Metabolic SyndromeDIVAS2NCT01977885
Exercise-Induced Epigenetic Modifications in Obese Aging Women
A study testing High Protein Diet and Exercise in people with Metabolic Syndrome, run by University of Georgia at 1 site in United States.
Trial summary
Our greatest public health challenge is obesity and the co-morbidities of metabolic syndrome (MetS). Age is an established risk factor for MetS and specific to women, data indicates that the prevalence of MetS increases substantially with the menopausal transition with postmenopausal women having a 60% increased risk… Read more about this study
- Who is it for?
- Ages 50 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- High Protein Diet and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 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 50 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer for the study
- Age between 50 and 64 years
- Self-identified as White or Caucasian
- Postmenopausal
- Sedentary (less than 1 hour each week of planned physical activity and sedentary job)
- BMI range >/= 25 kg/m2
Show all 12Show fewer
- Waist circumference >88cm
- Weight stable (within 2 kg) for 6 months
- All allowable medications stable for 3 months
- Live independently
- Willing and able to obtain transportation to and from lab sessions
- Obtains physician clearance to participate in the study
Who cannot join
- Tobacco use
- Normal weight (BMI < 25 kg/m2)
- Males
- Dietary restrictions that do not allow for the consumption of beef, as required by our dietary protocol
- Weight loss surgery and/or weight loss medications usage
- Mini-mental state exam score < 25
Show all 13Show fewer
- Recent or history of unstable CVD
- Cancer treatment within the last 5 years or active cancer
- History of lung disease or COPD or severe asthma
- History or severe arthritis or other medical condition that precludes ability to exercise to level needed by study.
- Current diagnosis or history of balance disorders
- History of mental disorders, dementia, clinical depression or other disorders that preclude adherence to protocols.
- Current weight of 350 pounds or greater, due to weight restrictions on equipment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Body Composition and Metabolism Lab, UGA, Ramsey Student Center
Athens, Georgia, 30602
About this study
Our greatest public health challenge is obesity and the co-morbidities of metabolic syndrome (MetS). Age is an established risk factor for MetS and specific to women, data indicates that the prevalence of MetS increases substantially with the menopausal transition with postmenopausal women having a 60% increased risk of MetS. Menopause also contributes to reductions in strength, physical function and often psychological well-being (e.g. fatigue). Obese individuals also have: a) impaired immune function and chronic inflammatory responses associated with changes in the white blood cell population in blood and fat tissues; and, b) increased secretion of and signaling by proteins in their fat cells. Weight loss, which requires an energy deficit through increased physical activity and/or caloric restriction (EX+CR), reduces risk for MetS in older sedentary obese women by reducing insulin resistance and chronic systemic inflammation. Science and clinical practice will be advanced by examining the molecular mechanisms by which EX+CR affects risk for MetS in older women. The primary aim is to determine if CD4+ T cells will report the differential epigenetic reprogramming of relevant gene expression associated with metabolic indices resulting from EX+CR induced weight loss in older women known to be at risk for MetS. This pilot data will be used to generate an NIH proposal of the same topic. A secondary aim is to assess the impact of weight loss on physical function and psychological well-being which will provide pilot data for an additional grant proposal regarding weight management in postmenopausal women.
- Conditions
- Metabolic Syndrome
- Being tested
- High Protein Diet, Exercise
- Keywords
- epigenetics, obesity, overweight, high protein diet, exercise, post menopausal women
- Medical subject headings
- Metabolic Syndrome, Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein DietBehavioural
All participants will be individually counseled by an RD for ~ 4 sessions (30 to 60 minutes)to meet weight loss goals. During the duration of the study, participants will be required to attend a 30 to 60 minute group educational/motivational meeting weekly (first 1 to 2 months) and then biweekly (for the remainder of the study). Diet recommendations will include high quality proteins with an emphasis on lean meats with protein being targeted for every meal and snack. Regarding beef intake specifically, the prescribed diet will include a minimum of one serving of beef per day, which is approximately 3 to 3.5 ounces or ~100 grams. This amount of lean cooked beef provides an average of ~25-30 grams of protein per day (www.beefnutrition.org/leanbeef.aspx). This combined with reducing energy from carbohydrates and fat from other sources will create an overall energy deficit of 500 kcal/day. This diet will also include 5 servings/day of vegetables and 2-3 servings/day of fruit
ExerciseBehavioural
Participants will be prescribed a supervised exercise program with required attendance of 3 nonconsecutive days per week (75 minutes each session). A program that combines flexibility and balance activities, weight bearing endurance exercise (walking) and resistance training to preserve lean mass will be prescribed. With specific regard to strength training, 50% of the resistance work will involve primary muscle groups of the lower body with the main focus being the gluteal and quadriceps groups (squats, lunges, etc.). The remaining 50% of work will dedicate 25% to the core stabilizers with the final 25% being the upper body. Transitions between segments of training will be used for recovery and social support enhancement. Note that all aspects of the exercise intervention will be progressive in intensity (i.e., starting at lower end of intensity or ~50% of maximal capacity), and duration (i.e., from 15 minutes to 35 minutes of exercise and adding a few minutes each session).
| Study group | Role | What they receive |
|---|---|---|
| High Protien Diet + Exercise | Experimental | All participants will participate in both interventions (High Protein Diet and Exercise). Receives: Behavioral: High Protein Diet; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CD4+T Cells from Baseline to Post-Intervention
The primary aim is to determine if CD4+ T cells will report the differential epigenetic reprogramming of relevant gene expression associated with metabolic indices resulting from EX+CR induced weight loss in older women known to be at risk for MetS.
Measured: Baseline (Week 0), Post-Intervention (Week 24)
Secondary outcomes (2)
Change in Physical Function over 6 Months
A secondary aim is to assess the impact of weight loss on physical function, which will provide pilot data for an additional grant proposal regarding weight management in postmenopausal women.
Measured: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
Change in Psychological Well Being over 6 Months
A battery of psychological assessments will be administered at three time points throughout the study to evaluate possible changes in psychological well being throughout the intervention.
Measured: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Evans, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977885
- Sponsor's protocol ID
- 2013106780
- Acronym
- DIVAS2
- Status last verified
- Sep 2015
- First submitted
- 16 Oct 2013
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-Induced Epigenetic Modifications in Obese Aging Women
- ClinicalTrials.gov ID
- NCT01977885
- Acronym / sponsor ID
- DIVAS2 / 2013106780
- Conditions
- Metabolic Syndrome
- Keywords
- epigenetics, obesity, overweight, high protein diet, exercise, post menopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Nov 2013 (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.
Our greatest public health challenge is obesity and the co-morbidities of metabolic syndrome (MetS). Age is an established risk factor for MetS and specific to women, data indicates that the prevalence of MetS increases substantially with the menopausal transition with postmenopausal women having a 60% increased risk of MetS. Menopause also contributes to reductions in strength, physical function and often psychological well-being (e.g. fatigue). Obese individuals also have: a) impaired immune function and chronic inflammatory responses associated with changes in the white blood cell population in blood and fat tissues; and, b) increased secretion of and signaling by proteins in their fat cells. Weight loss, which requires an energy deficit through increased physical activity and/or caloric restriction (EX+CR), reduces risk for MetS in older sedentary obese women by reducing insulin resistance and chronic systemic inflammation. Science and clinical practice will be advanced by examining the molecular mechanisms by which EX+CR affects risk for MetS in older women. The primary aim is to determine if CD4+ T cells will report the differential epigenetic reprogramming of relevant gene expression associated with metabolic indices resulting from EX+CR induced weight loss in older women known to be at risk for MetS. This pilot data will be used to generate an NIH proposal of the same topic. A secondary aim is to assess the impact of weight loss on physical function and psychological well-being which will provide pilot data for an additional grant proposal regarding weight management in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Protien Diet + Exercise | Experimental | Behavioral: High Protein Diet, Behavioral: ExerciseAll participants will participate in both interventions (High Protein Diet and Exercise). |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Volunteer for the study
- Age between 50 and 64 years
- Self-identified as White or Caucasian
- Postmenopausal
- Sedentary (less than 1 hour each week of planned physical activity and sedentary job)
Key exclusion criteria (13 listed)
- Tobacco use
- Normal weight (BMI < 25 kg/m2)
- Males
- Dietary restrictions that do not allow for the consumption of beef, as required by our dietary protocol
- Weight loss surgery and/or weight loss medications usage
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 |
|---|---|---|
| High Protein DietAll participants will be individually counseled by an RD for ~ 4 sessions (30 to 60 minutes)to meet weight loss goals. During the duration of the study, participants will be required to attend a 30 to 60 minute group educational/motivational meeting weekly (first 1 to 2 months) and then biweekly (for the remainder of the study). Diet recommendations will include high quality proteins with an emphasis on lean meats with protein being targeted for every meal and snack. Regarding beef intake specifically, the prescribed diet will include a minimum of one serving of beef per day, which is approximately 3 to 3.5 ounces or ~100 grams. This amount of lean cooked beef provides an average of ~25-30 grams of protein per day (www.beefnutrition.org/leanbeef.aspx). This combined with reducing energy from carbohydrates and fat from other sources will create an overall energy deficit of 500 kcal/day. This diet will also include 5 servings/day of vegetables and 2-3 servings/day of fruit | Behavioural | High Protien Diet + Exercise |
| ExerciseParticipants will be prescribed a supervised exercise program with required attendance of 3 nonconsecutive days per week (75 minutes each session). A program that combines flexibility and balance activities, weight bearing endurance exercise (walking) and resistance training to preserve lean mass will be prescribed. With specific regard to strength training, 50% of the resistance work will involve primary muscle groups of the lower body with the main focus being the gluteal and quadriceps groups (squats, lunges, etc.). The remaining 50% of work will dedicate 25% to the core stabilizers with the final 25% being the upper body. Transitions between segments of training will be used for recovery and social support enhancement. Note that all aspects of the exercise intervention will be progressive in intensity (i.e., starting at lower end of intensity or ~50% of maximal capacity), and duration (i.e., from 15 minutes to 35 minutes of exercise and adding a few minutes each session). | Behavioural | High Protien Diet + Exercise |
Primary outcome
Change in CD4+T Cells from Baseline to Post-Intervention
Time frame: Baseline (Week 0), Post-Intervention (Week 24)
The primary aim is to determine if CD4+ T cells will report the differential epigenetic reprogramming of relevant gene expression associated with metabolic indices resulting from EX+CR induced weight loss in older women known to be at risk for MetS.
2 secondary outcomes
Change in Physical Function over 6 Months
Time frame: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
Change in Psychological Well Being over 6 Months
Time frame: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
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 25 Sep 2015.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein Diet and Exercise in people with Metabolic Syndrome, run by University of Georgia 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 12 inclusion and 13 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 25 Sep 2015. 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?
Change in CD4+T Cells from Baseline to Post-Intervention (time frame: Baseline (Week 0), Post-Intervention (Week 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2015.