Clinical Safety of a Novel Milk Protein Peptide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioactive Milk Peptides and Blood Pressure

NCT01031485

Stage 1 Hypertension

COMPLETED PHASE3

Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding

NCT06701604

Amino Acid Absorption Probiotic

NOT_YET_RECRUITING NA

Clinical Trial of Dietary Protein and Blood Pressure

NCT00046566

Cardiovascular Diseases Hypertension Heart Diseases

COMPLETED NA

Soy Protein and Breast Cancer Risk Reduction

NCT00204477

Breast Cancer

COMPLETED PHASE2

Effects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults

NCT01692860

Sarcopenia Metabolic Disease High Blood Pressure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Drug Safety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Milk Peptides

Group Type EXPERIMENTAL

Hydrolyzed milk protein mixture

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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.

Group Type PLACEBO_COMPARATOR

Glycerol placebo

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hydrolyzed milk protein mixture

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

Intervention Type DIETARY_SUPPLEMENT

Glycerol placebo

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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AX-4

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes