Clinical Safety of a Novel Milk Protein Peptide

Ambryx Biotechnology

Status and phase: Completed; Phase 1

Conditions: Drug Safety

Treatments: Dietary Supplement: Glycerol placebo; Dietary Supplement: Hydrolyzed milk protein mixture

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01412658

AX_Safety_study

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 73 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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73 participants in 2 patient groups, including a placebo group

Milk Peptides

Experimental group

Treatment:

Dietary Supplement: Hydrolyzed milk protein mixture

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Glycerol placebo