A High Protein Weight Loss Intervention for Sarcopenic Obesity in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Physical function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 45+ 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
排除标准
- •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.
研究组 & 干预措施
Weight loss high protein
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.
干预措施: Protein supplementation (Dietary Supplement)
Weight loss high protein
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.
干预措施: Diet counseling and group education lessons (Behavioral)
Weight loss control
Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%.
干预措施: Diet counseling and group education lessons (Behavioral)
结局指标
主要结局
Physical function
时间窗: Baseline, 4, 6, and 9 months
Assess the change in 6 minute walk scores at 4, 6, and 9 months
Lean Mass
时间窗: Baseline, 4, 6, and 9 months
To assess the change in lean mass at 3 or 4 time points.
次要结局
- Weight Loss(Baseline, 4, 6, and 9 months)
- Physical Function(Baseline, 4, 6, and 9 months)
- Fat Mass(Baseline, 4, 6, and 9 months)