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


Phase 1
35 Years
60 Years
Not Enrolling
Both
Drug Safety

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Trial Information

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


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.


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

Type of Study:

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

Outcome Measure:

Blood and Hormones

Outcome Description:

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).

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Rick Kreider, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Texas A&M University

Authority:

United States: Institutional Review Board

Study ID:

AX_Safety_study

NCT ID:

NCT01412658

Start Date:

November 2006

Completion Date:

February 2007

Related Keywords:

  • Drug Safety

Name

Location
Baylor University Center for Exercise, Nutrition, and Preventive Health Research Waco, Texas  76706