Daily Protein Intake Distribution and MPS (ARCIII)

December 10, 2014 updated by: Nestlé

Effect of Balanced Daily Protein Distribution Supplemented With Whey Protein on Muscle Protein Synthesis in Overweight Older Men During Calorie Restriction and Exercise (ARC III)

To determine whether a balanced total daily dietary protein distribution supplemented with whey protein during a weight-loss intervention will result in increased muscle protein synthesis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Overweight/obese (BMI 27-40 kg/m2)
  • Non-smokers
  • Non-diabetic
  • No history of hyperlipidemia
  • Not taking medications thought to interfere with study
  • Considered generally healthy

Exclusion Criteria:

  • Efforts to lose weight in previous 16 weeks
  • Hyperlipidemia
  • Blood pressure ≥ 140/90 mmHg
  • Smoking
  • Heart and other organ disease
  • Type 2 diabetes
  • Gastrointestinal disease
  • Orthopedic injury interfering with exercise
  • Use of certain medications (HRT, antihypertensives, diuretics, antiarythmia medications, antiresorptive agents, anabolic agents, hypoglycemic agents, and statins known to affect muscle i.e. Simvastatin and Zocor)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: whey protein
whey protein micelles
Other: whey protein
whey protein.
Placebo Comparator: placebo
calorie-free placebo
Other: placebo
placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle protein synthesis
Time Frame: up to 4 weeks
protein synthesis is evaluated in muscle biopsy tissue
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
body composition is evaluated using DEXA
Time Frame: up to 4 weeks
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Stuart Phillips, Ph.D., McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimate)

December 11, 2014

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12.12.NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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