Body CompositionNCT07597980
Lifestyle Intervention to Improve Muscle Function in Older Adults
A study testing Structured nutrition plan, Typical or usual diet and Supervised Exercise in people with Body Composition and Physical Function, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The goal of this randomized controlled two-arm trial is to determine the effect of a diet and exercise intervention for 12 weeks on body composition, muscle function, and energy balance in 80 adults aged 50 years and over with obesity and insulin resistance. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Body Composition, Physical Function, Energy Balance
- What is being tested?
- Structured nutrition plan, Typical or usual diet and Supervised Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 50 years.
- Body mass index (BMI) ≥ 30 kg/m2.
- Homeostatic model assessment of insulin resistance ≥ 3.
- Mini-Mental State Examination (MMSE) > 25.
- Geriatric Depression Scale-15 (GDS-15) < 9.
- Sedentary (less than 90 minutes/week of moderate to vigorous activity).
- Ability to provide written informed consent.
Who cannot join
- Diagnosis of cancer (received within five years) or diabetes (type 1 and 2), or significant musculoskeletal, or cardiovascular, or hepatic, or renal, disease or dysfunction.
- Clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, celiac disease, or clinically significant abnormal laboratory markers.
- Fluctuation in body weight > 3 kg in the preceding two months
- Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Candida J Rebello, PhD, RD, 225-763-3159, Candida.Rebello@pbrc.edu
Reilly Roberts A Project Manager, MS, 225-763-2854, Reilly.Roberts@pbrc.edu
About this study
The goal of this randomized controlled two-arm trial is to determine the effect of a diet and exercise intervention for 12 weeks on body composition, muscle function, and energy balance in 80 adults aged 50 years and over with obesity and insulin resistance. The main questions the trial aims to answer are: Will 12 weeks of a structured nutrition plan + exercise reduce fat mass, improve muscle function, and increase energy deficit compared to the usual diet + exercise. The hypothesis is that 12 weeks of a structured nutrition plan + exercise will reduce fat mass, improve muscle function, and produce greater energy deficit than the usual diet + exercise. Participants will be provided with all meals for 12 weeks and will exercise at the Center under supervision three times each week. Pre and post-intervention, body composition, physical function, and energy deficit will be measured.
Read the detailed description
In the United States nearly one third of adults over 60 years of age have sarcopenic obesity which encompasses the combined effect of muscle impairment and obesity. A strategy that addresses the combined effect of muscle impairment and obesity while modulating muscle mass and composition is an unanswered challenge. This 12-week study will evaluate the effects of a structured nutrition plan combined with an exercise program on body fat and muscle mass, lower-extremity function (Short Physical Performance Battery), muscle strength (handgrip and knee strength), and daily caloric intake. The study will enroll adults aged 50 years and older with obesity (body mass index ≥ 30 kg/m²) and insulin resistance as indicated by a homeostasis model assessment of insulin resistance (HOMA-IR) score ≥ 3. Subjects will be randomly allocated to receive the structured nutrition plan and exercise intervention or to their usual diet and exercise in equal numbers (40 per group). The study will enrich our understanding of the physiological adaptations necessary for effective lifestyle interventions to improve muscle function.
- Conditions
- Body Composition, Physical Function, Energy Balance
- Being tested
- Structured nutrition plan, Typical or usual diet, Supervised Exercise
- Keywords
- Fat mass, muscle mass, physical function, energy deficit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured nutrition planBehavioural
Participants will receive a structured nutrition plan.
Typical or usual dietBehavioural
Participants will receive a diet representing the usual diet in this population.
Supervised ExerciseBehavioural
Participants will complete aerobic and resistance training under supervision three times per week.
| Study group | Role | What they receive |
|---|---|---|
| Structured nutrition plan + exercise | Experimental | Intervention: Participants receive a structured nutrition plan, and exercise under supervision. Receives: Behavioral: Structured nutrition plan; Behavioral: Supervised Exercise |
| Typical or usual diet + exercise | Active comparator | Participants receive a typical or usual diet, and exercise under supervision Receives: Behavioral: Typical or usual diet; Behavioral: Supervised Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass
Fat mass measured by dual X-ray absorptiometry
Measured: Change from baseline to 12 weeks
Secondary outcomes (10)
Skeletal muscle mass
Skeletal muscle mass will be measured by the creatine methyl D-3 dilution method
Measured: Change in from baseline to 12 weeks
Short physical performance battery
A test of physical function
Measured: Change from baseline to 12 weeks
Hand-grip strength
Hand grip strength will be measured using a hand dynamometer
Measured: Change from baseline to 12 weeks
Knee strength
Knee strength will be measured quantified using Biodex dynamometry
Measured: Change from baseline to12 weeks
Energy stores
Change in energy stores/day (kcal) determined from measures of body composition using the energy balance method
Measured: 12 weeks
Hormonal regulation of energy balance
Blood concentrations of glucagon-like peptide 1
Measured: Change from baseline to 12 weeks
Hormonal regulation of energy balance
Blood concentrations of gastric inhibitory peptide
Measured: Change from baseline to 12 weeks
Hormonal regulation of energy balance
Blood concentrations of cortisol
Measured: Change from baseline to 12 weeks
Hormonal regulation of energy balance
Blood concentrations of leptin
Measured: Change from baseline to 12 weeks
Cardiorespiratory fitness
VO2max
Measured: Change in VO2max from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start20 Jul 2026
- Primary completionJun 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Candida Rebello, Pennington Biomedical Research Center
- Investigators
- Candida J Rebello, PhD, RD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597980
- Sponsor's protocol ID
- PBRC-2025-060
- Other IDs
- 1R01AG092725-01A1
- Status last verified
- Jul 2026
- First submitted
- 8 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, we do not have plans to share IPD. We may consider it after the study results have been publicly disseminated
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention to Improve Muscle Function in Older Adults
- ClinicalTrials.gov ID
- NCT07597980
- Acronym / sponsor ID
- PBRC-2025-060
- Conditions
- Body Composition, Physical Function, Energy Balance
- Keywords
- Fat mass, muscle mass, physical function, energy deficit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 20 May 2026 (actual)
- 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.
The goal of this randomized controlled two-arm trial is to determine the effect of a diet and exercise intervention for 12 weeks on body composition, muscle function, and energy balance in 80 adults aged 50 years and over with obesity and insulin resistance. The main questions the trial aims to answer are: Will 12 weeks of a structured nutrition plan + exercise reduce fat mass, improve muscle function, and increase energy deficit compared to the usual diet + exercise. The hypothesis is that 12 weeks of a structured nutrition plan + exercise will reduce fat mass, improve muscle function, and produce greater energy deficit than the usual diet + exercise. Participants will be provided with all meals for 12 weeks and will exercise at the Center under supervision three times each week. Pre and post-intervention, body composition, physical function, and energy deficit will be measured.
Detailed description
In the United States nearly one third of adults over 60 years of age have sarcopenic obesity which encompasses the combined effect of muscle impairment and obesity. A strategy that addresses the combined effect of muscle impairment and obesity while modulating muscle mass and composition is an unanswered challenge. This 12-week study will evaluate the effects of a structured nutrition plan combined with an exercise program on body fat and muscle mass, lower-extremity function (Short Physical Performance Battery), muscle strength (handgrip and knee strength), and daily caloric intake. The study will enroll adults aged 50 years and older with obesity (body mass index ≥ 30 kg/m²) and insulin resistance as indicated by a homeostasis model assessment of insulin resistance (HOMA-IR) score ≥ 3. Subjects will be randomly allocated to receive the structured nutrition plan and exercise intervention or to their usual diet and exercise in equal numbers (40 per group). The study will enrich our understanding of the physiological adaptations necessary for effective lifestyle interventions to improve muscle function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured nutrition plan + exercise | Experimental | Behavioral: Structured nutrition plan, Behavioral: Supervised ExerciseIntervention: Participants receive a structured nutrition plan, and exercise under supervision. |
| Typical or usual diet + exercise | Active comparator | Behavioral: Typical or usual diet, Behavioral: Supervised ExerciseParticipants receive a typical or usual diet, and exercise under supervision |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 50 years.
- Body mass index (BMI) ≥ 30 kg/m2.
- Homeostatic model assessment of insulin resistance ≥ 3.
- Mini-Mental State Examination (MMSE) > 25.
- Geriatric Depression Scale-15 (GDS-15) < 9.
Key exclusion criteria (4 listed)
- Diagnosis of cancer (received within five years) or diabetes (type 1 and 2), or significant musculoskeletal, or cardiovascular, or hepatic, or renal, disease or dysfunction.
- Clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, celiac disease, or clinically significant abnormal laboratory markers.
- Fluctuation in body weight > 3 kg in the preceding two months
- Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods.
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 |
|---|---|---|
| Structured nutrition planParticipants will receive a structured nutrition plan. | Behavioural | Structured nutrition plan + exercise |
| Typical or usual dietParticipants will receive a diet representing the usual diet in this population. | Behavioural | Typical or usual diet + exercise |
| Supervised ExerciseParticipants will complete aerobic and resistance training under supervision three times per week. | Behavioural | Structured nutrition plan + exercise, Typical or usual diet + exercise |
Primary outcome
Fat mass
Time frame: Change from baseline to 12 weeks
Fat mass measured by dual X-ray absorptiometry
10 secondary outcomes
Skeletal muscle mass
Time frame: Change in from baseline to 12 weeks
Short physical performance battery
Time frame: Change from baseline to 12 weeks
Hand-grip strength
Time frame: Change from baseline to 12 weeks
Knee strength
Time frame: Change from baseline to12 weeks
Energy stores
Time frame: 12 weeks
Hormonal regulation of energy balance
Time frame: Change from baseline to 12 weeks
Hormonal regulation of energy balance
Time frame: Change from baseline to 12 weeks
Hormonal regulation of energy balance
Time frame: Change from baseline to 12 weeks
Hormonal regulation of energy balance
Time frame: Change from baseline to 12 weeks
Cardiorespiratory fitness
Time frame: Change in VO2max from baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. At this time, we do not have plans to share IPD. We may consider it after the study results have been publicly disseminated
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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.
Candida J Rebello, PhD, RD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured nutrition plan, Typical or usual diet and Supervised Exercise in people with Body Composition and Physical Function, run by Pennington Biomedical Research Center 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Candida J Rebello, PhD, RD (12257633159, Candida.Rebello@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat mass (time frame: Change from baseline to 12 weeks). 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 15 Oct 2026.