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

Purdue University

Status: Completed

Conditions: Obesity

Treatments: Other: Non protein supplementation with exercise (control); Dietary Supplement: Whey protein supplementation with exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00812409

07053552

0611004694

Details and patient eligibility

About

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.

Enrollment: 580 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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580 participants in 4 patient groups

1

Experimental group

Description:

Control group: non-protein supplement with resistance and aerobic exercise.

Treatment:

Other: Non protein supplementation with exercise (control)

2

Experimental group

Description:

Low protein supplement with resistance and aerobic exercise.

Treatment:

Dietary Supplement: Whey protein supplementation with exercise

3

Experimental group

Description:

Moderate protein supplement with resistance and aerobic exercise.

Treatment:

Dietary Supplement: Whey protein supplementation with exercise

4

Experimental group

Description:

High protein supplement with resistance and aerobic exercise.

Treatment:

Dietary Supplement: Whey protein supplementation with exercise