Alternating Energy Intake and Blood Fat Content After a Meal

NCT04894526 | Unknown

• 1 other identifier: METC 20-089
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Keywords

Alternating Energy Intake; Abdominal Obesity; Postprandial Lipemia; Lipid Metabolism; Glucose Metabolism

Outcome Measures

Primary Outcomes (1)

• Triacylglycerol area under the curve (AUC)

  The 4-hour AUC for triacylglycerol after consumption of a standardised mixed meal

  4 hours

Secondary Outcomes (10)

• Fasting glucose metabolism

  Baseline, week 2, and twice in week 4

• Fasting lipid metabolism

  Baseline, week 2, and twice in week 4

• Marker for postprandial lipid metabolism

  4 hour period after consumption of a standardised mixed meal

• Markers for postprandial glucose metabolism

  4 hour period after consumption of a standardised mixed meal

• 24-hour glucose levels

  24 hours

Other Outcomes (8)

• High-Sensitivity C-Reactive Protein (hs-CRP) levels

  Baseline, week 2, and twice in week 4

• Blood pressure

  Baseline, week 2, week 3, and twice in week 4

• Body weight

  Baseline, week 2, week 3, and twice in week 4

Study Arms (2)

Alternating energy intake schedule

EXPERIMENTAL

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

Other: Alternating Energy Intake

Regular energy intake schedule

ACTIVE COMPARATOR

To consume the usual energy intake on a daily basis

Other: Regular Energy Intake

Interventions

Alternating Energy Intake 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.

Alternating energy intake schedule

Regular Energy Intake 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.

Regular energy intake schedule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 ER, Netherlands

RECRUITING

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maite M. Schroor, MSc.

CONTACT

+31433884258; maite.schroor@maastrichtuniversity.nl

Ronald P. Mensink, PhD

CONTACT

+31433881308; r.mensink@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: May 20, 2021
• Study Start: July 14, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

NL (1)