Time-restricted Eating as a Dietary Intervention for Dyslipidemia in Peri- and Postmenopausal Women
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 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
研究组 & 干预措施
Time-restricted eating (TRE)
Participants in the TRE group are instructed to restrict eating to an 8-hr window but were not asked to change the type or amount of food typically consumed. The 8-hour window (e.g., 10am - 6pm) has to be the same each day starting at least 2 hours after wake and ending at least 2 hours before bed.
干预措施: Time-restricted eating (Behavioral)
Unrestricted eating
Participants are instructed to continue their diet as normal without changing the type, amount or timing of food typically consumed.
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 sleep duration(Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8))
- 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 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