Time Restricted Eating on the Microbiome Affecting Metabolic Health and Bone in Older Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
In the Time-Restricted Eating: Microbiome and Bone (TREMBO) study, the primary goal is to determine the effect of time-restricted eating with caloric restriction compared to caloric restriction alone on bone health, as well as body weight and the gut microbiota in older women who are overweight or obese.
详细描述
Time-restricted eating (TRE) has gained increased attention due to the possibility to induce weight loss and improve cardiometabolic health as a result of the purported alignment of circadian rhythm. However, since TRE is often reported to cause a spontaneous reduction of calories, it is not well understood if these health benefits are due to weight loss, circadian rhythm alignment, or a combination of the two. Furthermore, while weight loss can improve cardiometabolic health, it can also induce bone loss, which is problematic in older women who are at a higher risk of fracture. Interestingly, both bone turnover and the gut microbiota are responsive to diurnal variations, such as meal timing, and alterations in the gut microbiota have been associated with differences in bone health. In rodent models, caloric restriction can alter the gut microbiota composition with further alterations shown due to time-restricted eating. This suggests that time-restricted eating could affect bone health, which may be partially mediated by changes in the gut microbiota. Also, lifestyle patterns affects both the microbiota and bone. This randomized controlled trial will use behavior modification to examine TRE plus caloric restriction (CR) to achieve an evening energy deficit compared to CR alone on bone health, as well as body weight and the gut microbiota in older women who have overweight or obese.
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
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women (>2 years since last menses)
- •Body mass index (25-45 kg/m2)
- •Agree to be randomly assigned to consume food for ≤ 9 hours/day or ≥12 hours/day
- •Must attend on-site visits (about 10) in New Brunswick, NJ, USA (transportation/reimbursement for travel not included)
排除标准
- •Participants with >5% weight loss in the past 6 months or extreme dietary/physical activity habits
- •An inability to follow the experimental intervention or to perform the required specimen collections
- •Antibiotic use in the past 2 months
- •Current diagnosis, or history of cancer in past 3 years
- •History of surgical procedure for weight loss in the past 3 years
- •Current diagnosis or history of bone diseases, type I or II diabetes, gastrointestinal disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, cardiac, or renal disease
- •Uncontrolled hypertension or hyperlipidemia in abnormal ranges
- •Regular use of medications that affect bone metabolism, including bisphosphonates or hormone replacement.
- •A colonoscopy within the past 2 months
- •Alcohol or illicit drug abuse
- •Current smoker or having quit smoking in the past 3 months
- •Shift work
- •Participation in another clinical research trial which may interfere with the results of this study.
研究组 & 干预措施
Time restricted eating and calorie restriction
Subjects will be asked to adhere to a calorie-restricted diet and will be counseled by a dietitian for diet and lifestyle behavior education. In addition, they will be asked to only consume calories during a 9-hour window (15:9).
干预措施: Calorie Restriction (Behavioral)
Calorie restriction alone
Subjects will be asked to adhere to a calorie-restricted diet and will be counseled by a dietitian for diet and lifestyle behavior education. They will be advised to continue to consume foods throughout the day and into the evening.
干预措施: Calorie Restriction (Behavioral)
Time restricted eating and calorie restriction
Subjects will be asked to adhere to a calorie-restricted diet and will be counseled by a dietitian for diet and lifestyle behavior education. In addition, they will be asked to only consume calories during a 9-hour window (15:9).
干预措施: Time Restricted Eating (TRE) (Behavioral)
结局指标
主要结局
Weight loss
时间窗: change from baseline to an average 6 months
Body weight in kg
Microbiota
时间窗: change from baseline to an average 6 months
stool
Bone mineral density (BMD - hip)
时间窗: change from baseline to an average 6 months
dual energy x-ray absorptiometry
次要结局
- Trabecular bone (volumetric BMD, bone volume / total volume, and separation)(change from baseline to an average 6 months)
- Blood pressure (systolic and diastolic)(change from baseline to an average 6 months)
- Insulin - response to oral glucose tolerance test(change from baseline to an average 6 months)
- Soft tissue (lean and fat mass)(change from baseline to an average 6 months)
- Areal BMD (lumbar spine, femoral neck, radius, total body)(change from baseline to an average 6 months)
- Cortical bone (volumetric BMD, thickness, and porosity) and total BMD(change from baseline to an average 6 months)
- Glucose - response to oral glucose tolerance test(change from baseline to an average 6 months)
- Areal BMD (radius, lumbar spine)(change from baseline to an average 6 months)
- Gut Microbiota(change from baseline to an average 6 months)
- Weight loss(change from baseline to an average 6 months)
- Soft tissues(change from baseline to an average 6 months)
- Trabecular bone(Change from baseline to an average 6 months)
- Cortical (Ct) bone(change from baseline to an average 6 months)
研究者
Sue A. Shapses, Ph.D., RD
Professor
Rutgers, The State University of New Jersey