Body Composition, Energy Balance, Physical Function
Conditions
Keywords
Fat mass, muscle mass, physical function, energy deficit
Brief 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. 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.
Interventions
BEHAVIORALStructured nutrition plan
Participants will receive a structured nutrition plan.
BEHAVIORALTypical or usual diet
Participants will receive a diet representing the usual diet in this population.
BEHAVIORALSupervised Exercise
Participants will complete aerobic and resistance training under supervision three times per week.
Sponsors
Pennington Biomedical Research Center
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 50 years. 2. Body mass index (BMI) ≥ 30 kg/m2. 3. Homeostatic model assessment of insulin resistance ≥ 3. 4. Mini-Mental State Examination (MMSE) \> 25. 5. Geriatric Depression Scale-15 (GDS-15) \< 9. 6. Sedentary (less than 90 minutes/week of moderate to vigorous activity). 7. Ability to provide written informed consent.
Exclusion criteria
1. 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. 2. Clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, celiac disease, or clinically significant abnormal laboratory markers. 3. Fluctuation in body weight \> 3 kg in the preceding two months 4. Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat mass | Change from baseline to 12 weeks | Fat mass measured by dual X-ray absorptiometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal muscle mass | Change in from baseline to 12 weeks | Skeletal muscle mass will be measured by the creatine methyl D-3 dilution method |
| Short physical performance battery | Change from baseline to 12 weeks | A test of physical function |
| Hand-grip strength | Change from baseline to 12 weeks | Hand grip strength will be measured using a hand dynamometer |
| Knee strength | Change from baseline to12 weeks | Knee strength will be measured quantified using Biodex dynamometry |
| Energy stores | 12 weeks | Change in energy stores/day (kcal) determined from measures of body composition using the energy balance method |
| Hormonal regulation of energy balance | Change from baseline to 12 weeks | Blood concentrations of glucagon-like peptide 1 |
| Cardiorespiratory fitness | Change in VO2max from baseline to 12 weeks | VO2max |
Countries
United States
Contacts
CONTACTCandida J Rebello, PhD, RD
CONTACTReilly Roberts A Project Manager, MS
PRINCIPAL_INVESTIGATORCandida J Rebello, PhD, RD
Pennington Biomedical Research Center
Outcome results
None listed