Clinical Safety of a Novel Milk Protein Peptide

Drug Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412658
• Other study ID #: AX_Safety_study
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2011
• Last updated: August 8, 2011
• Start date: November 2006
• Est. completion date: February 2007

Study information

• Verified date: August 2011
• Source: Ambryx Biotechnology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Drug Safety

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Baylor University Center for Exercise, Nutrition, and Preventive Health Research	Waco	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Ambryx Biotechnology	Baylor University, Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Psychosocial	quality of life indices	6 weeks	No
Secondary	Body Composition	All participants were tested for changes in energy intake and body composition	6 weeks	No

External Links

•   Exercise & Sport Nutrition Lab