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Clinical Safety of a Novel Milk Protein Peptide

NCT01412658 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2011-08-09

No results posted yet for this study

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.

Conditions

  • Drug Safety

Interventions

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.

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.

Sponsors & Collaborators

  • Texas A&M University

    collaborator OTHER

  • Baylor University

    collaborator OTHER

  • Ambryx Biotechnology

    lead INDUSTRY

Principal Investigators

  • Rick Kreider, PhD · Texas A&M University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-01-31
Completion
2007-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01412658 on ClinicalTrials.gov