Clinical Safety of a Novel Milk Protein Peptide

This study has been completed.
Sponsor:
Collaborators:
Texas A&M University
Baylor University
Information provided by:
Ambryx Biotechnology
ClinicalTrials.gov Identifier:
NCT01412658
First received: August 7, 2011
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Drug Safety
Dietary Supplement: Hydrolyzed milk protein mixture
Dietary Supplement: Glycerol placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Safety Study of Milk Peptide Supplementation in Healthy Volunteers: a Randomized Placebo Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Ambryx Biotechnology:

Primary Outcome Measures:
  • Blood and Hormones [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Psychosocial [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    quality of life indices

  • Body Composition [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    All participants were tested for changes in energy intake and body composition


Enrollment: 73
Study Start Date: November 2006
Study Completion Date: February 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412658

Locations
United States, Texas
Baylor University Center for Exercise, Nutrition, and Preventive Health Research
Waco, Texas, United States, 76706
Sponsors and Collaborators
Ambryx Biotechnology
Texas A&M University
Baylor University
Investigators
Principal Investigator: Rick Kreider, PhD Texas A&M University
  More Information

Additional Information:
No publications provided by Ambryx Biotechnology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard B Kreider, PhD, Texas A&M University
ClinicalTrials.gov Identifier: NCT01412658     History of Changes
Other Study ID Numbers: AX_Safety_study
Study First Received: August 7, 2011
Last Updated: August 8, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 16, 2014