NCT04894526Unknown不适用
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
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Triacylglycerol area under the curve (AUC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Triacylglycerol area under the curve (AUC)
时间窗: 4 hours
The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal
次要结局
- Fasting glucose metabolism(Baseline, week 2, and twice in week 4)
- Marker for postprandial lipid metabolism(4 hour period after consumption of a standardised mixed meal)
- Continuous overall net glycemic action (CONGA)(1 hour, 2 hours, and 4 hours)
- 24-hour glucose levels(24 hours)
- Night-time glucose levels(From 22:01 to 06:59 (8 hours and 58 min))
- Day-time glucose levels(From 07:00 to 22:00 (15 hours))
- Glucose levels after main meal consumption(2 hours)
- Fasting lipid metabolism(Baseline, week 2, and twice in week 4)
- Markers for postprandial glucose metabolism(4 hour period after consumption of a standardised mixed meal)
- The mean amplitude of glycemic excursions (MAGE)(24 hours)
研究者
研究点 (2)
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