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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG092725-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured nutrition plan + exercise | Experimental | Intervention: Participants receive a structured nutrition plan, and exercise under supervision. |
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| Typical or usual diet + exercise | Active Comparator | Participants receive a typical or usual diet, and exercise under supervision |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured nutrition plan | Behavioral | Participants will receive a structured nutrition plan. |
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| Measure | Description | Time Frame |
|---|---|---|
| Fat mass | Fat mass measured by dual X-ray absorptiometry | Change from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal muscle mass | Skeletal muscle mass will be measured by the creatine methyl D-3 dilution method | Change in from baseline to 12 weeks |
| Short physical performance battery | A test of physical function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Candida J Rebello, PhD, RD | Contact | 12257633159 | Candida.Rebello@pbrc.edu | |
| Reilly Roberts A Project Manager, MS | Contact | 225-763-2854 | candidajoan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Candida J Rebello, PhD, RD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Recruiting | Baton Rouge | Louisiana | 70808 | United States |
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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| Typical or usual diet | Behavioral | Participants will receive a diet representing the usual diet in this population. |
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| Supervised Exercise | Behavioral | Participants will complete aerobic and resistance training under supervision three times per week. |
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| Change from baseline to 12 weeks |
| Hand-grip strength | Hand grip strength will be measured using a hand dynamometer | Change from baseline to 12 weeks |
| Knee strength | Knee strength will be measured quantified using Biodex dynamometry | Change from baseline to12 weeks |
| Energy stores | Change in energy stores/day (kcal) determined from measures of body composition using the energy balance method | 12 weeks |
| Hormonal regulation of energy balance | Blood concentrations of glucagon-like peptide 1 | Change from baseline to 12 weeks |
| Hormonal regulation of energy balance | Blood concentrations of gastric inhibitory peptide | Change from baseline to 12 weeks |
| Hormonal regulation of energy balance | Blood concentrations of cortisol | Change from baseline to 12 weeks |
| Hormonal regulation of energy balance | Blood concentrations of leptin | Change from baseline to 12 weeks |
| Cardiorespiratory fitness | VO2max | Change in VO2max from baseline to 12 weeks |