Clinical Safety of a Novel Milk Protein Peptide

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

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.

Study Overview

• Status: Completed
• Conditions: Drug Safety
• Intervention / Treatment: Dietary supplement: Hydrolyzed milk protein mixture; Dietary supplement: Glycerol placebo

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Waco, Texas, United States, 76706
      • Baylor University Center for Exercise, Nutrition, and Preventive Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood and Hormones	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).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychosocial	quality of life indices	6 weeks
Body Composition	All participants were tested for changes in energy intake and body composition	6 weeks

Collaborators and Investigators

• Sponsor: Ambryx Biotechnology
• Collaborators: Texas A&M University; Baylor University
• Investigators: Principal Investigator: Rick Kreider, PhD, Texas A&M University

Publications and helpful links

General Publications

• Kreider RB, Iosia M, Cooke M, Hudson G, Rasmussen C, Chen H, Mollstedt O, Tsai MH. Bioactive properties and clinical safety of a novel milk protein peptide. Nutr J. 2011 Sep 26;10:99. doi: 10.1186/1475-2891-10-99.

Helpful Links

• Exercise & Sport Nutrition Lab

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: August 7, 2011
• First Submitted That Met QC Criteria: August 8, 2011
• First Posted (Estimate): August 9, 2011

Study Record Updates

• Last Update Posted (Estimate): August 9, 2011
• Last Update Submitted That Met QC Criteria: August 8, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Chelating Agents; Sequestering Agents; Cryoprotective Agents; Glycerol; Caseins
• Other Study ID Numbers: AX_Safety_study