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Completed

NCT Number: NCT04216043

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

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.

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Key information

Conditions

Malnutrition, Child Child Nutrition Disorders Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Project Peanut Butter Factory

Freetown, Sierra Leone

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

RUSF skimmed milk powder

Dietary Supplement

ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients

RUSF milk protein concentrate and sucrose

Dietary Supplement

ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients

RUSF soy protein and whey permeate

Dietary Supplement

ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients

RUSF soy and sucrose

Dietary Supplement

ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients

Primary outcomes

  1. % lactulose excretion after 4 weeks of supplementary feeding

    Time frame: 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)

  2. 16S rRNA relative abundance of bacterial taxa after 4 weeks of supplementary feeding

    Time frame: 4 weeks

    This will only be assessed in children with higher-risk (MUAC < 12 cm) MAM at baseline

Secondary outcomes

  1. Rate of weight gain (g/kg/d)

    Time frame: up to 12 weeks of treatment

    Changes in weight relative to baseline weight

  2. Rate of length gain (mm/week)

    Time frame: up to 12 weeks of treatment

    Changes in linear growth

  3. Final mid-upper arm circumference

    Time frame: up to 12 weeks of treatment

    Use the mid-upper are circumference at the visit when outcome was reached

  4. Proportion with %L < 0.20

    Time frame: 4 weeks

    Percentage of children with %L excreted < 0.20

  5. 16S rRNA beta-diversity at week 4

    Time frame: 4 weeks

    Looking at the 16S configuration in stool samples collected

  6. 16S rRNA alpha-diversity at week 4

    Time frame: 4 weeks

    Several metrics of alpha diversity will be assessed, including Shannon's index

  7. Rate of recovery from moderate acute malnutrition

    Time frame: up to 12 weeks of treatment

    Recovery is when a participant reaches a Mid-Upper Arm Circumference of 12.5cm or better

  8. Rate of deteriorating to severe acute malnutrition or death

    Time frame: up to 12 weeks of treatment

    Severe acute malnutrition defined by MUAC < 11.5 cm or development of nutritional edema

  9. Sub-group analysis of %L and 16S rRNA outcomes among children not receiving breastfeeding at baseline vs. those being breastfeed at baseline

    Time frame: 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

  10. Sub-group analysis of anthropometric outcomes among children with MUAC < 12 cm vs. >= 12 cm at baseline

    Time frame: 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.

  11. Metabolomic feature abundance in the 4 dietary groups

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Project Peanut Butter, Sierra Leone

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 2, 2020
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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