The FLAVO-II study will be conducted as a three-armed, randomized, cross-over intervention trial aimed at comparing the effects of chocolate and pure epicatechin on vascular function.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the acute response in Flow-Mediated Dilation (FMD) as a
marker of vascular function.
Secondary outcome
The secondary outcomes are:
- plasma and urine epicatechin concentrations
- pulse wave analysis
- plasma nitric oxide and endothelin-1 concentrations
Background summary
Decreased vascular function is a risk factor for cardiovascular disease.
Nutriton and lifestyle can significantly influence vascular function. The right
choices of foods, rich in certain nutrients, can help lower the risk of
myocardial infarction and stroke.
Foods with a high flavonoid content (such as tea, cocoa, apples and red wine)
have already been shown to improve vascular function. This effect is thought to
be due to the high-flavonoid content. Chocolate contains many types of
flavonoids, one of which is epicatechin. Results from a previous study
conducted at the Division of Human Nutrition suggest that epicaetchin can
improve vascular function. It is possible, however, that other nutritients or
components in chocolate improve the bioavailability of epicatechin resulting in
more pronounced improvements in vascular function.
During the FLAVO-II study we aim to investigate whether epicatechin from
chocolate is better absorbed than pure epicatechin (in capsule form) and if
this in turn results in more pronounced improvements in vascular function. This
will be done by asking participants to consume chocolate with varyining amounts
of epicatechin in combination with capsules with varying amounts of
epicatechin.
Study objective
The FLAVO-II study will be conducted as a three-armed, randomized, cross-over
intervention trial aimed at comparing the effects of chocolate and pure
epicatechin on vascular function.
Study design
During the FLAVO-II study, participants will attend three measurement days.
Each measurement day will be separated by two weeks. This means that the final
measurement day will take place exactly 4 weeks after the first measurement
day. Each measurement day will last 8 hours and participants will be provided
with a breakfast after 2 hours and a sandiwch at the end of the day.
During the two days prior to each measurement day, participants will be asked
to avoid consumption of flavonoid-rich foods. They will be asked to consume no
more than one cup of tea per day and to avoid consumption of cocoa, apples, red
wine and product containing onion.
Every two weeks participants will visit the university in a fasted state for a
measurement day. Fasted means that they will not be allowed to eat during the 8
hours prior to the first measurements. They will also be asked to refrain from
exercising and avoid alcohol consumption during the 24-hours prior to a
measurement day.
At each measurement day, height and weight will first be measured, ater which
the first of five blood samples will be taken. Following the blood sample,
baseline measurements of vascular function (FMD and PWA) will be done.
Hereafter participants will be asked to consume 70g of chocolate plus two
capsules. The chocolates and capsules will vary in epicatechin content.
Participants will be required to consume each combination once. At this point
subjects will also be provided with a low-flavonoid breakfast. Two hours after
consuming the chocolate, vascular function measurements will be repeated. After
consuming the chocolate, 7 blood samples of 20ml will be taken over a period of
8 hours by means of a venflon. During each measurement day, 24-hour urine
samples will be collected.
Intervention
Following baseline measurements, participants will be asked to consume 70g of
cholclate and two capsules.
The chocolates capsules will vary in epicatechin content.
Combination 1: high flavonoid chocolate (97 mg epicatechin) + capsules without
epicatechin
Combination 2: laag flavonoid chocolate + capsules with 100mg epicatechin
Combination 3: laag flavonoid chocolate + capsules without epicatechin (placebo
intervention)
Study burden and risks
There are few risks related to participation in the study. Only healthy
subjects will be allowed to participate in the study. To determine if subjects
are healthy, they will be screened on several safety parameters including
cholesterol, glucose and kidney function.
The dosage of epicatechin used during the study is equal to three times the
90th percentile of habitual intake in the Netherlands. This means that the
dosage is equivalent to what could be consumed following a flavonoid-rich diet.
A safety report for the epicatechin supplements has been provided to the METC.
Blood samples will be taken by means of a venflon which can be considered a
significant burden for the participants. Blood samples will always be taken by
trained medical staff following a standard operating procedure. In addition,
three 24-hour urine samples will be collected which can be considered a burden
for the subjects. All subjects will informed of these burdens prior to
participation in the study.
Bomenweg 2
Wageningen 6703HD
NL
Bomenweg 2
Wageningen 6703HD
NL
Listed location countries
Age
Inclusion criteria
- Age between 40 and 80 years
- BMI > 20 and <= 30
- Apparently healthy (no reported current or previous metabolic diseases, no history of cardiovascular diseases, no history of renal, liver or thyroid diseases, no history of gastrointestinal diseases, no diagnosed diabetes mellitus, fasting laboratory parameters within normal range as judged by the study physician: renal function (serum creatinine, ureum), liver function (ALAT, ASAT, *-GT), serum glucose and HDL, LDL and total cholesterol.
Exclusion criteria
• Body mass index >30 or <=20 kg/m2
• Usage of CVD medication (e.g. anti-hypertensive and/or lipid-modifying medication, non-steroidal anti-inflammatory drugs, acetylsalicylic acid), antibiotics, corticosteroids or opioids and not able or willing to stop taking them from at least 4 weeks prior to the study
• Taking nutritional supplements and unwilling to discontinue
• Reported dietary habits: medically prescribed diet, slimming diet;
• Reported average alcohol consumption >= 3 glasses/d
• Reported intense sporting activities > 10 h/w
• Weight loss or weight gain of 5 kg or more during the last 2 months
• Smokers
• Vegetarians
• Problems with consuming the supplements or following the study guidelines
• Recent blood donation (i.e. 1 month) prior to the study and/or planned donation during and shortly after the study period
• Not agreeing to be informed about unexpected and medically relevant personal test-results, or not agreeing that their general practitioner will be informed about these results
• Participation in another biomedical trial less than 2 months before the start of the study or at the same time
• No signed informed consent form
• Unable to comply with the study procedure (e.g. holidays, urine collection, blood sampling)
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 | NL48433.081.14 |