CompletedNCT00812409S-017Updated Jan 17, 2013

Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women

An interventional study of Whey protein supplementation with exercise and Non protein supplementation with exercise (control) in Obesity, sponsored by Purdue University. Completed at 1 site in United States. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-17.

Sponsored by Purdue University · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 580
Allocation: Randomized
Ages: 35 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Obesity

Keywords

Measuring markers of metabolic syndrome in overweight and obese adults.

In context

Lead sponsor

Purdue University is the lead sponsor of 168 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 35 Years to 65 Years
Sexes eligible: 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

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 design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 580 participants (actual)

Study arms

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

Interventions

Dietary supplementWhey protein supplementation with exercise
Whey protein supplementation with resistance and aerobic exercise.
OtherNon protein supplementation with exercise (control)
Non protein supplementation with resistance and aerobic exercise.

What researchers measure

Primary outcomes

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 outcomes

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

Study locations

1 site

Purdue University
West Lafayette, Indiana 47907, United States

References and documents

Publications

Wright CS, McMorrow AM, Weinheimer-Haus EM, Campbell WW. Whey Protein Supplementation and Higher Total Protein Intake Do Not Influence Bone Quantity in Overweight and Obese Adults Following a 36-Week Exercise and Diet Intervention. J Nutr. 2017 Feb;147(2):179-186. doi: 10.3945/jn.116.240473. Epub 2016 Dec 21. PubMed 28003538 ↗
Wright CS, Weinheimer-Haus EM, Fleet JC, Peacock M, Campbell WW. The Apparent Relation between Plasma 25-Hydroxyvitamin D and Insulin Resistance is Largely Attributable to Central Adiposity in Overweight and Obese Adults. J Nutr. 2015 Dec;145(12):2683-9. doi: 10.3945/jn.115.220541. Epub 2015 Oct 7. PubMed 26446485 ↗
Campbell WW, Kim JE, Amankwaah AF, Gordon SL, Weinheimer-Haus EM. Higher Total Protein Intake and Change in Total Protein Intake Affect Body Composition but Not Metabolic Syndrome Indexes in Middle-Aged Overweight and Obese Adults Who Perform Resistance and Aerobic Exercise for 36 Weeks. J Nutr. 2015 Sep;145(9):2076-83. doi: 10.3945/jn.115.213595. Epub 2015 Aug 5. PubMed 26246322 ↗
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. PubMed 22718030 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00812409
Lead sponsor: Purdue University
Responsible party: Wayne Campbell (Wayne Campbell, Ph.D., Purdue University) — Principal investigator
First posted: Dec 22, 2008
Start date: Apr 2007
Primary completion: Jul 2010
Completion: Sep 2010
Last update: Jan 17, 2013

Study contacts

Wayne W Campbell, Ph.D.

principal investigator · Purdue University

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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