Macronutrients and Postprandial Vascular Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Meal Macronutrients on Postprandial Lipids

NCT07313787

Nephrotic Syndrome Lipodystrophy Metabolic Syndrome +3 more

NOT_YET_RECRUITING PHASE2

Study of Macronutrients and Heart Disease Risk

NCT00609271

Obesity Body Composition Blood Pressure +1 more

COMPLETED NA

Blood Lipid Responses to Diet

NCT05973539

Nutritional and Metabolic Diseases

RECRUITING NA

Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolism in Participants with Increased Cardiometabolic Risk

NCT06270901

Cardiovascular Diseases Metabolic Syndrome

COMPLETED NA

Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms

NCT05589064

Brain Injury Traumatic Mild

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dietary Fats Carbohydrates Proteins Macronutrients Vascular Function Postprandial Metabolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High-fat milkshake

Group Type EXPERIMENTAL

High-fat (HF-LC-LP) milkshake

Intervention Type OTHER

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

High-carbohydrate milkshake

Group Type EXPERIMENTAL

High-carbohydrate (LF-HC-LP) milkshake

Intervention Type OTHER

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

High-protein milkshake

Group Type EXPERIMENTAL

High-protein (LF-LC-HP) milkshake

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High-fat (HF-LC-LP) milkshake

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

Intervention Type OTHER

High-carbohydrate (LF-HC-LP) milkshake

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

Intervention Type OTHER

High-protein (LF-LC-HP) milkshake

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes