Clinical trial NCT03139890: Macronutrients and Postprandial Vascular Function
Official title: The Effects of Macronutrients on Postprandial Vascular Function in Overweight and Slightly Obese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Fats
Carbohydrates
Proteins
Macronutrients
Vascular Function
Postprandial Metabolism
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Vascular endothelial function
timeFrame: Change from baseline at 2 hours after milkshake consumption
Secondary outcomes:
measure: Vascular function markers
timeFrame: Change from baseline at 2 hours after milkshake consumption
measure: Cardiometabolic risk markers
timeFrame: Change from baseline at 2 hours after milkshake consumption
measure: Cardiometabolic risk markers
timeFrame: During 4 hours following milkshake consumption
measure: Postprandial metabolism
timeFrame: During 4 hours following milkshake consumption
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Peter J Joris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gravesteijn E, Mensink RP, Smeets ETHC, Plat J. Dietary Macronutrients Do Not Differently Influence Postprandial Serum and Plasma Brain-Derived Neurotrophic Factor Concentrations: A Randomized, Double-Blind, Controlled Cross-Over Trial. Front Neurosci. 2021 Dec 21;15:774915. doi: 10.3389/fnins.2021.774915. eCollection 2021.
citation: Schroor MM, Plat J, Konings MCJM, Smeets ETHC, Mensink RP. Effect of dietary macronutrients on intestinal cholesterol absorption and endogenous cholesterol synthesis: a randomized crossover trial. Nutr Metab Cardiovasc Dis. 2021 May 6;31(5):1579-1585. doi: 10.1016/j.numecd.2021.01.010. Epub 2021 Jan 29.
citation: Smeets ETHC, Mensink RP, Joris PJ. Dietary macronutrients do not differently affect postprandial vascular endothelial function in apparently healthy overweight and slightly obese men. Eur J Nutr. 2021 Apr;60(3):1443-1451. doi: 10.1007/s00394-020-02340-y. Epub 2020 Jul 29.