EXERT-BC Protein: Randomized Study of Protein Supplementation to Improve Body Composition Improvement During Hypertrophy Exercise After Treatment for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Determine changes in pounds of muscle and fat mass after each exercise regimen
研究概览
简要总结
In this study, the investigators hypothesize that a high dose of post-workout protein after each exercise session will have greater improvements in changes in body composition, including muscle mass and percent body fat versus a workout alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 20-89 years
- •Women prescribed exercise as a SOC
- •Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast
- •Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.
- •Women with > 3 months of resistance training experience under expert guidance by a CSCS
- •Must be able to read and understand English and consent for themselves.
排除标准
- •Any current treatment with cytotoxic chemotherapy for breast cancer
- •Inability to safely engage in group sessions of resistance training as deemed by study PI
- •Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training
- •Beta blocker or GLP-1 inhibitor medications
- •Pregnant women
- •Lactose intolerance
- •Cow's milk or whey protein allergy
研究组 & 干预措施
60 grams of protein
Participants will be randomized to a post-workout protein consisting of either no protein or 60 g of whey protein. The protein is 100% cold processed and micro-filtered, non-GMO grass-fed whey protein isolate, soy and gluten free, unflavored, and unsweetened. This will include Irish Dairy (AGN Roots, Ireland), which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Utilizing both will allow individuals with any sensitivity to have increased options. The powder will be weighed by EOC staff in a private room prior to mixing with 12 oz of filtered water to ensure adequate dosage. The protein will be mixed via a protein shaker bottle made of stainless steel (Bolde Bottle).
干预措施: Whey protein (60 grams) (Dietary Supplement)
0 grams of protein
Participants will be randomized to a post-workout protein consisting of either no protein or 60 g of whey protein. The protein is 100% cold processed and micro-filtered, non-GMO grass-fed whey protein isolate, soy and gluten free, unflavored, and unsweetened. This will include Irish Dairy (AGN Roots, Ireland), which is whey protein isolate and soy lecithin, and Raw GrassFed Whey, which is whey protein concentrate. Utilizing both will allow individuals with any sensitivity to have increased options. The powder will be weighed by EOC staff in a private room prior to mixing with 12 oz of filtered water to ensure adequate dosage. The protein will be mixed via a protein shaker bottle made of stainless steel (Bolde Bottle).
干预措施: No protein (Other)
结局指标
主要结局
Determine changes in pounds of muscle and fat mass after each exercise regimen
时间窗: Baseline and at program completion (within 4 weeks of exercise completion)
次要结局
- Determine changes in resting metabolic rate in calories per day at the completion of the exercise regimen(Baseline and at program completion (within 4 weeks of exercise completion))
- Determine changes in body composition at the completion of the exercise regimen, including body mass in pounds, fat mass in pounds, fat-free mass in pounds, % fat, and % fat-free mass(Baseline and at program completion (within 4 weeks of exercise completion))
- Determine changes in Y-balance score at the completion of the exercise regimen(Baseline and at program completion (within 4 weeks of exercise completion))
- Functional Movement Screen (FMS) scores at the completion of the exercise regimen(Baseline and at program completion (within 4 weeks of exercise completion))
- Determine changes in phase angle at the completion of the exercise regimen(At program completion (at 8 weeks))
研究者
Colin Champ, MD
Principal Investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)