Clinical Safety of a Novel Milk Protein Peptide
|ClinicalTrials.gov Identifier: NCT01412658|
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : August 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Drug Safety||Dietary Supplement: Hydrolyzed milk protein mixture Dietary Supplement: Glycerol placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|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|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||February 2007|
|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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|