Effect of One Day Early Time-Restricted Eating (eTRE) on Appetite, Appetite-Regulatory Hormones and Energy Intake in Healthy Men Without Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Total Peptide-YY (PYY)
研究概览
简要总结
This randomised crossover study's primary aim is to investigate the effect of short-term fasting (eTRE) on subjective appetite and appetite-regulatory hormones (i.e., leptin, adiponectin, total glucagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide (GIP), total peptide YY (PYY), acylated ghrelin and Insulin). In addition, to examine if the one-day early time-restricted eating influences energy expenditure and ad libitum energy intake in the periods following the standard meal test. The researchers will compare normal eating with early Time-Restricted Eating (eTRE) in healthy men.
详细描述
Screening visit At the screening visit, the participant will firstly meet with a researcher involved in the study. They will then be directed to the laboratory before being asked to sign the informed consent form followed by the Health Screening questionnaire. Further, participants will have height and weight measured by a researcher, and BMI will be subsequently calculated. Those who are eligible to participate will be enrolled in the trial and will be invited for two experimental trials.
Those participants who are eligible will be asked to complete the International Physical Activity Questionnaire, to assess physical activity levels, a food preferences scale to examine how much they like the foods provided during experimental trials, and (should participants be eligible) participants will be provided with a food diary and scales that they must complete the day before their first and second experimental trials. Detailed instructions will be provided to participants on how to appropriately complete the food diary using the food scales.
Before experimental trials Participants will be instructed to complete two primary tasks prior to the experimental trials. First, participants will complete or follow a food diary. Specifically, 24 hours before the 2-day experimental trials, participants will complete a food diary, weighing and recording all food and beverage consumption. This is to ensure food and beverage intake is standardised in the 24 hours before the first experimental trial. Participants will also be instructed to fast from 20:30 the night before experimental trials.
Experimental trials Day 1 Participants will attend the lab at approximately 08:00 am. Participants will be fasting from 20:30 from the previous night (i.e., 12 hours without food or drink, except water). Once participants arrive, their weight will be recorded by a researcher, and they will rest until 09:00.
Normal diet In the normal diet experimental trial, the researcher will provide the standardised breakfast meal to participants at approximately 9:00 am. They will have 30 minutes to consume the meal. After this, participants will then rest in the metabolic research unit for the remaining 5.5 hours of the trial and will be allowed to work on laptops/tablets and relax in the metabolic research unit at the end of the trial (approximately 15:00; 7-hour trial in total), following a period of rest, they will then, at approximately 15:00, they will consume a standardised lunch, which they will have 30 minutes to consume. They will collect the standardised dinner to consume at home between 20:00 and 21.00 pm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged 18 years or older.
- •BMI between 18.5 and 24.9 kg/m²
- •Have stable body mass for at least three months (within ±2 kg).
排除标准
- •People who are younger than 18 or older than 65 years old.
- •Following a special diet (e.g. weight loss, vegetarian or vegan, etc.).
- •Have food allergies related to the study.
- •Taking any medications.
- •Suffering from metabolic health issues, e.g., history of diabetes, cardiovascular disease, or eating disorders.
研究组 & 干预措施
The normal diet experimental trial
The participants will attend the lab in a fast state. They will have three meals in 12 hours, each providing 33% of their estimated energy needs.
干预措施: Normal diet (Dietary Supplement)
The normal diet experimental trial
The participants will attend the lab in a fast state. They will have three meals in 12 hours, each providing 33% of their estimated energy needs.
干预措施: instantaneous visual analogue scale (iVAS) (Other)
The eTRE diet experimental trial
The participants will attend the lab in a fast state. They will have three meals in 16 hours, each providing 33% of their estimated energy needs.
干预措施: early Time-Restricted Eating (eTRE) (Dietary Supplement)
The eTRE diet experimental trial
The participants will attend the lab in a fast state. They will have three meals in 16 hours, each providing 33% of their estimated energy needs.
干预措施: instantaneous visual analogue scale (iVAS) (Other)
结局指标
主要结局
Change in Total Peptide-YY (PYY)
时间窗: At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.
The researchers will draw blood samples on day 2, at different time points during the trial, to measure the change in PYY levels. The area under the plasma concentration versus time curve (AUC) of PYY will be calculated using the trapezoidal rule.
Change in Acylated Ghrelin
时间窗: At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.
The researchers will draw blood samples on day 2, at different time points during the trial to measure changes in acylated ghrelin levels. The area under the plasma concentration versus time curve (AUC) of acylated ghrelin will be calculated using the trapezoidal rule.
Change in Glucagon-Like Peptide-1 (GLP-1)
时间窗: At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.
The researchers will draw blood samples on day 2, at different time points during the trial to measure the change in GLP-1 blood levels. Area under the plasma concentration versus time curve (AUC) of GLP-1 will be calculated using the trapezoidal rule.
Change in Leptin
时间窗: At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.
The researchers will draw blood samples on day 2, at different time points during the trial to measure the change in Leptin levels. The area under the plasma concentration versus time curve (AUC) of Leptin will be calculated using the trapezoidal rule.
Change in Adiponectin
时间窗: At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.
The researchers will draw blood samples on day 2, at different time points during the trial to measure changes in Adiponectin levels. The area under the plasma concentration versus time curve (AUC) of Adiponectin will be calculated using the trapezoidal rule.
Change in Gastric inhibitory polypeptide (GIP)
时间窗: At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.
The researchers will draw blood samples on day 2, at different time points during the trial to measure changes in GIP levels. The area under the plasma concentration versus time curve (AUC) of GIP will be calculated using the trapezoidal rule.
Change in Insulin
时间窗: At 0 (fast baseline), 0.5, 1, 2, and 3 hours after standardised breakfast.
The researchers will draw blood samples on day 2, at different time points during the trial to measure the change in Insulin levels. The area under the plasma concentration versus time curve (AUC) of Insulin will be calculated using the trapezoidal rule.
Change in subjective appetite sensations
时间窗: Will take place seven times over a two-hour period in Day1 and nine times in Day2 at 0 (baseline), 0.5, 1, 2, 3, 4, 5, 6 and 7 hours.
The researchers will assess the subjective appetite sensations using 100 mm visual analog scales (VAS) to measure appetite sensations (hunger, satiety, fullness, prospective food consumption, and desire to eat). The VAS are 100 mm long, with words anchored at each end expressing the most positive and negative ratings. Scores for each appetite construct range from 0-100.
次要结局
- Energy Intake(At 24 hours)
研究者
James Dorling, PhD
Lecturer in Human Nutrition, Principal Investigator
University of Glasgow