Whey Permeate Study
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

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.
    

Intervention name(s): Whey permeate RUSF; Soy Protein RUSF
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MAM