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Completed

NCT Number: NCT03139890

Macronutrients and Postprandial Vascular Function

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-fat (HF-LC-LP) milkshake

Other

During this experimental day, men will receive a high-fat milkshake

High-carbohydrate (LF-HC-LP) milkshake

Other

During this experimental day, men will receive a high-carbohydrate milkshake

High-protein (LF-LC-HP) milkshake

Other

During this experimental day, men will receive a high-protein milkshake

Primary outcomes

  1. Vascular endothelial function

    Time frame: Change from baseline at 2 hours after milkshake consumption

    Flow-mediated vasodilation (FMD) of the brachial artery

Secondary outcomes

  1. Vascular function markers

    Time frame: Change from baseline at 2 hours after milkshake consumption

    Carotid-femoral pulse wave velocity (PWV), pulse wave analysis (PWA), retinal microvascular caliber

  2. Cardiometabolic risk markers

    Time frame: Change from baseline at 2 hours after milkshake consumption

    Plasma markers for low-grade systemic inflammation and endothelial dysfunction

  3. Cardiometabolic risk markers

    Time frame: During 4 hours following milkshake consumption

    Office blood pressure

  4. Postprandial metabolism

    Time frame: During 4 hours following milkshake consumption

    Serum lipid and plasma glucose metabolism

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effects of Macronutrients on Postprandial Vascular Function in Overweight and Slightly Obese Men

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 4, 2017
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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