Alternating Energy Intake and Blood Fat Content After a Meal
2022年8月25日 更新者：Maastricht University Medical Center
The Effect of Alternating Energy Intake Compared to Regular Energy Intake on the Fat Content in the Blood After a Meal in Abdominally Obese Adults
Increasing evidence suggests that meal timing affects metabolic health.
For example, intermittent fasting (IF) may have positive effects on plasma glucose and lipid levels, insulin sensitivity, and blood pressure.
However, IF protocols often result in significant weight loss.
Therefore, it is not clear to what extent these beneficial metabolic effects are due to IF or to weight loss.
Although the effect of IF independent of weight loss has been studied, daily energy intake in those studies did not differ between the days.
Therefore, the investigators aim to examine the effect of alternating energy intake - i.e. standardised day-to-day fluctuations in energy intake - on metabolic health independent of weight loss.
研究概览
研究类型
介入性
注册 (预期的)
23
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Maite M. Schroor, MSc.
- 电话号码：+31433884258
- 邮箱：maite.schroor@maastrichtuniversity.nl
研究联系人备份
- 姓名：Ronald P. Mensink, PhD
- 电话号码：+31433881308
- 邮箱：r.mensink@maastrichtuniversity.nl
学习地点
-
-
Limburg
-
Maastricht、Limburg、荷兰、6229 ER
- 招聘中
- Maastricht University Medical Center
-
接触：
- Maite M. Schroor, MSc.
- 电话号码：+31433884258
- 邮箱：maite.schroor@maastrichtuniversity.nl
-
首席研究员：
- Ronald P. Mensink, PhD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Apparently healthy men and women as judged by study physician
- Abdominally obese males (waist circumference ≥ 102 cm) and females (waist circumference ≥ 88 cm)
- Aged between 18 - 75 years
- Stable bodyweight (weight gain or loss ≤ 3 kg in the past three months)
- Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visit
- Women should be pre- or postmenopausal
- Sedentary (light exercise < 1 h per week) or moderately active (moderate exercise 1-2 h per week)
- Having a general practitioner
- Agreeing that the participant and general practitioner will be informed about medically relevant personal test results by a physician
- Willing to comply to study protocol during study
- Informed consent signed
Exclusion Criteria:
- Fasting plasma glucose ≥ 7 mmol/l
- Fasting serum triacylglycerol ≥ 4.5 mmol/l
- Fasting serum total cholesterol ≥ 8 mmol/l
- Blood pressure ≥ 160/100 mm Hg
- Current smoker, or smoking cessation < 12 months
- Drug abuse
- Alcohol abuse (≥ 21 alcohol consumptions per week)
- Use of medication known to affect blood pressure, serum lipid metabolism, or glucose metabolism
- Having a medical condition or history which might impact study measurements, to be judged by the study physician (e.g. myocardial infarction, angina, thrombosis, stroke, cancer, familiar hypercholesterolemia, liver or bowel disease or diabetes)
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Use of an investigational product within another biomedical intervention trial within the previous 1-month
- Women who are perimenopausal, have an irregular menstrual cycle, or are pregnant
- Use of over-the-counter and prescribed medication, which may interfere with study measurements (to be judged by the principal investigator), e.g. weight loss medication
- Reported dietary habits: medically prescribed diets or slimming diets
- Reported participation in night shift work 2 weeks prior to screening and/or during the study. Night work is defined as working between midnight and 6.00 AM
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Alternating energy intake schedule
To alternate between caloric overconsumption and caloric underconsumption from day-to-day
|
To alternate between caloric overconsumption (130% of usual total energy needs) and caloric underconsumption (70% of usual total energy needs) on a daily basis for 6 days/week followed by one ad libitum day for 4 weeks.
|
|
有源比较器：Regular energy intake schedule
To consume the usual energy intake on a daily basis
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To consume the usual energy intake (100% of total energy needs) on a daily basis for 6 days/week, also followed by one ad libitum day for 4 weeks.
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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 |
|---|---|---|
|
Triacylglycerol area under the curve (AUC)
大体时间：4 hours
|
The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal
|
4 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fasting glucose metabolism
大体时间：Baseline, week 2, and twice in week 4
|
Fasting glucose metabolism (includes e.g.
glucose and insulin concentrations)
|
Baseline, week 2, and twice in week 4
|
|
Fasting lipid metabolism
大体时间：Baseline, week 2, and twice in week 4
|
Fasting serum lipid and lipoprotein profile
|
Baseline, week 2, and twice in week 4
|
|
Marker for postprandial lipid metabolism
大体时间：4 hour period after consumption of a standardised mixed meal
|
Marker for lipid metabolism includes triacylglycerol and will be measured after consumption of a standardised mixed meal
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4 hour period after consumption of a standardised mixed meal
|
|
Markers for postprandial glucose metabolism
大体时间：4 hour period after consumption of a standardised mixed meal
|
Markers for glucose metabolism include insulin and glucose and will be measured after consumption of a standardised mixed meal
|
4 hour period after consumption of a standardised mixed meal
|
|
24-hour glucose levels
大体时间：24 hours
|
The total area under the curve (tAUC) for 24-hour glucose as measured with a continuous glucose sensor
|
24 hours
|
|
Day-time glucose levels
大体时间：From 07:00 to 22:00 (15 hours)
|
The tAUC for day-time glucose (07:00 - 22:00 h) as measured with a continuous glucose sensor
|
From 07:00 to 22:00 (15 hours)
|
|
Night-time glucose levels
大体时间：From 22:01 to 06:59 (8 hours and 58 min)
|
The tAUC for night-time glucose (22:01 - 06:59 h) as measured with a continuous glucose sensor
|
From 22:01 to 06:59 (8 hours and 58 min)
|
|
Glucose levels after main meal consumption
大体时间：2 hours
|
The tAUC for glucose during 2 hours after main meal consumption (breakfast, lunch and dinner) as measured with a continuous glucose sensor.
|
2 hours
|
|
The mean amplitude of glycemic excursions (MAGE)
大体时间：24 hours
|
MAGE as parameter for the assessment of glycemic variability.
|
24 hours
|
|
Continuous overall net glycemic action (CONGA)
大体时间：1 hour, 2 hours, and 4 hours
|
CONGA to assess intraday glucose variability within predetermined time windows -> 1-hour interval (CONGA-1), 2-hour interval (CONGA-2), and 4-hour interval (CONGA-4).
|
1 hour, 2 hours, and 4 hours
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
High-Sensitivity C-Reactive Protein (hs-CRP) levels
大体时间：Baseline, week 2, and twice in week 4
|
Fasting hs-CRP as inflammatory marker
|
Baseline, week 2, and twice in week 4
|
|
Blood pressure
大体时间：Baseline, week 2, week 3, and twice in week 4
|
Office systolic and diastolic blood pressure
|
Baseline, week 2, week 3, and twice in week 4
|
|
Body weight
大体时间：Baseline, week 2, week 3, and twice in week 4
|
Body weight in kilograms
|
Baseline, week 2, week 3, and twice in week 4
|
|
Height
大体时间：Baseline, week 2, week 3, and twice in week 4
|
Height in centimeters
|
Baseline, week 2, week 3, and twice in week 4
|
|
Body Mass Index
大体时间：Baseline, week 2, week 3, and twice in week 4
|
Body weight and height will be combined to report BMI in kg/m^2
|
Baseline, week 2, week 3, and twice in week 4
|
|
Waist circumference
大体时间：Baseline, week 2, week 3, and twice in week 4
|
Waist circumference in centimeters
|
Baseline, week 2, week 3, and twice in week 4
|
|
Hip circumference
大体时间：Baseline, week 2, week 3, and twice in week 4
|
Hip circumference in centimeters
|
Baseline, week 2, week 3, and twice in week 4
|
|
Waist to hip ratio
大体时间：Baseline, week 2, week 3, and twice in week 4
|
Waist and hip circumference will be used to report the waist to hip ratio
|
Baseline, week 2, week 3, and twice in week 4
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年7月14日
初级完成 (预期的)
2022年12月1日
研究完成 (预期的)
2022年12月1日
研究注册日期
首次提交
2021年4月20日
首先提交符合 QC 标准的
2021年5月18日
首次发布 (实际的)
2021年5月20日
研究记录更新
最后更新发布 (实际的)
2022年8月26日
上次提交的符合 QC 标准的更新
2022年8月25日
最后验证
2022年8月1日
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.