Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women - Full Text View

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:

MedlinePlus related topics: Dietary Supplements Exercise and Physical Fitness

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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.

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.

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.


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.

ClinicalTrials.gov processed this record on September 28, 2016

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