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Whey Permeate Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01790048
Recruitment Status : Completed
First Posted : February 12, 2013
Results First Posted : January 17, 2019
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Malnutrition
Interventions Dietary Supplement: Whey permeate RUSF
Dietary Supplement: Soy Protein RUSF
Enrollment 2259
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Whey Permeate RUSF Soy Protein RUSF
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 1156 1103
Completed 1144 1086
Not Completed 12 17
Reason Not Completed
Incorrect Age             9             14
data entry error             0             1
Other             0             2
SAM at Enrollment             2             0
Measurement error             1             0
Arm/Group Title Whey Permeate RUSF Soy Protein RUSF Total
Hide Arm/Group Description

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

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

Total of all reporting groups
Overall Number of Baseline Participants 1144 1086 2230
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Months
Number Analyzed 1144 participants 1086 participants 2230 participants
16.4  (9.3) 16.5  (8.9) 16.5  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1144 participants 1086 participants 2230 participants
Female
688
  60.1%
639
  58.8%
1327
  59.5%
Male
456
  39.9%
447
  41.2%
903
  40.5%
MUAC, cm  
Median (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 1144 participants 1086 participants 2230 participants
12.1  (.27) 12.1  (.27) 12.1  (0.27)
1.Primary Outcome
Title Recovery From Moderate Acute Malnutrition (MAM)
Hide Description 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).
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whey Permeate RUSF Soy Protein RUSF
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 1144 1086
Measure Type: Count of Participants
Unit of Measure: Participants
960
  83.9%
874
  80.5%
2.Secondary Outcome
Title Weight
Hide Description Amount of weight gained over the course of treatment
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whey Permeate RUSF Soy Protein RUSF
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 1144 1086
Mean (Standard Deviation)
Unit of Measure: Gain (g/kg/day)
2.95  (2.04) 2.79  (2.16)
3.Secondary Outcome
Title Height
Hide Description Amount of height gained over the intervention period.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whey Permeate RUSF Soy Protein RUSF
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 1144 1086
Mean (Standard Deviation)
Unit of Measure: mm/d
0.30  (0.28) 0.29  (0.29)
4.Secondary Outcome
Title Mid-Upper-Arm Circumference (MUAC) Gain
Hide Description Gain in mid-upper arm circumference
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whey Permeate RUSF Soy Protein RUSF
Hide Arm/Group Description:

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 at

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 (314kJ/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 flo

Overall Number of Participants Analyzed 1144 1086
Mean (Standard Deviation)
Unit of Measure: mm/d
0.26  (0.27) 0.22  (0.28)
5.Secondary Outcome
Title Time to Graduation
Hide Description The amount of time required for a patient to reach recovery
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whey Permeate RUSF Soy Protein RUSF
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 1144 1086
Mean (Standard Deviation)
Unit of Measure: days
29.3  (19.0) 30.4  (20.1)
6.Secondary Outcome
Title Adverse Events
Hide Description Any adverse events from the supplementary foods reported in the 3 month time frame.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whey Permeate RUSF Soy Protein RUSF
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 1144 1086
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Whey Permeate RUSF Soy Protein RUSF
Hide Arm/Group Description

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

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 f

All-Cause Mortality
Whey Permeate RUSF Soy Protein RUSF
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Whey Permeate RUSF Soy Protein RUSF
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1144 (0.00%)   0/1086 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Whey Permeate RUSF Soy Protein RUSF
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1144 (0.00%)   0/1086 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Mark Manary
Organization: Washington University School of Medicine in St. Louis
Phone: 314 454 2178
Other Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01790048     History of Changes
Other Study ID Numbers: 201211066
First Submitted: February 8, 2013
First Posted: February 12, 2013
Results First Submitted: July 31, 2018
Results First Posted: January 17, 2019
Last Update Posted: January 17, 2019