Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women (S-017)

January 16, 2013 updated by: Wayne Campbell, Purdue University
The purpose of this study is to identify the influence of resistance and aerobic exercise with different nutritional supplements in middle-aged men and women on various physiological measures. Throughout the study, the investigators examine body composition, body weight, food intake, fitness level, metabolism, and blood hormones.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

580

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

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

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men and women age 35-65 yr
  • body weight <300 lbs (136 kg)
  • body mass index between 28 kg/m2 and 35 kg/m2
  • fasting glucose <110 mg/dL
  • blood pressure <160/100 mm Hg
  • plasma total cholesterol <260 mg/dL
  • LDL-cholesterol <160 mg/dL
  • triacylglycerol <400 mg/dL
  • not currently or previously following a weight loss diet or other special/non-balanced diet (in the past 6 months)
  • <1 hour/week of habitual aerobic exercise training and no resistance
  • exercise training (in the past 6 months)

Exclusion Criteria:

  • men and women age < 35 yr or >65 yr
  • body weight >300 lbs (136 kg)
  • body mass index between <28 kg/m2 or >35 kg/m2
  • fasting glucose >110 mg/dL
  • blood pressure >160/100 mm Hg
  • plasma total cholesterol >260 mg/dL
  • LDL-cholesterol >160 mg/dL
  • triacylglycerol >400 mg/dL
  • currently or previously following a weight loss diet or other special/non- balanced diet (in the past 6 months)

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Control group: non-protein supplement with resistance and aerobic exercise.
Other: Non protein supplementation with exercise (control)
Non protein supplementation with resistance and aerobic exercise.
Experimental: 2
Low protein supplement with resistance and aerobic exercise.
Dietary supplement: Whey protein supplementation with exercise
Whey protein supplementation with resistance and aerobic exercise.
Experimental: 3
Moderate protein supplement with resistance and aerobic exercise.
Dietary supplement: Whey protein supplementation with exercise
Whey protein supplementation with resistance and aerobic exercise.
Experimental: 4
High protein supplement with resistance and aerobic exercise.
Dietary supplement: Whey protein supplementation with exercise
Whey protein supplementation with resistance and aerobic exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Influence of resistance and aerobic exercise and whey protein on body weight and body composition (fat mass and fat free mass).
Time Frame: 36 weeks
36 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Influence of resistance and aerobic exercise and whey protein on dietary and macronutrient intakes, insulin-mediated glucose metabolism, physical fitness and markers of metabolic and cardiovascular health.
Time Frame: 36 weeks
36 weeks

Collaborators and Investigators

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

Sponsor

Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2007

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0611004694
  • 07053552

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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