Weight Loss
Conditions
Keywords
Function, Muscle mass
Brief summary
The purpose of the trial is to assess the effects of weight loss on functional status and lean muscle mass in frail, obese older adults (\>/= 60) who participate in a 6 month weight reduction intervention. Participants will be randomized into one of two study arms: Weight Loss Control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%; or Weight Loss-High Protein: (n = 50) subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of \> 30g of high quality protein will be achieved three times a day by subjects in this group, predominantly all from animal sources and 60-70% of animal protein from beef. Subject criteria will include obese (\>30 kg/m2) older adults (\>60 yrs.) with mild to moderate functional impairment (by Short Physical Performance Battery; SPPB score \>/= 4)
Interventions
DIETARY_SUPPLEMENTProtein supplementation
\> 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from beef.
Individual and group diet counseling to achieve a \>10% weight loss
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 60+ yrs. * BMI of \>30 kg/m2 * Body weight \<495 lbs. * Normal blood chemistries * Normal renal function * Primary care physician acknowledgement * Non-Vegetarian * Mild to moderate movement impairment
Exclusion criteria
* Body weight \>495 pounds. * Current smoker. * Presence of unstable, acutely symptomatic, or life-limiting illness. * Positive screen for dementia using Mini-Cog evaluation tool. * Neurological conditions causing functional or cognitive impairments. * History of significant weight instability (defined as \> 10 pounds weight gain or loss over 6 months prior to study participation). * Unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing or continuously participate in a randomly assigned lifestyle intervention program for six months. * Inability to walk independently. * Bilateral hip replacements. * Unable to give consent. * Unable to complete written recording forms including journals of eating and exercise behaviors. * Current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications. * Primary Care Physician advises against participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB) | Baseline to 3 to 6 months | short physical performance battery |
| Change in lean body mass | Baseline to 3 and 6 months | Bodpod |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline trimethylamine-N-oxide (TMAO) at 6 months | Baseline to 6 months | TMAO is a metabolite produced from trimethylamine (TMA) containing nutrients. Nuclear magnetic resonance (NMR) spectroscopy assay was used for quantification of TMAO concentrations. |
| Change in baseline betaine at 6 months | Baseline to 6 months | Betaine was measured by 1H-nuclear magnetic resonance (NMR) spectroscopy using a Vantera® NMR Clinical Analyzer (LabCorp, Raleigh, NC). |
| Change in baseline branched chain amino acids (BCAA) at 6 months | Baseline to 6 months | NMR MetaboProfile analysis, which reports concentrations of several metabolites \[ the branched chain amino acids (BCAA) valine, leucine, and isoleucine\] was performed using the recently developed LP3 deconvolution algorithm. |
| Change in baseline lipids (classes, subclasses, participle size and number) at 6 months | Baseline to 6 months | Concentrations for lipoprotein classes (VLDL, LDL and HDL particle numbers) and subclasses (small, medium and large) were calculated using the LP3 deconvolution algorithm. Mean VLDL, LDL and HDL particle sizes were weighted averages derived from the sum of the diameter of each subclass multiplied by its relative mass percentage. |
| Change in baseline GFR at 6 months | Baseline to 6 months | Estimated GFR, which measures renal filtering capacity, is a calculated value based on age, sex, race, and serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. |
| Change in baseline fasting glucose at 6 months | Baseline to 6 months | Level of glucose in the blood after fasting for at least 8 hours |
| Change in baseline Lipoprotein Insulin Resistance Index (LP-IR) scores at 6 months | Baseline to 6 months | LP-IR is a composite metabolomic biomarker that captures the multidimensional effects of insulin resistance on the lipoprotein metabolic chain. It is measured by nuclear magnetic resonance spectroscopy as a weighted score of VLDL, LDL and HDL particle sizes, and their subsets concentrations. |
| Changes in baseline GlycA at 6 months | Baseline to 6 months | NMR-measured systemic inflammatory factor and a biomarker of CVD risk |
Countries
United States
Outcome results
None listed