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

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT04216043
• Collaborator: Project Peanut Butter, Sierra Leone (Other)
• Enrollment: 1,102
• Location: 1
• Arms: 4
• Actual Duration (Months): 17.6
• Patients Per Site Per Month: 62.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malnutrition, Child	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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?
• Actual Study Start Date: Sep 16, 2020
• Actual Primary Completion Date: Mar 7, 2022
• Actual Study Completion Date: Mar 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: RUSF skimmed milk powder; ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
Experimental: 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.	Dietary Supplement: RUSF milk protein concentrate and sucrose; ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
Experimental: 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.	Dietary Supplement: RUSF soy protein and whey permeate; ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
Experimental: 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.	Dietary Supplement: RUSF soy and sucrose; ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients

Outcome Measures

Primary Outcome Measures

1. % 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)

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

1. Rate of weight gain (g/kg/d) [up to 12 weeks of treatment]

   Changes in weight relative to baseline weight

2. Rate of length gain (mm/week) [up to 12 weeks of treatment]

   Changes in linear growth

3. Final mid-upper arm circumference [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 [4 weeks]

   Percentage of children with %L excreted < 0.20

5. 16S rRNA beta-diversity at week 4 [4 weeks]

   Looking at the 16S configuration in stool samples collected

6. 16S rRNA alpha-diversity at week 4 [4 weeks]

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

7. 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

8. 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

9. Sub-group analysis of %L and 16S rRNA outcomes among children not receiving breastfeeding at baseline vs. those being breastfeed at baseline [4 weeks]

   o 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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 59 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Project Peanut Butter Factory	Freetown		Sierra Leone

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Mark Manary, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.
• Caulfield LE, de Onis M, Blössner 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.
• 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.
• 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.
• Shankar AH. Nutritional modulation of malaria morbidity and mortality. J Infect Dis. 2000 Sep;182 Suppl 1:S37-53. Review.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT04216043
• Other Study ID Numbers: 201912091
• First Posted: Jan 2, 2020
• Last Update Posted: May 27, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Malnutrition; Child Nutrition Disorders; Caseins

Study Results

No Results Posted as of May 27, 2022