Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?

Not Applicable

Completed

• Conditions: Malnutrition, Child
• Interventions: Dietary Supplement: RUSF skimmed milk powder; Dietary Supplement: RUSF milk protein concentrate and sucrose; Dietary Supplement: RUSF soy protein and whey permeate; Dietary Supplement: RUSF soy and sucrose

• Registration Number: NCT04216043
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This study is to look at the types of sugar and protein composition in the treatment of moderate acute malnutrition and its effects on gut health. The study will use 4 different types of ready to use supplementary foods to see which one if any has better recovery rate along with looking into the gut health. Children will be treated using one food for up to 12 weeks. A subset of about 400 will be tested for intestinal permeability using the dual sugar test.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Study Start: 2020-09-16
• Primary Completion: 2022-03-07
• Study Completion: 2022-03-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1102

Inclusion Criteria

• MUAC < 12.5 cm and ≥ 11.5 cm without bipedal oedema

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Exclusion Criteria

• If they are involved in another research trial
• in another supplemental feeding program
• debilitating illness
• history of peanut or milk allergy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RUSF skimmed milk powder	RUSF skimmed milk powder	RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
RUSF milk protein concentrate and sucrose	RUSF milk protein concentrate and sucrose	RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
RUSF soy protein and whey permeate	RUSF soy protein and whey permeate	RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.
RUSF soy and sucrose	RUSF soy and sucrose	RUSF will provide 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child, to feed it in addition to their usual diet, and to use daily portions.

Primary Outcome Measures

Name	Time	Method
% lactulose excretion after 4 weeks of supplementary feeding	4 weeks	This will only be assessed in children with higher-risk (MUAC \< 12 cm) MAM at baseline.; %L measured in the urine relative to the amount ingested will be calculated. %L will be categorized as normal (\<0.2%) and abnormal (\>0.2)
16S rRNA relative abundance of bacterial taxa after 4 weeks of supplementary feeding	4 weeks	This will only be assessed in children with higher-risk (MUAC \< 12 cm) MAM at baseline

Secondary Outcome Measures

Name	Time	Method
Final mid-upper arm circumference	up to 12 weeks of treatment	Use the mid-upper are circumference at the visit when outcome was reached
Proportion with %L < 0.20	4 weeks	Percentage of children with %L excreted \< 0.20
16S rRNA alpha-diversity at week 4	4 weeks	Several metrics of alpha diversity will be assessed, including Shannon's index
Rate of weight gain (g/kg/d)	up to 12 weeks of treatment	Changes in weight relative to baseline weight
Rate of length gain (mm/week)	up to 12 weeks of treatment	Changes in linear growth
16S rRNA beta-diversity at week 4	4 weeks	Looking at the 16S configuration in stool samples collected
Rate of deteriorating to severe acute malnutrition or death	up to 12 weeks of treatment	Severe acute malnutrition defined by MUAC \< 11.5 cm or development of nutritional edema
Sub-group analysis of %L and 16S rRNA outcomes among children not receiving breastfeeding at baseline vs. those being breastfeed at baseline	4 weeks	Anthropometric, %L and 16s rRNA outcomes (relative abundance, alpha-diversity, beta-diversity) will be compared between study foods among those who are reported to be breastfeeding vs. those who are not
Rate of recovery from moderate acute malnutrition	up to 12 weeks of treatment	Recovery is when a participant reaches a Mid-Upper Arm Circumference of 12.5cm or better
Sub-group analysis of anthropometric outcomes among children with MUAC < 12 cm vs. >= 12 cm at baseline	up to 12 weeks of treatment	Rate of weight change, length change, final MUAC, recovery, SAM, and death will be compared between the study foods among children with baseline MUAC \< vs. \>=12 cm.
Metabolomic feature abundance in the 4 dietary groups	After 4 weeks of supplementary feeding	Metabolomic feature abundance in the 4 dietary groups, as determined by untargeted metabolomics in 200 randomly selected children with MUAC \< 12.1 cm on enrollment

Trial Locations

Locations (1)

Project Peanut Butter Factory; 🇸🇱 Freetown, Sierra Leone