Back to resultsAlternating Energy Intake and Blood Fat Content After a Meal
Primary Purpose
Abdominal Obesity, Postprandial Lipemia, Lipid Metabolism
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Alternating Energy Intake
Regular Energy Intake
Sponsored by
About this trial
This is an interventional prevention trial for Abdominal Obesity focused on measuring Alternating Energy Intake, Abdominal Obesity, Postprandial Lipemia, Lipid Metabolism, Glucose Metabolism
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
Sites / Locations
- Maastricht University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Alternating energy intake schedule
Regular energy intake schedule
Arm Description
To alternate between caloric overconsumption and caloric underconsumption from day-to-day
To consume the usual energy intake on a daily basis
Outcomes
Primary Outcome Measures
Triacylglycerol area under the curve (AUC)
The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal
Secondary Outcome Measures
Fasting glucose metabolism
Fasting glucose metabolism (includes e.g. glucose and insulin concentrations)
Fasting lipid metabolism
Fasting serum lipid and lipoprotein profile
Marker for postprandial lipid metabolism
Marker for lipid metabolism includes triacylglycerol and will be measured 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
24-hour glucose levels
The total area under the curve (tAUC) for 24-hour glucose as measured with a continuous glucose sensor
Day-time glucose levels
The tAUC for day-time glucose (07:00 - 22:00 h) as measured with a continuous glucose sensor
Night-time glucose levels
The tAUC for night-time glucose (22:01 - 06:59 h) as measured with a continuous glucose sensor
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.
The mean amplitude of glycemic excursions (MAGE)
MAGE as parameter for the assessment of glycemic variability.
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).
Full Information
NCT ID
NCT04894526
First Posted
April 20, 2021
Last Updated
August 25, 2022
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04894526
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity, Postprandial Lipemia, Lipid Metabolism, Glucose Metabolism
Keywords
Alternating Energy Intake, Abdominal Obesity, Postprandial Lipemia, Lipid Metabolism, Glucose Metabolism
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alternating energy intake schedule
Arm Type
Experimental
Arm Description
To alternate between caloric overconsumption and caloric underconsumption from day-to-day
Arm Title
Regular energy intake schedule
Arm Type
Active Comparator
Arm Description
To consume the usual energy intake on a daily basis
Intervention Type
Other
Intervention Name(s)
Alternating Energy Intake
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Regular Energy Intake
Intervention Description
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.
Primary Outcome Measure Information:
Title
Triacylglycerol area under the curve (AUC)
Description
The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Fasting glucose metabolism
Description
Fasting glucose metabolism (includes e.g. glucose and insulin concentrations)
Time Frame
Baseline, week 2, and twice in week 4
Title
Fasting lipid metabolism
Description
Fasting serum lipid and lipoprotein profile
Time Frame
Baseline, week 2, and twice in week 4
Title
Marker for postprandial lipid metabolism
Description
Marker for lipid metabolism includes triacylglycerol and will be measured after consumption of a standardised mixed meal
Time Frame
4 hour period after consumption of a standardised mixed meal
Title
Markers for postprandial glucose metabolism
Description
Markers for glucose metabolism include insulin and glucose and will be measured after consumption of a standardised mixed meal
Time Frame
4 hour period after consumption of a standardised mixed meal
Title
24-hour glucose levels
Description
The total area under the curve (tAUC) for 24-hour glucose as measured with a continuous glucose sensor
Time Frame
24 hours
Title
Day-time glucose levels
Description
The tAUC for day-time glucose (07:00 - 22:00 h) as measured with a continuous glucose sensor
Time Frame
From 07:00 to 22:00 (15 hours)
Title
Night-time glucose levels
Description
The tAUC for night-time glucose (22:01 - 06:59 h) as measured with a continuous glucose sensor
Time Frame
From 22:01 to 06:59 (8 hours and 58 min)
Title
Glucose levels after main meal consumption
Description
The tAUC for glucose during 2 hours after main meal consumption (breakfast, lunch and dinner) as measured with a continuous glucose sensor.
Time Frame
2 hours
Title
The mean amplitude of glycemic excursions (MAGE)
Description
MAGE as parameter for the assessment of glycemic variability.
Time Frame
24 hours
Title
Continuous overall net glycemic action (CONGA)
Description
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).
Time Frame
1 hour, 2 hours, and 4 hours
Other Pre-specified Outcome Measures:
Title
High-Sensitivity C-Reactive Protein (hs-CRP) levels
Description
Fasting hs-CRP as inflammatory marker
Time Frame
Baseline, week 2, and twice in week 4
Title
Blood pressure
Description
Office systolic and diastolic blood pressure
Time Frame
Baseline, week 2, week 3, and twice in week 4
Title
Body weight
Description
Body weight in kilograms
Time Frame
Baseline, week 2, week 3, and twice in week 4
Title
Height
Description
Height in centimeters
Time Frame
Baseline, week 2, week 3, and twice in week 4
Title
Body Mass Index
Description
Body weight and height will be combined to report BMI in kg/m^2
Time Frame
Baseline, week 2, week 3, and twice in week 4
Title
Waist circumference
Description
Waist circumference in centimeters
Time Frame
Baseline, week 2, week 3, and twice in week 4
Title
Hip circumference
Description
Hip circumference in centimeters
Time Frame
Baseline, week 2, week 3, and twice in week 4
Title
Waist to hip ratio
Description
Waist and hip circumference will be used to report the waist to hip ratio
Time Frame
Baseline, week 2, week 3, and twice in week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maite M. Schroor, MSc.
Phone
+31433884258
Email
maite.schroor@maastrichtuniversity.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald P. Mensink, PhD
Phone
+31433881308
Email
r.mensink@maastrichtuniversity.nl
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 ER
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maite M. Schroor, MSc.
Phone
+31433884258
Email
maite.schroor@maastrichtuniversity.nl
First Name & Middle Initial & Last Name & Degree
Ronald P. Mensink, PhD
12. IPD Sharing Statement
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Alternating Energy Intake and Blood Fat Content After a Meal
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