An interventional study of Structured nutrition plan and Typical or usual diet in Body Composition, Physical Function and Energy Balance, sponsored by Pennington Biomedical Research Center. Recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Treatment
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.
Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention: Participants receive a structured nutrition plan, and exercise under supervision.
Behavioral: Structured nutrition plan · Behavioral: Supervised Exercise
Participants receive a typical or usual diet, and exercise under supervision
Behavioral: Typical or usual diet · Behavioral: Supervised Exercise
Participants will receive a structured nutrition plan.
Participants will receive a diet representing the usual diet in this population.
Participants will complete aerobic and resistance training under supervision three times per week.
Fat mass
Fat mass measured by dual X-ray absorptiometry
Time frame: Change from baseline to 12 weeks
Skeletal muscle mass
Skeletal muscle mass will be measured by the creatine methyl D-3 dilution method
Time frame: Change in from baseline to 12 weeks
Short physical performance battery
A test of physical function
Time frame: Change from baseline to 12 weeks
Hand-grip strength
Hand grip strength will be measured using a hand dynamometer
Time frame: Change from baseline to 12 weeks
Knee strength
Knee strength will be measured quantified using Biodex dynamometry
Time frame: Change from baseline to12 weeks
Energy stores
Change in energy stores/day (kcal) determined from measures of body composition using the energy balance method
Time frame: 12 weeks
Hormonal regulation of energy balance
Blood concentrations of glucagon-like peptide 1
Time frame: Change from baseline to 12 weeks
Hormonal regulation of energy balance
Blood concentrations of gastric inhibitory peptide
Time frame: Change from baseline to 12 weeks
Hormonal regulation of energy balance
Blood concentrations of cortisol
Time frame: Change from baseline to 12 weeks
Hormonal regulation of energy balance
Blood concentrations of leptin
Time frame: Change from baseline to 12 weeks
Cardiorespiratory fitness
VO2max
Time frame: Change in VO2max from baseline to 12 weeks
Plan to share: No — At this time, we do not have plans to share IPD. We may consider it after the study results have been publicly disseminated
No publications or documents are linked to this record.
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Pennington Biomedical Research Center