Trial Outcomes & Findings for Whey Permeate Study (NCT NCT01790048)

NCT ID: NCT01790048

Last Updated: 2019-01-17

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2259 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2019-01-17

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	1156	1103
Overall Study COMPLETED	1144	1086
Overall Study NOT COMPLETED	12	17

Reasons for withdrawal

Measure	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	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
Overall Study Incorrect Age	9	14
Overall Study data entry error	0	1
Overall Study Other	0	2
Overall Study SAM at Enrollment	2	0
Overall Study Measurement error	1	0

Baseline Characteristics

Whey Permeate Study

Baseline characteristics by cohort

Measure	Whey Permeate RUSF n=1144 Participants 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	Soy Protein RUSF n=1086 Participants 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 n=2230 Participants Total of all reporting groups
Age, Continuous	16.4 months STANDARD_DEVIATION 9.3 • n=93 Participants	16.5 months STANDARD_DEVIATION 8.9 • n=4 Participants	16.5 months STANDARD_DEVIATION 9.3 • n=27 Participants
Sex: Female, Male Female	688 Participants n=93 Participants	639 Participants n=4 Participants	1327 Participants n=27 Participants
Sex: Female, Male Male	456 Participants n=93 Participants	447 Participants n=4 Participants	903 Participants n=27 Participants
MUAC, cm	12.1 cm STANDARD_DEVIATION .27 • n=93 Participants	12.1 cm STANDARD_DEVIATION .27 • n=4 Participants	12.1 cm STANDARD_DEVIATION 0.27 • n=27 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Whey Permeate RUSF n=1144 Participants 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	Soy Protein RUSF n=1086 Participants 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
Recovery From Moderate Acute Malnutrition (MAM)	960 Participants	874 Participants

SECONDARY outcome

Timeframe: 3 months

Amount of weight gained over the course of treatment

Outcome measures

Measure	Whey Permeate RUSF n=1144 Participants 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	Soy Protein RUSF n=1086 Participants 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
Weight	2.95 Gain (g/kg/day) Standard Deviation 2.04	2.79 Gain (g/kg/day) Standard Deviation 2.16

SECONDARY outcome

Timeframe: 3 months

Amount of height gained over the intervention period.

Outcome measures

Measure	Whey Permeate RUSF n=1144 Participants 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	Soy Protein RUSF n=1086 Participants 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
Height	0.30 mm/d Standard Deviation 0.28	0.29 mm/d Standard Deviation 0.29

SECONDARY outcome

Timeframe: 3 months

Gain in mid-upper arm circumference

Outcome measures

Measure	Whey Permeate RUSF n=1144 Participants 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	Soy Protein RUSF n=1086 Participants 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
Mid-Upper-Arm Circumference (MUAC) Gain	0.26 mm/d Standard Deviation 0.27	0.22 mm/d Standard Deviation 0.28

SECONDARY outcome

Timeframe: 3 months

The amount of time required for a patient to reach recovery

Outcome measures

Measure	Whey Permeate RUSF n=1144 Participants 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	Soy Protein RUSF n=1086 Participants 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
Time to Graduation	29.3 days Standard Deviation 19.0	30.4 days Standard Deviation 20.1

SECONDARY outcome

Timeframe: 3 months

Any adverse events from the supplementary foods reported in the 3 month time frame.

Outcome measures

Measure	Whey Permeate RUSF n=1144 Participants 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	Soy Protein RUSF n=1086 Participants 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
Adverse Events	0 Participants	0 Participants

Adverse Events

Whey Permeate RUSF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Soy Protein RUSF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mark Manary

Washington University School of Medicine in St. Louis

Phone: 314 454 2178

Email: manarymj@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place