consume, rejected

    Time frame: 12 hours (7AM - 7PM on at-home observation day)

  6. 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")

    Time frame: 12 hours (7AM - 7PM on at-home observation day)

07

Study locations

1 site
  • Community
    Madarounfa, Maradi Region, Niger
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2022 to primary completion in Nov 2022, 2 months.

Of 75 non-industry interventional studies with no phase under Cachexia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 49. This study's 2 months is below that.

Counting every sponsor, half of 77 studies reached it within 19 months; a quarter within 12 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2026
First posted
Apr 1, 2026
StartActual
Aug 19, 2022
Primary completionActual
Nov 11, 2022
CompletionActual
Nov 11, 2022
Last update
Apr 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07506213
Lead sponsor
Epicentre
Responsible party
Sponsor
First posted
Apr 1, 2026
Start date
Aug 19, 2022
Primary completion
Nov 11, 2022
Completion
Nov 11, 2022
Last update
Apr 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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