Clinical Safety of a Novel Milk Protein Peptide

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Drug Safety

Intervention / Treatment
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* Dietary Supplement: Hydrolyzed milk protein mixture
* Dietary Supplement: Glycerol placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milk Peptides<br> | Dietary Supplement: Hydrolyzed milk protein mixture<br>* Take twice a day, dosage 6 ml-21 ml based on weight, mix with 1/2 cup of milk.<br>* Other names: AX-4;|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial | quality of life indices | 6 weeks | 
| Body Composition | All participants were tested for changes in energy intake and body composition | 6 weeks |