NCT03527368已完成不适用
The Time-Restricted Intake of Meals Study: A Randomized, Controlled Feeding Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Weight Change
研究概览
简要总结
TRIM is a randomized, controlled feeding study to evaluate if eating earlier in the day vs. later in the day impacts weight and glucose homeostasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Prediabetes defined by HbA1c 5.7-6.4%, or type 2 diabetes with HbA1c 6.5-6.9%
- •Class I-III obesity (BMI 30-50 kg/m2)
- •If on medications for hypertension, stable regimen for at least past 6 months
- •Willingness to adjust timing of feeding
- •Willingness and ability to eat study diet and nothing else during run-in and intervention
- •Willingness to complete measurement procedures
排除标准
- •Moderate to severe obstructive sleep apnea
- •Shift work;
- •Other sleep/circadian disorders: e.g., circadian phase delay or phase advance; restless legs syndrome, insomnia, narcolepsy, habitual sleep <6 hours/night
- •Routinely ate within compressed time window in the past year (e.g., routinely eats all food within an 10-hour or narrower window, follows an intermittent fasting protocol)
- •Renal dysfunction (estimated Glomerular Filtration Rate (GFR) <30 using the simplified Chronic Kidney Disease (CKD) Epidemiology Collaboration (EPI) equation 34)
- •Use of glucose-lowering medications, weight loss medications, medications for sleep disorders (sedative/hypnotic drugs, stimulants), lithium, systemic corticosteroids, diuretics, blood thinners requiring regular monitoring (e.g. warfarin), anti-psychotic drugs and antiretroviral therapy
- •Body weight >400 pounds (limitation of facility scales)
- •>1 drink per day of alcohol
- •Active substance use disorder or significant psychiatric/psychologic disorder that would interfere with participation
- •Significant food allergies, preferences, intolerances, or dietary supplements that would interfere with diet adherence
- •Weight loss or gain of ≥5% during past 6 months
- •Pregnant, planning to become pregnant, or breastfeeding
- •Planning to start a weight loss program
- •Planning to leave the area prior to end of study
- •Current participation in another clinical trial
- •Cancer diagnosis requiring active treatment in past two years or planned treatment (with exception of localized non-melanoma skin cancer)
- •Active inflammatory bowel disease, malabsorption, or history of major gastrointestinal surgery involving bowel resection
- •Myocardial infarction or stroke in past 6 months
- •Prior bariatric surgery
- •Any serious illness that would interfere with participation
- •Other conditions or situations at the discretion of the PI
研究组 & 干预措施
Time-restricted feeding
Experimental
干预措施: Time-restricted feeding (Behavioral)
Usual feeding pattern
Other
Comparison
干预措施: Usual feeding pattern (Behavioral)
结局指标
主要结局
Weight Change
时间窗: 12 weeks
Weight change will be measured in kg
次要结局
- Fasting glucose(12 weeks)
- HOMA-IR(12 weeks)
- AUC glucose(12 weeks)
- Glycated albumin(12 weeks)
研究者
研究点 (1)
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