Clinical Safety of a Novel Milk Protein Peptide

NCT01412658 | Completed Phase 1 DMC

• 1 other identifier: AX_Safety_study
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Psychosocial

  6 weeks

• Body Composition

  6 weeks

Study Arms (2)

Milk Peptides

EXPERIMENTAL

Dietary Supplement: Hydrolyzed milk protein mixture

Placebo

PLACEBO COMPARATOR

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

Interventions

Hydrolyzed milk protein mixture DIETARY_SUPPLEMENT

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

Also known as: AX-4

Milk Peptides

Glycerol placebo DIETARY_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.

Placebo

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects with body mass index between 27-40.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ambryx Biotechnology: lead
• Texas A&M University: collaborator
• Baylor University: collaborator

Study Sites (1)

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

Waco, Texas, 76706, United States

Location

Related Publications (1)

• Kreider RB, Iosia M, Cooke M, Hudson G, Rasmussen C, Chen H, Mollstedt O, Tsai MH. Bioactive properties and clinical safety of a novel milk protein peptide. Nutr J. 2011 Sep 26;10:99. doi: 10.1186/1475-2891-10-99.

  PMID: 21943352 DERIVED

Related Links

• Exercise \& Sport Nutrition Lab

Study Officials

• Rick Kreider, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 7, 2011
• First Posted: August 9, 2011
• Study Start: November 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: February 1, 2007
• Last Updated: August 9, 2011

Record last verified: 2011-08

Locations

US (1)