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

NCT04216043 | Completed

• 1 other identifier: 201912091
• Study Type: interventional
• Target: 1,102
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition, Child

Outcome Measures

Primary Outcomes (2)

• % lactulose excretion after 4 weeks of supplementary feeding

  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)

  4 weeks

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

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

  4 weeks

Secondary Outcomes (11)

• Rate of weight gain (g/kg/d)

  up to 12 weeks of treatment

• Rate of length gain (mm/week)

  up to 12 weeks of treatment

• Final mid-upper arm circumference

  up to 12 weeks of treatment

• Proportion with %L < 0.20

  4 weeks

• 16S rRNA beta-diversity at week 4

  4 weeks

Study Arms (4)

RUSF skimmed milk powder

EXPERIMENTAL

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.

Dietary Supplement: RUSF skimmed milk powder

RUSF milk protein concentrate and sucrose

EXPERIMENTAL

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.

Dietary Supplement: RUSF milk protein concentrate and sucrose

RUSF soy protein and whey permeate

EXPERIMENTAL

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.

Dietary Supplement: RUSF soy protein and whey permeate

RUSF soy and sucrose

EXPERIMENTAL

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.

Dietary Supplement: RUSF soy and sucrose

Interventions

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 skimmed milk powder

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 milk protein concentrate and sucrose

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 protein and whey permeate

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

RUSF soy and sucrose

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Project Peanut Butter, Sierra Leone: collaborator

Study Sites (1)

Project Peanut Butter Factory

Freetown, Sierra Leone

Location

Related Publications (6)

• Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.

  PMID: 18207566 BACKGROUND

• Caulfield LE, de Onis M, Blossner M, Black RE. Undernutrition as an underlying cause of child deaths associated with diarrhea, pneumonia, malaria, and measles. Am J Clin Nutr. 2004 Jul;80(1):193-8. doi: 10.1093/ajcn/80.1.193.

  PMID: 15213048 BACKGROUND

• Shankar AH. Nutritional modulation of malaria morbidity and mortality. J Infect Dis. 2000 Sep;182 Suppl 1:S37-53. doi: 10.1086/315906.

  PMID: 10944483 BACKGROUND

• Matilsky DK, Maleta K, Castleman T, Manary MJ. Supplementary feeding with fortified spreads results in higher recovery rates than with a corn/soy blend in moderately wasted children. J Nutr. 2009 Apr;139(4):773-8. doi: 10.3945/jn.108.104018. Epub 2009 Feb 18.

  PMID: 19225128 BACKGROUND

• Nackers F, Broillet F, Oumarou D, Djibo A, Gaboulaud V, Guerin PJ, Rusch B, Grais RF, Captier V. Effectiveness of ready-to-use therapeutic food compared to a corn/soy-blend-based pre-mix for the treatment of childhood moderate acute malnutrition in Niger. J Trop Pediatr. 2010 Dec;56(6):407-13. doi: 10.1093/tropej/fmq019. Epub 2010 Mar 23.

  PMID: 20332221 BACKGROUND

• Son M, Laury ML, Stephenson KB, May T, Hendrixson DT, Koroma AS, Ngegbai AS, Song JH, Naskidashvili N, Goo YA, Manary MJ. The Impact of Milk on Gut Permeability, Fecal 16S rRNA Gene Microbiota Profiling, and Fecal Metabolomics in Children with Moderate Malnutrition in Sierra Leone: A Double-Blind, Randomized Controlled Trial. Am J Clin Nutr. 2024 Nov;120(5):1114-1124. doi: 10.1016/j.ajcnut.2024.09.018. Epub 2024 Sep 21.

  PMID: 39307188 DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Mark Manary, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The RUSF food products are very similar in appearance and texture; thus, subjects and caretakers will be blinded. The investigators making the clinical assessments will not have information as to specialized food product assignment of the subject, and will remain blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 2, 2020
• Study Start: September 16, 2020
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

SI (1)