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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03139890
Other study ID # METC 17-3-012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date September 1, 2018

Study information

Verified date September 2018
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Other:
High-fat (HF-LC-LP) milkshake
During this experimental day, men will receive a high-fat milkshake
High-carbohydrate (LF-HC-LP) milkshake
During this experimental day, men will receive a high-carbohydrate milkshake
High-protein (LF-LC-HP) milkshake
During this experimental day, men will receive a high-protein milkshake

Locations

Country Name City State
Netherlands Maastricht University Medical Center Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vascular endothelial function Flow-mediated vasodilation (FMD) of the brachial artery Change from baseline at 2 hours after milkshake consumption
Secondary Vascular function markers Carotid-femoral pulse wave velocity (PWV), pulse wave analysis (PWA), retinal microvascular caliber Change from baseline at 2 hours after milkshake consumption
Secondary Cardiometabolic risk markers Plasma markers for low-grade systemic inflammation and endothelial dysfunction Change from baseline at 2 hours after milkshake consumption
Secondary Cardiometabolic risk markers Office blood pressure During 4 hours following milkshake consumption
Secondary Postprandial metabolism Serum lipid and plasma glucose metabolism During 4 hours following milkshake consumption
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