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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04894526
Other study ID # METC 20-089
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 14, 2021
Est. completion date December 2022

Study information

Verified date August 2022
Source Maastricht University Medical Center
Contact Maite M. Schroor, MSc.
Phone +31433884258
Email maite.schroor@maastrichtuniversity.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 23
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Other:
Alternating Energy Intake
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.
Regular Energy Intake
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.

Locations

Country Name City State
Netherlands Maastricht University Medical Center Maastricht Limburg

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other High-Sensitivity C-Reactive Protein (hs-CRP) levels Fasting hs-CRP as inflammatory marker Baseline, week 2, and twice in week 4
Other Blood pressure Office systolic and diastolic blood pressure Baseline, week 2, week 3, and twice in week 4
Other Body weight Body weight in kilograms Baseline, week 2, week 3, and twice in week 4
Other Height Height in centimeters Baseline, week 2, week 3, and twice in week 4
Other Body Mass Index Body weight and height will be combined to report BMI in kg/m^2 Baseline, week 2, week 3, and twice in week 4
Other Waist circumference Waist circumference in centimeters Baseline, week 2, week 3, and twice in week 4
Other Hip circumference Hip circumference in centimeters Baseline, week 2, week 3, and twice in week 4
Other Waist to hip ratio Waist and hip circumference will be used to report the waist to hip ratio Baseline, week 2, week 3, and twice in week 4
Primary Triacylglycerol area under the curve (AUC) The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal 4 hours
Secondary Fasting glucose metabolism Fasting glucose metabolism (includes e.g. glucose and insulin concentrations) Baseline, week 2, and twice in week 4
Secondary Fasting lipid metabolism Fasting serum lipid and lipoprotein profile Baseline, week 2, and twice in week 4
Secondary Marker for postprandial lipid metabolism Marker for lipid metabolism includes triacylglycerol and will be measured after consumption of a standardised mixed meal 4 hour period after consumption of a standardised mixed meal
Secondary Markers for postprandial glucose metabolism 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
Secondary 24-hour glucose levels The total area under the curve (tAUC) for 24-hour glucose as measured with a continuous glucose sensor 24 hours
Secondary Day-time glucose levels 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)
Secondary Night-time glucose levels 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)
Secondary Glucose levels after main meal consumption The tAUC for glucose during 2 hours after main meal consumption (breakfast, lunch and dinner) as measured with a continuous glucose sensor. 2 hours
Secondary The mean amplitude of glycemic excursions (MAGE) MAGE as parameter for the assessment of glycemic variability. 24 hours
Secondary Continuous overall net glycemic action (CONGA) 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
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