Whey Permeate Study

Comparison of a Novel Ready-to-use Supplementary Food (RUSF) With Whey Permeate to Standard Peanut/Soy RUSF for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomised, Double-blinded, Clinical Effectiveness Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01790048

Enrollment

2259

Registered

2013-02-12

Start date

2013-02-28

Completion date

2015-03-31

Last updated

2019-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

MAM

Brief summary

This is a prospective, randomized, double-blinded, controlled clinical effectiveness trial of two supplementary foods in the treatment of MAM. Specific Aim 1: Test the effectiveness of two supplementary foods, whey RUSF and soy RUSF, in the treatment of MAM in 6-59 month old children in a 12-week home-based supplementary feeding program. Hypothesis: The proportion of children who recover receiving either soy or whey RUSF will differ by no more than three percent.

Detailed description

This will be a randomized, double-blinded, controlled clinical effectiveness trial assessing the treatment of moderate acute malnutrition (MAM) with one of two supplementary foods for a period of up to 12 weeks. The overall purpose of this research is to see if your child will grow and gain weight more rapidly using one of two peanut butter foods as he/she recovers from protein-energy malnutrition. Subjects will be given a soy or dairy peanut butter food at their home. The peanut butter food has either small amounts of soya protein and minerals (iron, zinc) or whey powder and minerals added to them. Subjects will have enough food to feed the child for 2 weeks, and asked to return every 2 weeks to be weighed, measured and given more food. The parents of the subjects will be asked to feed their child this food until his/her weight has returned to what is considered normal for the child's height. Subjects will then return after 3, 6 and 12 months for a check-up. At these check-ups, he/she will be measured and examined. The current standard of care is to allow the child to recover without food or with supplemental flour thus all participation is related to research. Participation in this study is expected to last 8-12 weeks of therapy with follow up in 12 months after completion of the therapy.

Interventions

DIETARY_SUPPLEMENTWhey permeate RUSF

Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted. Whey RUSF contains whey permeate, WPC 80 (contains at least 80% protein), peanut paste, sugar, soy oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier.

DIETARY_SUPPLEMENTSoy Protein RUSF

Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of soy RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted. Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 59 Months

Healthy volunteers

Inclusion criteria

* Children with MAM defined as mid-upper-arm circumference, MUAC, ≤ 12.5 cm and \> 11.5 cm without bipedal edema.

Exclusion criteria

* Children simultaneously involved in another research trial or supplemental feeding program * Children with developmentally delayed * Children with a chronic debilitating illness such as cerebral palsy (not including HIV or TB) * Children with a history of peanut or milk allergy * Children will also be excluded if they had received therapy for acute malnutrition within one month prior to presentation.

Design outcomes

Primary

Measure	Time frame	Description
Recovery From Moderate Acute Malnutrition (MAM)	3 months	The primary outcome measures will be recovery from MAM (achieving MUAC ≥ 12.5 cm by 12 weeks) or failure (death, development of severe acute malnutrition, transfer to hospital for inpatient care, failure to recover from MAM by 12 weeks, default).

Secondary

Measure	Time frame	Description
Weight	3 months	Amount of weight gained over the course of treatment
Height	3 months	Amount of height gained over the intervention period.
Mid-Upper-Arm Circumference (MUAC) Gain	3 months	Gain in mid-upper arm circumference
Time to Graduation	3 months	The amount of time required for a patient to reach recovery
Adverse Events	3 months	Any adverse events from the supplementary foods reported in the 3 month time frame.

Countries

Malawi

Participant flow

Participants by arm

Arm	Count
Whey Permeate RUSF 75 kcal/kg/day (314 k Joules (kJ)/kg/day) of whey RUSF. Whey RUSF contains whey permeate, Whey Permeate (WPC) 80 (contains at least 80% protein), peanut paste, sugar, soy oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier. Whey permeate RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA. Whey permeate RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted. Whey RUSF contains whey permeate, WPC 80 (contains	1,144
Soy Protein RUSF 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources. Soy RUSF will be locally produced and will undergo quality assurance and safety testing for aflatoxin and microbial contamination at the Malawi Bureau of Standards and Eurofins Scientific Inc., Des Moines, Iowa, USA. Soy Protein RUSF: Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of soy RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted. Soy RUSF contains extruded soy	1,086
Total	2,230

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	data entry error	0	1
Overall Study	Incorrect Age	9	14
Overall Study	Measurement error	1	0
Overall Study	Other	0	2
Overall Study	SAM at Enrollment	2	0

Baseline characteristics

Characteristic	Whey Permeate RUSF	Soy Protein RUSF	Total
Age, Continuous	16.4 months STANDARD_DEVIATION 9.3	16.5 months STANDARD_DEVIATION 8.9	16.5 months STANDARD_DEVIATION 9.3
MUAC, cm	12.1 cm STANDARD_DEVIATION 0.27	12.1 cm STANDARD_DEVIATION 0.27	12.1 cm STANDARD_DEVIATION 0.27
Sex: Female, Male Female	688 Participants	639 Participants	1327 Participants
Sex: Female, Male Male	456 Participants	447 Participants	903 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 1,144	0 / 1,086
serious Total, serious adverse events	0 / 1,144	0 / 1,086

Arm	Measure	Value (MEAN)	Dispersion
Whey Permeate RUSF	Weight	2.95 Gain (g/kg/day)	Standard Deviation 2.04
Soy Protein RUSF	Weight	2.79 Gain (g/kg/day)	Standard Deviation 2.16

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026

Whey Permeate Study

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Recovery From Moderate Acute Malnutrition (MAM)

Adverse Events

Height

Mid-Upper-Arm Circumference (MUAC) Gain

Time to Graduation

Weight