Alternating Energy Intake and Blood Fat Content After a Meal

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Abdominal Obesity, Postprandial Lipemia, Lipid Metabolism, Glucose Metabolism

Intervention / Treatment
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* Other: Alternating Energy Intake
* Other: Regular Energy Intake


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alternating energy intake schedule<br>To alternate between caloric overconsumption and caloric underconsumption from day-to-day | Other: Alternating Energy Intake<br>* 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.<br>|
| Active Comparator: Regular energy intake schedule<br>To consume the usual energy intake on a daily basis | Other: Regular Energy Intake<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triacylglycerol area under the curve (AUC) | The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose metabolism | Fasting glucose metabolism (includes e.g. glucose and insulin concentrations) | Baseline, week 2, and twice in week 4 | 
| Fasting lipid metabolism | Fasting serum lipid and lipoprotein profile | Baseline, week 2, and twice in week 4 | 
| 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 | 
| 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 | 
| 24-hour glucose levels | The total area under the curve (tAUC) for 24-hour glucose as measured with a continuous glucose sensor | 24 hours | 
| 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) | 
| 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) | 
| 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 | 
| The mean amplitude of glycemic excursions (MAGE) | MAGE as parameter for the assessment of glycemic variability. | 24 hours | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alternating Energy Intake, Abdominal Obesity, Postprandial Lipemia, Lipid Metabolism, Glucose Metabolism