Clinical Safety of a Novel Milk Protein Peptide

Ambryx Biotechnology73 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Drug Safety

Interventions

Hydrolyzed milk protein mixtureDIETARY_SUPPLEMENT

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

Glycerol placeboDIETARY_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.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Waco, Texas, United States

Outcomes

Primary Outcomes

Blood and Hormones

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).

Time frame: 6 weeks

Secondary Outcomes

Psychosocial

quality of life indices

Time frame: 6 weeks

Body Composition

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

Time frame: 6 weeks

Data from ClinicalTrials.gov

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