NCT01412658

Clinical Safety of a Novel Milk Protein Peptide

Safety Study of Milk Peptide Supplementation in Healthy Volunteers: a Randomized Placebo Controlled Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Ambryx Biotechnology · Industry
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Background: A novel milk peptide has been shown in laboratory setting to have natural anti-cancer properties and extend lifespan and improve metabolism in animal models. The purpose of this study was 1.) to determine the safety dosage range and, 2.) to determine whether this novel milk peptide positively influence blood markers, metabolism and improve quality of life.

Detailed description

The study was conducted as a randomized, double-blind, placebo-controlled clinical trial in a university research setting. Healthy volunteers were randomly assigned to ingest in a double-blind and randomized manner either a placebo or milk peptides. Outcome measures were assessed at 0, 3, and 6 weeks of supplementation.

Conditions

• Drug Safety

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-01-01
• Completion: 2007-02-01
• First posted: 2011-08-09
• Last updated: 2011-08-09

Locations

1 site across 1 country: United States