Macronutrients and Postprandial Vascular Function

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Postprandial Metabolism

Macronutrients

Proteins

Dietary Fats

Vascular Function

Carbohydrates

Treatments

Other: High-carbohydrate (LF-HC-LP) milkshake

Other: High-protein (LF-LC-HP) milkshake

Other: High-fat (HF-LC-LP) milkshake

Study type

Interventional

Funder types

Other

Identifiers

NCT03139890

METC 17-3-012

Details and patient eligibility

About

Vascular function decreases following the intake of a mixed meal in some, but not all studies. Differences in the relative amounts of dietary fat, carbohydrates and protein present in the mixed-meal challenges may have contributed to these apparently inconsistent results. Well-designed trials - comparing under rigorously standardized conditions - on the effects of macronutrients on postprandial vascular function are missing. The primary objective of the current study is thus to evaluate in overweight and slightly obese men the effects of the three macronutrients (fat, carbohydrates, and protein) on postprandial vascular function, as assessed by brachial artery flow-mediated vasodilation (FMD). Secondary objectives are to examine postprandial effects on other markers reflecting vascular function, plasma markers for low-grade systemic inflammation and endothelial dysfunction, blood pressure, and serum lipid and plasma glucose metabolism.

Enrollment

20 patients

Sex

Male

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged between 18-70 years
Men
BMI between 25-35 kg/m2 (overweight and slightly obese)
Fasting plasma glucose < 7.0 mmol/L
Fasting serum total cholesterol < 8.0 mmol/L
Fasting serum triacylglycerol < 2.2 mmol/L
Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
No current smoker
No diabetic patients
No familial hypercholesterolemia
No abuse of drugs
No more than 3 alcoholic consumptions per day
Stable body weight (weight gain or loss < 3 kg in the past three months)
No use of dietary supplements known to interfere with the main study outcomes as judged by the principal investigator
No use of medication to treat blood pressure, lipid or glucose metabolism
No use of an investigational product within another biomedical intervention trial within the previous 1-month
No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
Willingness to give up being a blood donor 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

Exclusion criteria

Women
Fasting plasma glucose ≥ 7.0 mmol/L
Fasting serum total cholesterol ≥ 8.0 mmol/L
Fasting serum triacylglycerol ≥ 2.2 mmol/L
Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg
Current smoker, or smoking cessation < 12 months
Diabetic patients
Familial hypercholesterolemia
Abuse of drugs
More than 3 alcoholic consumptions per day
Unstable body weight (weight gain or loss > 3 kg in the past three months)
Use of dietary supplements known to interfere with the main study outcomes as judged by the principal investigator
Use medication to treat blood pressure, lipid or glucose metabolism
Use of an investigational product within another biomedical intervention trial within the previous 1-month
Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
Not willing to give up being a blood donor from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study
Not or difficult to venipuncture as evidenced during the screening visit