Abdominal Obesity, Glucose Metabolism, Lipid Metabolism, Postprandial Lipemia
Conditions
Keywords
Alternating Energy Intake, Abdominal Obesity, Postprandial Lipemia, Lipid Metabolism, Glucose Metabolism
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.
Interventions
OTHERAlternating 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.
OTHERRegular 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.
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triacylglycerol area under the curve (AUC) | 4 hours | The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting lipid metabolism | Baseline, week 2, and twice in week 4 | Fasting serum lipid and lipoprotein profile |
| Marker for postprandial lipid metabolism | 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 |
| Markers for postprandial glucose metabolism | 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 |
| 24-hour glucose levels | 24 hours | The total area under the curve (tAUC) for 24-hour glucose as measured with a continuous glucose sensor |
| Day-time glucose levels | 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 |
| Night-time glucose levels | 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 |
| Glucose levels after main meal consumption | 2 hours | The tAUC for glucose during 2 hours after main meal consumption (breakfast, lunch and dinner) as measured with a continuous glucose sensor. |
| The mean amplitude of glycemic excursions (MAGE) | 24 hours | MAGE as parameter for the assessment of glycemic variability. |
| Continuous overall net glycemic action (CONGA) | 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). |
| Fasting glucose metabolism | Baseline, week 2, and twice in week 4 | Fasting glucose metabolism (includes e.g. glucose and insulin concentrations) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Baseline, week 2, week 3, and twice in week 4 | Body weight and height will be combined to report BMI in kg/m\^2 |
| Waist circumference | Baseline, week 2, week 3, and twice in week 4 | Waist circumference in centimeters |
| High-Sensitivity C-Reactive Protein (hs-CRP) levels | Baseline, week 2, and twice in week 4 | Fasting hs-CRP as inflammatory marker |
| Blood pressure | Baseline, week 2, week 3, and twice in week 4 | Office systolic and diastolic blood pressure |
| Body weight | Baseline, week 2, week 3, and twice in week 4 | Body weight in kilograms |
| Height | Baseline, week 2, week 3, and twice in week 4 | Height in centimeters |
| Waist to hip ratio | Baseline, week 2, week 3, and twice in week 4 | Waist and hip circumference will be used to report the waist to hip ratio |
| Hip circumference | Baseline, week 2, week 3, and twice in week 4 | Hip circumference in centimeters |
Countries
Netherlands
Contacts
Primary ContactMaite M. Schroor, MSc.
Backup ContactRonald P. Mensink, PhD
Outcome results
None listed