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
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Condition or disease | Intervention/treatment | Phase |
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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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Control group: non-protein supplement with resistance and aerobic exercise.
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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.
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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.
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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.
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Dietary Supplement: Whey protein supplementation with exercise
Whey protein supplementation with resistance and aerobic exercise. |
- 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 ]
- 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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)

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
United States, Indiana | |
Purdue University | |
West Lafayette, Indiana, United States, 47907 |
Principal Investigator: | Wayne W Campbell, Ph.D. | Purdue University |
Responsible Party: | Wayne Campbell, Wayne Campbell, Ph.D., Purdue University |
ClinicalTrials.gov Identifier: | NCT00812409 |
Other Study ID Numbers: |
0611004694 07053552 |
First Posted: | December 22, 2008 Key Record Dates |
Last Update Posted: | January 17, 2013 |
Last Verified: | January 2013 |
Measuring markers of metabolic syndrome in overweight and obese adults. |