ObesityPhase 4NCT00315146
Optimizing Body Composition for Function in Older Adults
A Phase 4 study testing Pioglitazone, Resistance exercise training to maximize muscle power and Hypocaloric diet in people with Obesity and Overweight With Indications for Weight Loss, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this pilot study is to compare two strategies intended to improve the health of overweight older adults by improving body composition. One strategy, resistance training, is designed to preserve skeletal muscle mass. Read more about this study
- Who is it for?
- Ages 65 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight With Indications for Weight Loss
- What is being tested?
- Pioglitazone, Resistance exercise training to maximize muscle power and Hypocaloric diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Apr 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 79 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Weight Stable, Indication for weight loss per NIH guidelines, Performance on the short physical performance battery score 3-10
Who cannot join
- Diabetes, weight > 136 kg, Medical condition that limits exercise participation, Congestive heart failure, abnormal kidney function, higher ALT than normal, currently involved in a weight loss or exercise program, current smoking, alcohol or drug abuse, taking anti-inflammatory steroids, taking protein supplements, taking PPAR-gamma agonist, edema, anemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Sticht Center on Aging, Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Optimizing Body Composition for Function in Older Adults (OPTIMA) - A Pepper Pilot Study
The purpose of this pilot study is to compare two strategies intended to improve the health of overweight older adults by improving body composition. One strategy, resistance training, is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ agonist, is designed to enhance the loss of fat from visceral and skeletal depots. These strategies will be used in conjunction with a hypocaloric diet and will be compared to a hypocaloric diet alone to determine if either of these strategies are superior in reducing visceral fat and preserving muscle mass.
Read the detailed description
In this pilot we propose to recruit 88 older (65 - 79 yrs) men (n=48) and women (n=40) at risk for disability and with indications for weight loss according to NIH guidelines. All will be enrolled in a dietary intervention designed to generate a caloric deficit of 500 kcal/day for a 4 month period. All will receive supplemental vitamin D and calcium. These participants will be randomized into one of 4 groups:
Group 1 - Hypocaloric diet (and placebo) Group 2 - Hypocaloric diet and resistance training designed to maximize muscular power (and placebo) Group 3 - Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™) Group 4 - Hypocaloric diet and resistance training and pioglitazone/Actos™
The specific aims of the pilot are:
- In both men and women, to determine whether randomization to resistance exercise is associated with an increased retention of appendicular non-bone lean mass compared to those not undergoing power training.
- In both men and women, to determine whether randomization to the pioglitazone group is associated with an increased loss of visceral adiposity relative to randomization to the non-pioglitazone group.
- Assess the feasibility of the recruitment, assessment and intervention strategies
- To estimate adherence to the weight loss, exercise training, and drug interventions;
- In this population, to determine measurement characteristics of the functional outcomes that will be considered as primary end-points of the larger study.
- To obtain pilot data on a subset of participants to determine the feasibility, acceptability and measurement characteristics of muscle samples (biopsies) to quantify intramyocellular lipid in this study population.
- Being tested
- Pioglitazone, Resistance exercise training to maximize muscle power, Hypocaloric diet, Placebo
- Keywords
- Body Composition, Sarcopenia, Weight loss trials, Intervention studies, Elderly
- Medical subject headings
- Obesity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Resistance exercise training to maximize muscle powerBehavioural
Hypocaloric dietBehavioural
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Hypocaloric diet (and placebo) | Placebo comparator | Not described Receives: Behavioral: Hypocaloric diet; Drug: Placebo |
| Hypocaloric diet, resist. training to maximize power, placebo | Active comparator | Not described Receives: Behavioral: Resistance exercise training to maximize muscle power; Behavioral: Hypocaloric diet; Drug: Placebo |
| Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™) | Active comparator | Not described Receives: Drug: Pioglitazone; Behavioral: Hypocaloric diet |
| Hypocaloric diet,resistance training, pioglitazone/Actos™ | Active comparator | Not described Receives: Drug: Pioglitazone; Behavioral: Resistance exercise training to maximize muscle power; Behavioral: Hypocaloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular Non-bone Lean Mass
Change in Appendicular Non-bone Lean Mass
Measured: Baseline visit (pre intervention) and 4month follow up (post intervention)
Secondary outcomes (1)
Lean Body Mass
Measured: Baseline visit (pre intervention) and 4month follow up (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc., National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Stephen B Kritchevsky, PhD, Principal investigator, Sticht Center on Aging, Wake Forest University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315146
- Sponsor's protocol ID
- BG06-051
- Other IDs
- P30AG021332
- Status last verified
- Jul 2018
- First submitted
- 13 Apr 2006
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Body Composition for Function in Older Adults (OPTIMA) - A Pepper Pilot Study
- ClinicalTrials.gov ID
- NCT00315146
- Acronym / sponsor ID
- BG06-051
- Keywords
- Body Composition, Sarcopenia, Weight loss trials, Intervention studies, Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc., National Institute on Aging (NIA)
- Study start
- Apr 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 17 Apr 2006 (estimated)
- Results
- Posted 19 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to compare two strategies intended to improve the health of overweight older adults by improving body composition. One strategy, resistance training, is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ agonist, is designed to enhance the loss of fat from visceral and skeletal depots. These strategies will be used in conjunction with a hypocaloric diet and will be compared to a hypocaloric diet alone to determine if either of these strategies are superior in reducing visceral fat and preserving muscle mass.
Detailed description
In this pilot we propose to recruit 88 older (65 - 79 yrs) men (n=48) and women (n=40) at risk for disability and with indications for weight loss according to NIH guidelines. All will be enrolled in a dietary intervention designed to generate a caloric deficit of 500 kcal/day for a 4 month period. All will receive supplemental vitamin D and calcium. These participants will be randomized into one of 4 groups:
Group 1 - Hypocaloric diet (and placebo) Group 2 - Hypocaloric diet and resistance training designed to maximize muscular power (and placebo) Group 3 - Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™) Group 4 - Hypocaloric diet and resistance training and pioglitazone/Actos™
The specific aims of the pilot are:
- In both men and women, to determine whether randomization to resistance exercise is associated with an increased retention of appendicular non-bone lean mass compared to those not undergoing power training.
- In both men and women, to determine whether randomization to the pioglitazone group is associated with an increased loss of visceral adiposity relative to randomization to the non-pioglitazone group.
- Assess the feasibility of the recruitment, assessment and intervention strategies
- To estimate adherence to the weight loss, exercise training, and drug interventions;
- In this population, to determine measurement characteristics of the functional outcomes that will be considered as primary end-points of the larger study.
- To obtain pilot data on a subset of participants to determine the feasibility, acceptability and measurement characteristics of muscle samples (biopsies) to quantify intramyocellular lipid in this study population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypocaloric diet (and placebo) | Placebo comparator | Behavioral: Hypocaloric diet, Drug: Placebo |
| Hypocaloric diet, resist. training to maximize power, placebo | Active comparator | Behavioral: Resistance exercise training to maximize muscle power, Behavioral: Hypocaloric diet, Drug: Placebo |
| Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™) | Active comparator | Drug: Pioglitazone, Behavioral: Hypocaloric diet |
| Hypocaloric diet,resistance training, pioglitazone/Actos™ | Active comparator | Drug: Pioglitazone, Behavioral: Resistance exercise training to maximize muscle power, Behavioral: Hypocaloric diet |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Weight Stable, Indication for weight loss per NIH guidelines, Performance on the short physical performance battery score 3-10
Key exclusion criteria (1 listed)
- Diabetes, weight > 136 kg, Medical condition that limits exercise participation, Congestive heart failure, abnormal kidney function, higher ALT than normal, currently involved in a weight loss or exercise program, current smoking, alcohol or drug abuse, taking anti-inflammatory steroids, taking protein supplements, taking PPAR-gamma agonist, edema, anemia
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 |
|---|---|---|
| Pioglitazone | Drug | Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™), Hypocaloric diet,resistance training, pioglitazone/Actos™ |
| Resistance exercise training to maximize muscle power | Behavioural | Hypocaloric diet, resist. training to maximize power, placebo, Hypocaloric diet,resistance training, pioglitazone/Actos™ |
| Hypocaloric diet | Behavioural | Hypocaloric diet (and placebo), Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™), Hypocaloric diet, resist. training to maximize power, placebo, Hypocaloric diet,resistance training, pioglitazone/Actos™ |
| Placebo | Drug | Hypocaloric diet (and placebo), Hypocaloric diet, resist. training to maximize power, placebo |
Primary outcome
Appendicular Non-bone Lean Mass
Time frame: Baseline visit (pre intervention) and 4month follow up (post intervention)
Change in Appendicular Non-bone Lean Mass
1 secondary outcome
Lean Body Mass
Time frame: Baseline visit (pre intervention) and 4month follow up (post intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Not yet recruitingPhase 3
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1/2
Investigating the Effects of 24 Hour LEAP2 Infusion in Individuals With Overweight and Obesity
Obesity & Overweight
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.
Stephen B Kritchevsky, PhD principal investigator
Sticht Center on Aging, Wake Forest University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pioglitazone, Resistance exercise training to maximize muscle power and Hypocaloric diet in people with Obesity and Overweight With Indications for Weight Loss, run by Wake Forest University Health Sciences 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 1 inclusion and 1 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 28 Aug 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Appendicular Non-bone Lean Mass (time frame: Baseline visit (pre intervention) and 4month follow up (post intervention)). 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 28 Aug 2018.