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| ID | Type | Description | Link |
|---|---|---|---|
| 3834193 | Other Grant/Funding Number | National Cattlemen's Beef Association |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Loss Control | Active Comparator | Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%. |
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| Weight Loss-High Protein | Experimental | Protein supplementation. Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of protein, including substantial amounts of supplemental protein provided as lean beef. Intakes of > 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein supplementation | Dietary Supplement | > 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB) | short physical performance battery | Baseline to 3 to 6 months |
| Change in lean body mass | Bodpod | Baseline to 3 and 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline lipids (classes, subclasses, participle size and number) at 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Connie W Bales, PhD, RD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30810500 | Derived | Porter Starr KN, Orenduff M, McDonald SR, Mulder H, Sloane R, Pieper CF, Bales CW. Influence of Weight Reduction and Enhanced Protein Intake on Biomarkers of Inflammation in Older Adults with Obesity. J Nutr Gerontol Geriatr. 2019 Jan-Mar;38(1):33-49. doi: 10.1080/21551197.2018.1564200. Epub 2019 Feb 27. | |
| 30498835 | Derived |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Diet counseling and group education lessons | Behavioral | Individual and group diet counseling to achieve a >10% weight loss |
|
| Baseline to 6 months |
| Changes in baseline GlycA at 6 months | NMR-measured systemic inflammatory factor and a biomarker of CVD risk | Baseline to 6 months |
| Change in baseline trimethylamine-N-oxide (TMAO) at 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. | Baseline to 6 months |
| Change in baseline betaine at 6 months | Betaine was measured by 1H-nuclear magnetic resonance (NMR) spectroscopy using a Vantera® NMR Clinical Analyzer (LabCorp, Raleigh, NC). | Baseline to 6 months |
| Change in baseline branched chain amino acids (BCAA) at 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. | Baseline to 6 months |
| Change in baseline Lipoprotein Insulin Resistance Index (LP-IR) scores at 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. | Baseline to 6 months |
| Change in baseline GFR at 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. | Baseline to 6 months |
| Change in baseline fasting glucose at 6 months | Level of glucose in the blood after fasting for at least 8 hours | Baseline to 6 months |
| Payne ME, Porter Starr KN, Orenduff M, Mulder HS, McDonald SR, Spira AP, Pieper CF, Bales CW. Quality of Life and Mental Health in Older Adults with Obesity and Frailty: Associations with a Weight Loss Intervention. J Nutr Health Aging. 2018;22(10):1259-1265. doi: 10.1007/s12603-018-1127-0. |
| 26786203 | Derived | Porter Starr KN, Pieper CF, Orenduff MC, McDonald SR, McClure LB, Zhou R, Payne ME, Bales CW. Improved Function With Enhanced Protein Intake per Meal: A Pilot Study of Weight Reduction in Frail, Obese Older Adults. J Gerontol A Biol Sci Med Sci. 2016 Oct;71(10):1369-75. doi: 10.1093/gerona/glv210. Epub 2016 Jan 18. |
| 25461495 | Derived | McDonald SR, Porter Starr KN, Mauceri L, Orenduff M, Granville E, Ocampo C, Payne ME, Pieper CF, Bales CW. Meal-based enhancement of protein quality and quantity during weight loss in obese older adults with mobility limitations: rationale and design for the MEASUR-UP trial. Contemp Clin Trials. 2015 Jan;40:112-23. doi: 10.1016/j.cct.2014.11.010. Epub 2014 Nov 20. |