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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02190136
Other study ID # Yoga-0610-52
Secondary ID
Status Completed
Phase N/A
First received July 7, 2014
Last updated July 11, 2014
Start date December 2006
Est. completion date July 2014

Study information

Verified date July 2014
Source Skidmore College
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Stretching and flexibility exercise such as yoga and functional resistance exercise are two forms of exercise that are growing in popularity. However, they have not been scientifically tested to demonstrate their ability to improve body composition, fitness, heart and metabolic health, and mood state in overweight/obese women. The investigators hypothesize that during an 11 week intervention, both forms of exercise will improve body composition, heart and metabolic health and mood state.


Description:

This study was a 11 week protein-rich whole food diet and exercise training intervention in middle aged overweight/obese women. Subjects were randomized into 3 groups: Protein-rich whole food only consumed as 20-25 grams per serving 4-6 per day (P); protein and resistance exercise training (R); and protein and stretching/yoga exercise training (S). All outcomes, including the primary outcomes of body composition and cardiometabolic biomarkers were measured at baseline (week 0) and post-intervention (week 12) in all study subjects.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date July 2014
Est. primary completion date January 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 60 Years
Eligibility Inclusion Criteria:

- obese or overweight women

- between ages 25-60 and

- otherwise healthy

Exclusion Criteria:

- smokers,

- habitual exercisers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Protein whole foods
Protein-rich whole foods consumed at 20-30 grams of protein at each of 4-6 meals per day
Protein Resistance Exercise Training
Protein rich whole foods diet and resistance training 3 times per week for 11 weeks
Protein Stretching/Yoga Training
Protein-rich whole foods diet of 20-30 grams of protein at each of 4-6 meals per day with stretching/yoga training 3 times per week for 11 weeks

Locations

Country Name City State
United States Human Nutrition and Metabolism Laboratory Saratoga Springs New York

Sponsors (1)

Lead Sponsor Collaborator
Skidmore College

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Plasma Biomarkers Insulin, glucose, and leptin was assessed in each subject at baseline and 11 weeks baseline and 11 weeks No
Primary Total and Regional Body Composition Total and regional body composition was assessed by dual energy xray absorptiometry (DXA) at baseline and 11 weeks in all subjects baseline and 11 weeks No
Secondary Aerobic Fitness VO2 max was assessed in each subject at baseline and 11 weeks baseline and 11 weeks Yes
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