Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women

Study Overview
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Brief Summary
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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.

Official Title
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Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Whey protein supplementation with exercise
* Other: Non protein supplementation with exercise (control)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Control group: non-protein supplement with resistance and aerobic exercise. | Other: Non protein supplementation with exercise (control)<br>* Non protein supplementation with resistance and aerobic exercise.<br>|
| Experimental: 2<br>Low protein supplement with resistance and aerobic exercise. | Dietary Supplement: Whey protein supplementation with exercise<br>* Whey protein supplementation with resistance and aerobic exercise.<br>|
| Experimental: 3<br>Moderate protein supplement with resistance and aerobic exercise. | Dietary Supplement: Whey protein supplementation with exercise<br>* Whey protein supplementation with resistance and aerobic exercise.<br>|
| Experimental: 4<br>High protein supplement with resistance and aerobic exercise. | Dietary Supplement: Whey protein supplementation with exercise<br>* Whey protein supplementation with resistance and aerobic exercise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of resistance and aerobic exercise and whey protein on body weight and body composition (fat mass and fat free mass). |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Measuring markers of metabolic syndrome in overweight and obese adults.