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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

December 18, 2008
January 16, 2013
April 2007
July 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00812409 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women
Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Obesity
  • Dietary Supplement: Whey protein supplementation with exercise
    Whey protein supplementation with resistance and aerobic exercise.
  • Other: Non protein supplementation with exercise (control)
    Non protein supplementation with resistance and aerobic exercise.
  • Experimental: 1
    Control group: non-protein supplement with resistance and aerobic exercise.
    Intervention: Other: Non protein supplementation with exercise (control)
  • Experimental: 2
    Low protein supplement with resistance and aerobic exercise.
    Intervention: Dietary Supplement: Whey protein supplementation with exercise
  • Experimental: 3
    Moderate protein supplement with resistance and aerobic exercise.
    Intervention: Dietary Supplement: Whey protein supplementation with exercise
  • Experimental: 4
    High protein supplement with resistance and aerobic exercise.
    Intervention: Dietary Supplement: Whey protein supplementation with exercise
Weinheimer EM, Conley TB, Kobza VM, Sands LP, Lim E, Janle EM, Campbell WW. Whey protein supplementation does not affect exercise training-induced changes in body composition and indices of metabolic syndrome in middle-aged overweight and obese adults. J Nutr. 2012 Aug;142(8):1532-9. doi: 10.3945/jn.111.153619. Epub 2012 Jun 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
580
September 2010
July 2010   (final data collection date for primary outcome measure)

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)
Both
35 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00812409
0611004694, 07053552
Not Provided
Wayne Campbell, Purdue University
Purdue University
Not Provided
Principal Investigator: Wayne W Campbell, Ph.D. Purdue University
Purdue University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP