Macronutrients and Postprandial Vascular Function

September 12, 2018 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-fat milkshake
Other: High-fat (HF-LC-LP) milkshake
During this experimental day, men will receive a high-fat milkshake
Experimental: High-carbohydrate milkshake
Other: High-carbohydrate (LF-HC-LP) milkshake
During this experimental day, men will receive a high-carbohydrate milkshake
Experimental: High-protein milkshake
Other: High-protein (LF-LC-HP) milkshake
During this experimental day, men will receive a high-protein milkshake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular endothelial function
Time Frame: Change from baseline at 2 hours after milkshake consumption
Flow-mediated vasodilation (FMD) of the brachial artery
Change from baseline at 2 hours after milkshake consumption

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline at 2 hours after milkshake consumption
Cardiometabolic risk markers
Time Frame: Change from baseline at 2 hours after milkshake consumption
Plasma markers for low-grade systemic inflammation and endothelial dysfunction
Change from baseline at 2 hours after milkshake consumption
Cardiometabolic risk markers
Time Frame: During 4 hours following milkshake consumption
Office blood pressure
During 4 hours following milkshake consumption
Postprandial metabolism
Time Frame: During 4 hours following milkshake consumption
Serum lipid and plasma glucose metabolism
During 4 hours following milkshake consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • METC 17-3-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vascular Function

Clinical Trials on High-fat (HF-LC-LP) milkshake

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe