Clinical trial NCT04894526: Alternating Energy Intake and Blood Fat Content After a Meal
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Obesity
Postprandial Lipemia
Lipid Metabolism
Glucose Metabolism
Keywords: Alternating Energy Intake
Abdominal Obesity
Postprandial Lipemia
Lipid Metabolism
Glucose Metabolism
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Triacylglycerol area under the curve (AUC)
timeFrame: 4 hours
Secondary outcomes:
measure: Fasting glucose metabolism
timeFrame: Baseline, week 2, and twice in week 4
measure: Fasting lipid metabolism
timeFrame: Baseline, week 2, and twice in week 4
measure: Marker for postprandial lipid metabolism
timeFrame: 4 hour period after consumption of a standardised mixed meal
measure: Markers for postprandial glucose metabolism
timeFrame: 4 hour period after consumption of a standardised mixed meal
measure: 24-hour glucose levels
timeFrame: 24 hours
measure: Day-time glucose levels
timeFrame: From 07:00 to 22:00 (15 hours)
measure: Night-time glucose levels
timeFrame: From 22:01 to 06:59 (8 hours and 58 min)
measure: Glucose levels after main meal consumption
timeFrame: 2 hours
measure: The mean amplitude of glycemic excursions (MAGE)
timeFrame: 24 hours
measure: Continuous overall net glycemic action (CONGA)
timeFrame: 1 hour, 2 hours, and 4 hours
Other outcomes:
measure: High-Sensitivity C-Reactive Protein (hs-CRP) levels
timeFrame: Baseline, week 2, and twice in week 4
measure: Blood pressure
timeFrame: Baseline, week 2, week 3, and twice in week 4
measure: Body weight
timeFrame: Baseline, week 2, week 3, and twice in week 4
measure: Height
timeFrame: Baseline, week 2, week 3, and twice in week 4
measure: Body Mass Index
timeFrame: Baseline, week 2, week 3, and twice in week 4
measure: Waist circumference
timeFrame: Baseline, week 2, week 3, and twice in week 4
measure: Hip circumference
timeFrame: Baseline, week 2, week 3, and twice in week 4
measure: Waist to hip ratio
timeFrame: Baseline, week 2, week 3, and twice in week 4
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
References: