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

Sponsored by:	Purdue University
Information provided by:	Purdue University
ClinicalTrials.gov Identifier:	NCT00812409

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:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Exercise and Physical Fitness Obesity

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 ]

Estimated Enrollment:	244
Study Start Date:	April 2007
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental Low protein supplement with resistance and aerobic exercise.	Dietary Supplement: Whey protein supplementation with exercise Whey protein supplementation with resistance and aerobic exercise.
3: Experimental Moderate protein supplement with resistance and aerobic exercise.	Dietary Supplement: Whey protein supplementation with exercise Whey protein supplementation with resistance and aerobic exercise.
4: Experimental 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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812409

Contacts

Contact: Wayne C Campbell, Ph.D.	765-494-8236	campbellw@purdue.edu
Contact: Amy M Kerrigan	765-494-8313	akerriga@purdue.edu

Locations

United States, Indiana
Purdue University	Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Wayne Campbell, Ph.D. 765-494-8236 campbellw@purdue.edu
Contact: Amy M Kerrigan 765-4949-8313 akerriga@purdue.edu

Sponsors and Collaborators

Purdue University

More Information

No publications provided

Responsible Party:	Purdue University ( Wayne Campbell )
Study ID Numbers:	0611004694, 07053552
Study First Received:	December 18, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00812409 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Purdue University:

Measuring markers of metabolic syndrome in overweight and obese adults.

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Whey Protein

Nutrition Disorders
Overnutrition
Overweight

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on August 28, 2009