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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier:
NCT00812409
First received: December 18, 2008
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Dietary Supplement: Whey protein supplementation with exercise
Other: Non protein supplementation with exercise (control)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Purdue University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 580
Study Start Date: April 2007
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812409

Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Investigators
Principal Investigator: Wayne W Campbell, Ph.D. Purdue University
  More Information

No publications provided by Purdue University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wayne Campbell, Wayne Campbell, Ph.D., Purdue University
ClinicalTrials.gov Identifier: NCT00812409     History of Changes
Other Study ID Numbers: 0611004694, 07053552
Study First Received: December 18, 2008
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
Measuring markers of metabolic syndrome in overweight and obese adults.

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013