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OpenTrials
Completed

NCT Number: NCT01412658

Clinical Safety of a Novel Milk Protein Peptide

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.

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Key information

Conditions

Drug Safety

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Baylor University Center for Exercise, Nutrition, and Preventive Health Research

Waco, Texas, 76706, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrolyzed milk protein mixture

Dietary Supplement

Take twice a day, dosage 6 ml-21 ml based on weight, mix with 1/2 cup of milk.

Other names: AX-4

Glycerol placebo

Dietary Supplement

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.

Primary outcomes

  1. 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 outcomes

  1. Psychosocial

    Time frame: 6 weeks

    quality of life indices

  2. Body Composition

    Time frame: 6 weeks

    All participants were tested for changes in energy intake and body composition

Sponsors and collaborators

Lead sponsor

Ambryx Biotechnology

Industry

Collaborators

  • Baylor University
  • Texas A&M University

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 9, 2011
Registry last updated
Aug 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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