Trial on the Acceptability of Modified Lipid Based Nutrient Supplements Among Malawian Infants

Study Overview
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Brief Summary
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The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. The investigators' study group has developed modified versions of such supplements that theoretically will supplement infants diets better and with lower cost. As a preparation for larger efficacy trials, the investigators now aim to test the acceptability of these supplements among Malawian infants and their guardians. The trial hypothesis is that the infants will consume on average at least 50% of an offered dose that consists of LNS mixed with maize porridge.

Detailed Description
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In the first phase, 18 infants meeting set criteria are randomised into receiving three test meals with novel LNS preparations over a three-day period. The meals will consists of the following, each given on one day and in a random order: 1) 7.5 g of LNS-10gM mixed in 30 g maize-soy porridge, 2) 15 g of LNS-20gM mixed in 30 g maize-soy porridge, 3) 15 g of LNS-20gNoM mixed in 30 g maize-soy porridge. As a run in procedure, each participant will undergo a test feeding session with one of the the test foods on the day before the actual test-feeding period. As a positive control, each participant will undergo test feeding session with standard Nutributter (NB) on the day after the actual test-feeding period. In the second phase a set of 48 infants are randomised into 3 groups receiving the following food supplements for a period of 2 weeks: 1) 10 g/day of milk-containing, very concentrated LNS (LNS-10gM), 2) 20 g/day of milk-containing, concentrated LNS (LNS-20gM), 3) 20 g/day of milk-free, concentrated LNS (LNS-20 g NoM) Outcomes measures in the first phase will be assessed through safety reports and quantities of test food consumed by the child and a hedonic scale of acceptability by the mothers of the children. The second phase will be assessed with qualitative outcomes, from data obtained from focus group discussions with the guardians of the infants consuming the test foods.

Official Title
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Differential Acceptability of New Lipid Based Nutrient Supplement (LNS) Formulations for Prevention of Moderate Malnutrition

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Nutributter
* Dietary Supplement: LNS-20gM
* Dietary Supplement: LNS-20gNoM
* Dietary Supplement: LNS-10gM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent from at least one guardian Age 7.50 months to 11.49 months Currently breastfeeding Consuming complementary feeds at least 30 days prior to enrollment Availability during the period of the study Exclusion Criteria: Weight for length Z score (WFH) ≤ -2.0 using WHO growth reference standards or the -presence of oedema Severe systemic illness warranting hospital referral History of allergy towards peanut History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care Congenital malformation such as cleft palate which may interfere with food intake Concurrent participation in any other clinical trial

Ages Eligible for Study
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Minimum Age: 8 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Nutributter|Test dose of standard supplementary lipid based nutrient supplement (LNS). 15 grams of Nutributter will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.|
|Dietary Supplement: LNS-20gM|Test dose of modified LNS-20gM supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-20gM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.|
|Dietary Supplement: LNS-20gNoM|Test dose of modified LNS-20gNoM (milk free) supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-20gNoM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.|
|Dietary Supplement: LNS-10gM|Test dose of modified LNS-10gM supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-10gM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean amount (in grammes) of test food consumed |  | within 15 minutes of test feeding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time taken to consume the intervention dose |  | 15 minutes after test feeding | 
| Mean rating by the guardians (on a hedonic, 5 point scale) |  | 15 minutes after test feeding | 
| Overall guardian feedback after a two week supplementation period (qualitative analysis of focus group discussions) |  | Once, when the children have completed a two-week supplementary feeding period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stunting, Growth failure, Malnutrition, Lipid based nutrient supplement, LNS, Prevention, Malawi, Sub-Saharan Africa, Dietary supplementation