Effects of Time-restricted Eating on Nutrient Absorption in Healthy Adults
研究概览
详细说明
The obesity epidemic is well documented, and despite a complex etiology influenced by genetic, physiological, psychological, social, behavioral, and environmental factors, obesity seems to be the result of energy imbalance, where energy intake exceeds energy expenditure, regardless of the internal and external influences. Studies aiming to quantify and manipulate modulators of energy balance, including gastrointestinal (GI) energy absorption rates (i.e., digestibility), are crucial for reducing the incidence of overweight and obesity and improving overall human health. Despite considerable interindividual variability in the amount of ingested energy that is absorbed (~87-98% of ingested energy) by the gastrointestinal tract, generalized equations are used to calculate individual energy intake requirements, and the factors that contribute to such variability, including meal-timing, are largely unknown.
The proposed study seeks to determine the effects of restricting the eating window to 6-h (early time-restricted eating) as compared to a control eating window of 12 h on energy and macronutrient digestibility, thermic effect of food (TEF), postprandial blood metabolites (triglyceride, insulin, glucose, fructose, galactose, inositol, and sorbitol), 24 h glucose concentrations and glycemic variability, intestinal hydrogen gas production, microbiome composition, and gastrointestinal transit time in response to a controlled, energy balanced diet. In addition, this project will determine whether energy digestibility can be predicted from biological and physiological factors such as gut microbiota composition, gastrointestinal transit time, 24-h glucose concentrations, and postabsorptive and postprandial metabolomic profiles.
Participants will be randomized to early TRE (6-h feeding window, 8am-2pm) or a control eating schedule (12-h feeding window, 8am-8pm) and consume a controlled, energy balance diet (breakfast, lunch, dinner, snacks, and beverages) for 9 consecutive days before crossing over to the other intervention after at least a 3-wk washout for females (to control for hormonal fluctuations) and at least a 2-wk washout for males. Participants will collect stool and urine during each feeding phase. Gross energy content (heat combustion by bomb calorimetry) of the diet, stool, and urine samples will be used to calculate energy digestibility (diet gross energy - stool gross energy) and metabolizable energy. Factors that may mediate and/or predict energy digestibility efficiency, including gastrointestinal microbial composition, transit time, and gas production, fasting and postprandial metabolites, continuous glucose concentrations, and thermogenesis will be assessed.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Florida
-
Tallahassee、Florida、美国、32306
- Florida State University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 20-45 years old
- Normal weight or overweight (18.5 to 29.9 kg/m2)
- Not taking any probiotics for 4 weeks prior to and throughout the entire study
- Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use throughout the study
- Willing to consume a controlled diet for 9 consecutive days on 2 different occasions (18 days total) and collect all urine and fecal output for 3-5 days during each occasion
- Pass the blue dye gastrointestinal tracer (given at screening) within 72 hours of administration
Exclusion Criteria:
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders, prior bariatric surgery, malabsorption, or any condition that interferes with metabolism (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
- Suspected or known strictures, fistulas, or physiological/mechanical gastrointestinal obstruction
- Present condition of alcoholism, anabolic steroids, or other substance abuse issues
- Women who are pregnant, lactating, planning to become pregnant, or who have an irregular menstrual cycle in the past 6 months
- Weight fluctuations ± 5% of body weight in the last 6 months
- Allergies or intolerance to foods included in the controlled diet
- Any use of antibiotics, except topical antibiotics, within 3 months of study participation
- Colonoscopy within 3 months of study participation
- Use of laxatives, stool softeners, or anti-diarrheal medications more than once a week within 4-weeks of study enrollment
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：early time-restricted eating (eTRE)
Participants will be provided a weight-maintenance diet for 9 consecutive days and will consume all meals and snacks in a 6-h window in the morning hours (e.g., 8:00 AM - 2:00 PM)
|
A diet meeting the participant's weight maintenance energy needs will be provided.
|
|
实验性的：control eating schedule (CON)
Participants will be provided a weight-maintenance diet for 9 consecutive days and will consume all meals and snacks in a 12-h window in the morning hours (e.g., 8:00 AM - 8:00 PM)
|
A diet meeting the participant's weight maintenance energy needs will be provided.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Energy digestibility
大体时间：Days 4-9
|
Calculated as gross energy of the diet (kcals) - gross energy excreted in stool (kcals)
|
Days 4-9
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fat digestibility
大体时间：Days 4-9
|
Calculated as fat content of the diet - fat content excreted in stool
|
Days 4-9
|
|
Carbohydrate digestibility
大体时间：Days 4-9
|
Calculated as carbohydrate content of the diet - carbohydrate content excreted in stool
|
Days 4-9
|
|
Protein digestibility
大体时间：Days 4-9
|
Calculated as protein content of the diet - protein content excreted in stool
|
Days 4-9
|
|
Metabolizable energy
大体时间：Days 4-9
|
Calculated as gross energy of the diet (kcals) - gross energy excreted in urine and stool (kcals)
|
Days 4-9
|
|
Metabolizable protein
大体时间：Days 4-9
|
Calculated as protein content of the diet - protein excreted in urine and stool
|
Days 4-9
|
|
Postabsorptive and postprandial plasma metabolites
大体时间：Day 6
|
Plasma metabolites will be measured using gas chromatography coupled with mass spectrometry in the postabsorptive state and following a standardized meal (1 hour, 2 hours, 3 hours, and 4 hours after meal intake).
|
Day 6
|
|
Gut microbiome
大体时间：Day 6
|
Microbiota composition and diversity will be determined using 16S rRNA gene sequencing.
|
Day 6
|
|
Gastrointestinal transit time
大体时间：Day 6
|
A gas-sensing capsule will be ingested to measure transit time in the gastrointestinal tract.
|
Day 6
|
|
Gastrointestinal gas production
大体时间：Day 6
|
A gas-sensing capsule will be ingested to measure hydrogen, carbon dioxide, and oxygen production in the gastrointestinal tract.
|
Day 6
|
|
Gastrointestinal temperature
大体时间：Day 6
|
A gas-sensing capsule will be ingested to measure temperature in the gastrointestinal tract.
|
Day 6
|
|
24-h glucose concentrations
大体时间：Days 1-8
|
A continuous glucose monitor will be used to collect and assess 24-h glucose concentrations.
|
Days 1-8
|
|
24-h glucose variability
大体时间：Days 1-8
|
A continuous glucose monitor will be used to collect and assess 24-h glucose variability.
|
Days 1-8
|
|
Thermic effect of food
大体时间：Day 6
|
Indirect calorimetry measures will be collected in the resting state and for 4 hours (15-30, 45-60, 75-90, 105-120, 165-180, and 225-240 minutes) following the consumption of a standardized meal.
|
Day 6
|
合作者和调查者
调查人员
- 首席研究员：Claire E Berryman, Ph.D.、Florida State University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.