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

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ClinicalTrials.gov Identifier: NCT00812409
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : January 17, 2013
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Dietary Supplement: Whey protein supplementation with exercise Other: Non protein supplementation with exercise (control) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women
Study Start Date : April 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

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