Back to resultsYoga Improves Aerobic Fitness, Glycemia and Mood State and Reduces Abdominal Obesity (PRISE)
Primary Purpose
Obesity, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein whole foods
Protein Resistance Exercise Training
Protein Stretching/Yoga Training
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring obesity, protein-rich whole foods diet, aerobic fitness, resistance training, stretching/yoga training, glycemia, mood state
Eligibility Criteria
Inclusion Criteria:
- obese or overweight women
- between ages 25-60 and
- otherwise healthy
Exclusion Criteria:
- smokers,
- habitual exercisers
Sites / Locations
- Human Nutrition and Metabolism Laboratory
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Protein whole foods
Protein Resistance Exercise Training
Protein Stretching/Yoga Training
Arm Description
Ingestion of 20-25 grams per serving consumed 4-6 times per day; 1 within an hour of waking in the morning and the other 2.5-3 hours apart during the day.
Ingestion of 4-6 protein-rich meals per day and 3 times per week of resistance functional training.
Ingestion of Protein-rich diet 4-6 meals/day and stretching/yoga training 3 times per week
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Aerobic Fitness
VO2 max was assessed in each subject at baseline and 11 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02190136
Brief Title
Yoga Improves Aerobic Fitness, Glycemia and Mood State and Reduces Abdominal Obesity
Acronym
PRISE
Official Title
Yoga Improves Aerobic Fitness, Glycemia and Mood State and Reduces Abdominal Obesity in Overweight Women: The PRISE Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skidmore College
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
Keywords
obesity, protein-rich whole foods diet, aerobic fitness, resistance training, stretching/yoga training, glycemia, mood state
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protein whole foods
Arm Type
Active Comparator
Arm Description
Ingestion of 20-25 grams per serving consumed 4-6 times per day; 1 within an hour of waking in the morning and the other 2.5-3 hours apart during the day.
Arm Title
Protein Resistance Exercise Training
Arm Type
Experimental
Arm Description
Ingestion of 4-6 protein-rich meals per day and 3 times per week of resistance functional training.
Arm Title
Protein Stretching/Yoga Training
Arm Type
Experimental
Arm Description
Ingestion of Protein-rich diet 4-6 meals/day and stretching/yoga training 3 times per week
Intervention Type
Other
Intervention Name(s)
Protein whole foods
Intervention Description
Protein-rich whole foods consumed at 20-30 grams of protein at each of 4-6 meals per day
Intervention Type
Other
Intervention Name(s)
Protein Resistance Exercise Training
Intervention Description
Protein rich whole foods diet and resistance training 3 times per week for 11 weeks
Intervention Type
Other
Intervention Name(s)
Protein Stretching/Yoga Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Total and Regional Body Composition
Description
Total and regional body composition was assessed by dual energy xray absorptiometry (DXA) at baseline and 11 weeks in all subjects
Time Frame
baseline and 11 weeks
Secondary Outcome Measure Information:
Title
Aerobic Fitness
Description
VO2 max was assessed in each subject at baseline and 11 weeks
Time Frame
baseline and 11 weeks
Other Pre-specified Outcome Measures:
Title
Plasma Biomarkers
Description
Insulin, glucose, and leptin was assessed in each subject at baseline and 11 weeks
Time Frame
baseline and 11 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
obese or overweight women
between ages 25-60 and
otherwise healthy
Exclusion Criteria:
smokers,
habitual exercisers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Arciero, PhD
Organizational Affiliation
Skidmore College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Nutrition and Metabolism Laboratory
City
Saratoga Springs
State/Province
New York
ZIP/Postal Code
12866
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26901102
Citation
Ruby M, Repka CP, Arciero PJ. Comparison of Protein-Pacing Alone or With Yoga/Stretching and Resistance Training on Glycemia, Total and Regional Body Composition, and Aerobic Fitness in Overweight Women. J Phys Act Health. 2016 Jul;13(7):754-64. doi: 10.1123/jpah.2015-0493. Epub 2016 Feb 19.
Results Reference
derived
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Yoga Improves Aerobic Fitness, Glycemia and Mood State and Reduces Abdominal Obesity
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