The primary objective of the proposed study is to evaluate the effect of the three macronutrients on postprandial vascular function, assessed by brachial artery flow-mediated vasodilation (FMD), in overweight and slightly obese male volunteers.…
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measurements will be performed before and two hours after consumption of the
milkshakes. The primary endpoint is the difference in postprandial change in
FMD between the HF-LC-LP, LF-HC-LP and LF-LC-HP meal.
Secondary outcome
Secondary outcomes are the postprandial effects of a HF-LC-LP, LF-HC-LP and
LF-LC-HP meal on other markers reflecting vascular function (PWA, PWV and
retinal microvascular caliber), plasma markers for low-grade systemic
inflammation and endothelial dysfunction, blood pressure, and serum lipid and
plasma glucose metabolism.
Background summary
Vascular function may decrease 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 effects of macronutrients on
postprandial vascular function are missing.
Study objective
The primary objective of the proposed study is to evaluate the effect of the
three macronutrients on postprandial vascular function, assessed by brachial
artery flow-mediated vasodilation (FMD), in overweight and slightly obese male
volunteers. 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 design
The proposed study will have a randomized, double-blind cross-over design. The
total study duration will be at least 15 days, including three test days, each
separated by a washout period of at least 1 week.
Intervention
During each of the three experimental days, the volunteers will participate in
a postprandial test. For this, they receive in random order a high-fat
(HF-LC-LP) milkshake, high-carbohydrate (LF-HC-LP) milkshake or high-protein
(LF-LC-HP) milkshake. The total follow-up during each of the postprandial tests
is 4 hours.
Study burden and risks
Subjects will be screened to determine eligibility during one visit of 15
minutes. During these screening visits, anthropometric measurements will be
performed and blood pressure will be determined. In addition, a venous blood
sample (9.0 mL) will be drawn. During the study, there will be three test days
in which subjects receive in random order a HF-LC-LP milkshake, a LF-HC-LP
milkshake or a LF-LC-HP milkshake. There are no directs benefits for the
participants. Investigational products are safe and all ingredients to prepare
the milkshakes are commercially available and approved for human consumption.
There are no side effects related to the consumption of the milkshakes. On the
experimental days a postprandial test will take place and blood will be sampled
(3 x 105.0 mL with an interval of at least one week inter-between). During the
4-hour postprandial period, participants are allowed to drink one glass of
water and are free to walk-around. Some study subjects may report pain during
venipuncture. Insertion of the cannula can cause some discomfort and possible a
hematoma or bruise. Some men may also report pain during the insertion of the
cannula. Vascular measurements will be performed before and two hours after
meal intake. These measurements are routine and not expected to lead to
physical side effects. Study participants that not fully adhere to the study
protocol will be excluded from the statistical analyses because a per protocol
analysis will be performed. Time investment is approximately 15 hours,
excluding travel time.
Universiteitsingel 50
Maastricht 6229 ER
NL
Universiteitsingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
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 medication known 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 medication known 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60030.068.17 |