Clinical Safety of a Novel Milk Protein Peptide

Phase 1

Completed

• Conditions: Drug Safety
• Interventions: Dietary Supplement: Hydrolyzed milk protein mixture; Dietary Supplement: Glycerol placebo

• Registration Number: NCT01412658
• Lead Sponsor: Ambryx Biotechnology

Brief 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.

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2007-01
• Study Completion: 2007-02
• Status Verified: 2011-08
• Study First Submitted: 2011-08-07
• Study First Submitted QC: 2011-08-08
• Last Update Submitted: 2011-08-08
• Study First Posted: 2011-08-09
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Healthy subjects with body mass index between 27-40.

Exclusion Criteria

• have any metabolic disorders including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurologic disease; if they are taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications;
• have milk allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Milk Peptides	Hydrolyzed milk protein mixture	-
Placebo	Glycerol 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.

Primary Outcome Measures

Name	Time	Method
Blood and Hormones	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).

Secondary Outcome Measures

Name	Time	Method
Psychosocial	6 weeks	quality of life indices
Body Composition	6 weeks	All participants were tested for changes in energy intake and body composition

Trial Locations

Locations (1)

Baylor University Center for Exercise, Nutrition, and Preventive Health Research; 🇺🇸 Waco, Texas, United States