Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition

Summary

The goal of this clinical trial is to test the use of milk fat globule membrane (MFGM) in ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition in Sierra Leone. The main questions it aims to answer are:

* Will the inclusion of MFGM in RUTF for 6-59-month-old Sierra Leonean children with severe acute malnutrition improve their neurodevelopment?
* Will the inclusion of MFGM in RUTF for 6-59-month-old Sierra Leonean children with severe acute malnutrition reduce its worst consequences: death, hospitalization, and remaining severely malnourished despite treatment?

Researchers will compare the MFGM-containing RUTF to standard RUTF, which contains skim milk powder.

Participants will:

* undergo measurement of length, weight, mid-upper arm circumference, and nutritional edema assessment every two weeks during severe malnutrition treatment
* be treated with either MFGM-RUTF or standard RUTF at a dose of 2 sachets per day for up to 12 weeks
* undergo neurodevelopmental testing using the Malawi Developmental Assessment Tool at the end of SAM treatment and 6 months later
* a subset of participants will undergo blood spot collection and stool sample collection

Conditions

• Severe Acute Malnutrition
• Cognitive Impairment
• Kwashiorkor
• Severe Wasting

Interventions

DIETARY_SUPPLEMENT

MFGM-RUTF (milk fat globule membrane ready-to-use therapeutic food)

MFGM whey protein/fat concentrate powder used in place of skim milk powder in peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications. There will be 10g of MFGM-containing whey protein/fat concentrate powder per 100g of MFGM-RUTF. Other ingredients and amounts per 100g: 9.5g rice flour, 5g whey permeate, 18.5g palm oil, 31g peanut paste, 22.1g sugar, 2.9g micronutrient mix, 1g fish oil.

DIETARY_SUPPLEMENT

S-RUTF (standard ready-to-use therapeutic food)

Standard peanut paste-based ready-to-use therapeutic food made with skim milk powder meeting Codex Alimentarius specifications. This RUTF is modeled on the most widely used recipe worldwide, containing per 100g: 19.5g skim milk powder, 9.3g palm oil, 7g canola oil, 31.3g peanut paste, 28g sugar, 1g soy flakes, 1g hydrogenated vegetable oil, and 2.9g micronutrient mix.

DRUG

Amoxicillin

Oral amoxicillin tablets twice per day for 7 days dosed based on weight

DRUG

Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)

Malaria chemoprophylaxis, dosed by weight, to be given every month during SAM treatment

Sponsors & Collaborators

• Project Peanut Butter

  collaborator OTHER

• Ministry of Health and Sanitation, Sierra Leone

  collaborator OTHER_GOV

• Arla Food Ingredients Group P/S

  collaborator UNKNOWN

• The Danish Dairy Research Foundation, Denmark

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Mark J Manary, MD · Washington University School of Medicine

• Kevin B Stephenson, MD · Washington University School of Medicine

• Indi Trehan, MD, MPH · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-22

Primary Completion

2027-12-01

Completion

2027-12-01

Countries

• Sierra Leone

Study Locations