Time-restricted Eating as a Dietary Intervention for Dyslipidemia in Peri- and Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in fasting triglyceride levels
研究概览
简要总结
The overall objective of the study is to examine the effect of an 8-hour time-restricted eating intervention on lipid levels and body composition in peri- and recently postmenopausal women with untreated dyslipidemia.
详细描述
This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to ad libitum eating (control) on metabolic health and body composition in recently postmenopausal women with untreated dyslipidemia. Following a 1-week baseline assessment, participants will be randomized to either a TRE or unrestricted control diet schedule (1-to-1 ratio) for 8 weeks. At baseline and weeks 4 and 8 of the intervention, daily eating and sleep patterns will be assessed for one week, followed by collection of fasting lipids and metabolic labs, body weight and vital signs; questionnaires assessing sleep and mood health, actigraphy and body composition via whole-body dual-energy x-ray absorptiometry will be assessed at baseline and week 8.
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
- Single (Outcomes Assessor)
盲法说明
Blood tests and assays, DXA scans, body weight, vitals, etc. are performed by assessors blinded to the condition and aims of the study.
入排标准
- 年龄范围
- 40 Years 至 58 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women aged 40-58 years
- •Perimenopausal or recently postmenopausal, >1 year and <5 years
- •BMI > 30 kg/m2
- •Dyslipidemic, defined as the presence of one or more lipid-based cardiovascular disease risk-enhancing factors per American College of Cardiology/American Heart Association guidelines
- •Normal renal and hepatic function
- •Perimenopausal women, a negative pregnancy test
排除标准
- •Dietary factors:
- •Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder
- •Concurrent dietary intervention or modification unrelated to study procedures
- •Psychiatric factors:
- •Current major depressive episode
- •Suicidal ideation
- •Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
- •Current alcohol/substance use disorder
- •Medical factors:
- •Use of lipid-lowering or lipid-enhancing medications
- •Use of systemic hormonal (estrogens and/or progestin) therapies
- •Use of weight loss medications or supplements
- •Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months
- •Previous weight loss surgery
- •Abnormal vital signs at screening visit
- •Body weight > 350 pounds, per DXA scan limits
- •Malignancy within past 2 years
- •Major surgery within past 3 months
- •Medical instability considered to interfere with study procedures
- •Contraindications to DXA scanning
- •Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas)
- •Undergoing treatment for cancer
- •Use of medications for which time-restricted eating would interfere with recommended timing of medication ingestion with food intake.
- •Lifestyle and other factors:
- •Irregular sleep/wake schedule
- •Shiftwork
- •Recent travel across 2 or more time zones
- •Recent change in exercise habits
- •Work or social schedules that would impede ability to adhere to study protocol
- •Adherence factors:
- •Inability to adhere to study procedures completed between screening and randomization visits
- •Off-Study Criteria:
- •Initiation of new medications for lipid management, weight loss, hormonal medications, or other medications that may cause changes in weight or lipid levels
- •Development of any significant medical problem
- •Enrollment in another clinical trial involving study procedures or medications that might interfere with study procedures.
- •Significant deviation from study protocol or protocol violation
- •Inability to adhere to time-restricted eating window
结局指标
主要结局
Change in fasting triglyceride levels
时间窗: Baseline (week 0) and post-intervention (week 8)
Pre- to post-intervention change in fasting triglyceride levels (mg/dL)
Change in visceral adiposity
时间窗: Baseline (week 0) and post-intervention (week 8)
Pre- to post-intervention change in visceral adiposity (mass) as measured by dual energy x-ray absorptiometry scan
次要结局
- Change in high-density lipoprotein cholesterol (HDL-C)(Baseline (week 0) and post-intervention (week 8))
- Change in depressive symptoms(Baseline (week 0) and post-intervention (week 8))
- Change in low-density lipoprotein cholesterol (LDL-C)(Baseline (week 0) and post-intervention (week 8))
- Change in sleep duration(Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8))
- Change in sleep efficiency(Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8))
- Change in systolic blood pressure(Baseline (week 0) and post-intervention (week 8))
- Change in sleep quality(Baseline (week 0) and post-intervention (week 8))
- Change in positive and negative affect(Baseline (week 0) and post-intervention (week 8))
- Change in body weight(Baseline (week 0) and post-intervention (week 8))
研究者
Leilah Kristine Grant
Investigator, Instructor in Medicine
Brigham and Women's Hospital