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.
Trial 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. Read more about this study
- 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
- Are there results?
- None posted in the registry
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07506213
- Acronym / sponsor ID
- LAF / LAF MAM Niger
- Conditions
- Moderate Acute Malnutrition (MAM)
- Keywords
- LAF, MAM, Moderate acute malnutrition, wasting, locally available foods, supplementary food, specially formulated foods, Niger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| Recipe #1 | Experimental | Other: Locally Available Food* 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 |
| Recipe #2 | Experimental | Other: Locally Available Food* 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 |
| Recipe #12 | Experimental | Other: Locally Available Food* 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 |
| Recipe #20 | Experimental | Other: Locally Available Food* 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 |
| Recipe #22 | Experimental | Other: Locally Available Food* 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 |
| Recipe #24 | Experimental | Other: Locally Available Food* 166g okra, dried * 8g fish, dried fresh water * 14g Leaf, drumstick, dried * 23g oil, groundnut * 2g MNP, WFP 2022 |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locally Available FoodPhase 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. | Other | Recipe #1, Recipe #12, Recipe #2, Recipe #20, Recipe #22, Recipe #24 |
Primary outcome
Observed test dose acceptability
Time frame: During 30 minutes of test dose administration
Consumption of ≥ 75% of the 50 g test dose within 30 minutes
At-home observation acceptability
Time frame: 12 hours
Consumption of ≥ 75% of the caregiver-prepared recipe within the 12-hour observation period
6 secondary outcomes
Observed test dose consumption
Time frame: During 30 minutes of test dose administration
Observed test dose recipe organoleptic ratings
Time frame: Following completion of the 30-minute test dose period
Observed test dose perceived child liking
Time frame: Following completion of the 30-minute test dose period
At-home observation recipe organoleptic ratings
Time frame: 12 hours (7AM - 7PM on at-home observation day)
At-home observation child willingness to eat the food
Time frame: 12 hours (7AM - 7PM on at-home observation day)
At-home observation caregiver willingness to use the recipe in the future
Time frame: 12 hours (7AM - 7PM on at-home observation day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locally Available Food in people with Moderate Acute Malnutrition (MAM), run by Epicentre at 1 site in Niger.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Niger. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed test dose acceptability (time frame: During 30 minutes of test dose administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.