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Clinical Safety of a Novel Milk Protein Peptide

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01412658
First Posted: August 9, 2011
Last Update Posted: August 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Texas A&M University
Baylor University
Information provided by:
Ambryx Biotechnology
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    quality of life indices

  • Body Composition [ Time Frame: 6 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: August 7, 2011
First Posted: August 9, 2011
Last Update Posted: August 9, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs