Alternating Energy Intake and Blood Fat Content After a Meal

NCT ID: NCT04894526

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-14
• Study Completion Date: 2022-12-31

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.

Conditions

Abdominal Obesity; Postprandial Lipemia; Lipid Metabolism; Glucose Metabolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Alternating energy intake schedule

To alternate between caloric overconsumption and caloric underconsumption from day-to-day

Group Type: EXPERIMENTAL

Alternating Energy Intake

Intervention Type: OTHER

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 schedule

To consume the usual energy intake on a daily basis

Group Type: ACTIVE_COMPARATOR

Regular Energy Intake

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Maite M. Schroor, MSc.

Role: CONTACT

maite.schroor@maastrichtuniversity.nl

+31433884258

Ronald P. Mensink, PhD

Role: CONTACT

r.mensink@maastrichtuniversity.nl

+31433881308

Facility Contacts

Maite M. Schroor, MSc.

Role: primary

maite.schroor@maastrichtuniversity.nl

+31433884258

Other Identifiers

METC 20-089

Identifier Type: -

Identifier Source: org_study_id