Clinical Safety of a Novel Milk Protein Peptide
|Drug Safety||Dietary Supplement: Hydrolyzed milk protein mixture Dietary Supplement: Glycerol placebo||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Safety Study of Milk Peptide Supplementation in Healthy Volunteers: a Randomized Placebo Controlled Clinical Trial|
- Blood and Hormones [ Time Frame: 6 weeks ]General whole blood and serum clinical chemistries (cholesterol, triglycerides, glucose, blood urea nitrogen, creatinine, uric acid, muscle and liver enzymes) and hormones (insulin, homeostasis model of insulin sensitivity, and leptin).
- Psychosocial [ Time Frame: 6 weeks ]quality of life indices
- Body Composition [ Time Frame: 6 weeks ]All participants were tested for changes in energy intake and body composition
|Study Start Date:||November 2006|
|Study Completion Date:||February 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
|Experimental: Milk Peptides||
Dietary Supplement: Hydrolyzed milk protein mixture
Take twice a day, dosage 6 ml-21 ml based on weight, mix with 1/2 cup of milk.
Other Name: AX-4
Placebo Comparator: Placebo
Participants ingested 6ml - 21ml (based on participants' weight) of clear, sugar-less liquid placebo mixed with 1/2 cup milk twice daily (once immediately after breakfast and once immediately after dinner). The supplements were prepared in liquid form and packaged in generic bottles for double blind administration. The placebo was a glycerol-based placebo matched for color, texture, and taste to the active supplement.
Dietary Supplement: Glycerol placebo
Participants ingested 6ml-21ml of placebo mixed with 1/2 cup milk twice daily. The supplements were prepared in liquid form and packaged in generic bottles for double blind administration. The placebo was a starch-based placebo matched for color, texture, and taste to the active supplement.
A food diary is maintained daily.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412658
|United States, Texas|
|Baylor University Center for Exercise, Nutrition, and Preventive Health Research|
|Waco, Texas, United States, 76706|
|Principal Investigator:||Rick Kreider, PhD||Texas A&M University|