Clinical trial NCT00812409: Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women
Official title: Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Measuring markers of metabolic syndrome in overweight and obese adults.
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 580
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Influence of resistance and aerobic exercise and whey protein on body weight and body composition (fat mass and fat free mass).
timeFrame: 36 weeks
Secondary outcomes:
measure: 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.
timeFrame: 36 weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne W Campbell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.