ObesityPRISENCT02190136
Yoga Improves Aerobic Fitness, Glycemia and Mood State and Reduces Abdominal Obesity
A study testing Protein whole foods, Protein Resistance Exercise Training and Protein Stretching/Yoga Training in people with Obesity and Insulin Resistance, run by Skidmore College at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Protein whole foods, Protein Resistance Exercise Training and Protein Stretching/Yoga Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- obese or overweight women
- between ages 25-60 and
- otherwise healthy
Who cannot join
- smokers,
- habitual exercisers
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Nutrition and Metabolism Laboratory
Saratoga Springs, New York, 12866
About this study
Official title: Yoga Improves Aerobic Fitness, Glycemia and Mood State and Reduces Abdominal Obesity in Overweight Women: The PRISE Study
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.
Read the 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.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Protein whole foods, Protein Resistance Exercise Training, Protein Stretching/Yoga Training
- Keywords
- obesity, protein-rich whole foods diet, aerobic fitness, resistance training, stretching/yoga training, glycemia, mood state
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein whole foodsOther
Protein-rich whole foods consumed at 20-30 grams of protein at each of 4-6 meals per day
Protein Resistance Exercise TrainingOther
Protein rich whole foods diet and resistance training 3 times per week for 11 weeks
Protein Stretching/Yoga TrainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Protein whole foods | Active comparator | 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. Receives: Other: Protein whole foods; Other: Protein Resistance Exercise Training; Other: Protein Stretching/Yoga Training |
| Protein Resistance Exercise Training | Experimental | Ingestion of 4-6 protein-rich meals per day and 3 times per week of resistance functional training. Receives: Other: Protein whole foods; Other: Protein Resistance Exercise Training |
| Protein Stretching/Yoga Training | Experimental | Ingestion of Protein-rich diet 4-6 meals/day and stretching/yoga training 3 times per week Receives: Other: Protein whole foods; Other: Protein Stretching/Yoga Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 11 weeks
Secondary outcomes (1)
Aerobic Fitness
VO2 max was assessed in each subject at baseline and 11 weeks
Measured: baseline and 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startDec 2006
- Primary completionJan 2008
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skidmore College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Arciero, Skidmore College
- Investigators
- Paul J Arciero, PhD, Principal investigator, Skidmore College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190136
- Sponsor's protocol ID
- Yoga-0610-52
- Acronym
- PRISE
- Status last verified
- Jul 2014
- First submitted
- 7 Jul 2014
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26901102
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga Improves Aerobic Fitness, Glycemia and Mood State and Reduces Abdominal Obesity in Overweight Women: The PRISE Study
- ClinicalTrials.gov ID
- NCT02190136
- Acronym / sponsor ID
- PRISE / Yoga-0610-52
- Conditions
- Obesity, Insulin Resistance
- Keywords
- obesity, protein-rich whole foods diet, aerobic fitness, resistance training, stretching/yoga training, glycemia, mood state
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Skidmore CollegeUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Protein whole foods | Active comparator | Other: Protein whole foods, Other: Protein Resistance Exercise Training, Other: Protein Stretching/Yoga TrainingIngestion 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. |
| Protein Resistance Exercise Training | Experimental | Other: Protein whole foods, Other: Protein Resistance Exercise TrainingIngestion of 4-6 protein-rich meals per day and 3 times per week of resistance functional training. |
| Protein Stretching/Yoga Training | Experimental | Other: Protein whole foods, Other: Protein Stretching/Yoga TrainingIngestion of Protein-rich diet 4-6 meals/day and stretching/yoga training 3 times per week |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- obese or overweight women
- between ages 25-60 and
- otherwise healthy
Key exclusion criteria (2 listed)
- smokers,
- habitual exercisers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein whole foodsProtein-rich whole foods consumed at 20-30 grams of protein at each of 4-6 meals per day | Other | Protein Resistance Exercise Training, Protein Stretching/Yoga Training, Protein whole foods |
| Protein Resistance Exercise TrainingProtein rich whole foods diet and resistance training 3 times per week for 11 weeks | Other | Protein Resistance Exercise Training, Protein whole foods |
| Protein Stretching/Yoga TrainingProtein-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 | Other | Protein Stretching/Yoga Training, Protein whole foods |
Primary outcome
Total and Regional Body Composition
Time frame: baseline and 11 weeks
Total and regional body composition was assessed by dual energy xray absorptiometry (DXA) at baseline and 11 weeks in all subjects
1 secondary outcome
Aerobic Fitness
Time frame: baseline and 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
- Derived from this study: PubMed 26901102Ruby 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Arciero, PhD principal investigator
Skidmore College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein whole foods, Protein Resistance Exercise Training and Protein Stretching/Yoga Training in people with Obesity and Insulin Resistance, run by Skidmore College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total and Regional Body Composition (time frame: baseline and 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02190136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.