Alternating Energy Intake and Blood Fat Content After a Meal

Abdominal Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04894526
• Other study ID #: METC 20-089
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Obesity
• Glucose Metabolism
• Hyperlipidemias
• Lipid Metabolism
• Obesity, Abdominal
• Postprandial Lipemia

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