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| Name | Class |
|---|---|
| National Pork Board | OTHER |
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The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from lean pork and other animal source proteins) with calorie restriction on functional status and lean muscle mass in frail, obese, women who participate in a 6 month intervention and 9 month intervention.
Assess the effects of combining regular, generous intakes of high quality protein (primarily from lean pork and other animal source proteins) with calorie restriction on functional status and lean muscle mass in frail, obese, women who participate in a 6 month intervention and 9 month intervention.
For 6 month intervention: Participants will be randomized into one of two study arms: Weight Loss Control (n = 20) subjects follow a calorie-reduced diet for a weight loss or ≥10%; or Weight Loss-High Protein: (n = 40) 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 pork. Subject criteria will include obese (>30 kg/m2) women (≥ 45 yrs.) with mild to moderate functional impairment (by 6 minute walk).
For 9 month intervention: Participants will be randomized into one of two study arms: Weight Loss Control (n = 10) subjects follow a calorie-reduced diet for a weight loss or ≥10%; or Weight Loss-High Protein: (n = 10) 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 pork. Subject criteria will include obese (≥ 30 kg/m2) women (≥ 60 yrs.) with mild to moderate functional impairment (by 6 minute walk).
This is a randomized clinical trial with repeated measurements, with the purpose of assessing change over time for the overall sample and the difference in the High Protein group relative to the Control group with regards to primary outcomes (function and lean body mass). The statistical analyses will proceed chronologically in 3 phases: 1) descriptive analyses that will summarize the distribution of the covariates and dependent variables, 2) bivariate analyses of the association between group membership and the outcome measures, and 3) controlled multivariable analyses, which assess the association between experimental group and the outcomes, controlling for the important covariates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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% of animal protein from pork. |
|
| Weight loss control | Active Comparator | Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%. |
|
| 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 lean pork. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical function | Assess the change in 6 minute walk scores at 4, 6, and 9 months | Baseline, 4, 6, and 9 months |
| Lean Mass | To assess the change in lean mass at 3 or 4 time points. | Baseline, 4, 6, and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function | To assess the change in SPPB at 4, 6, and 9 months | Baseline, 4, 6, and 9 months |
| Weight Loss | To assess the change in body weight at 4, 6, and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline lipid classes at 6 months | Concentrations for lipoprotein classes (VLDL, LDL and HDL particle numbers) were calculated using the LP3 deconvolution algorithm. | Baseline to 6 months |
| Change in baseline lipid subclasses at 6 months |
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 Universtiy Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29517074 | Derived | Bales CW, Porter Starr KN, Orenduff MC, McDonald SR, Molnar K, Jarman AK, Onyenwoke A, Mulder H, Payne ME, Pieper CF. Influence of Protein Intake, Race, and Age on Responses to a Weight-Reduction Intervention in Obese Women. Curr Dev Nutr. 2017 May 1;1(5):e000703. doi: 10.3945/cdn.117.000703. Epub 2017 Apr 11. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| 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 | Participants meet once a week for 6 months to participate in group lessons and counseling. |
|
| Baseline, 4, 6, and 9 months |
| Fat Mass | To assess the change in fat mass at 4, 6, and 9 months | Baseline, 4, 6, and 9 months |
Concentrations for lipoprotein (VLDL, LDL, and HDL) subclasses (small, medium and large) were calculated using the LP3 deconvolution algorithm.
| Baseline to 6 months |
| Change in baseline lipid participle sizes at 6 months | 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. | 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 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 Estimated 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 |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |