To study the bioavailability of cocoa polyphenols incorporated into a food product. The food product is a soy-based drink to which cocoa powder is added. To compare the bioavailability of cocoa polyphenols incorporated either into a soy drink or…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
De uitkomsten van deze studie gaan gebruikt worden voor een geplande vervolgstudie naar het effect van cacaopolyfenolen op de bloeddruk. Deze biobeschikbaarheidsstudie heeft zelf niet op een aandoening betrekking.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Two types of body fluids will be collected, i.e. urine and blood. We will focus
in plasma on the kinetic profiles of catechins by using HPLC and LC-MS
techniques. The 24-hour urine samples contain accumulated metabolites in
relatively high concentrations. We will measure several phenolic metabolites by
using GC-MS.
Secondary outcome
The effects of cocoa polyphenols on the plasma lipid profile and glucose will
be evaluated. Total cholesterol, LDL-C, HDL-C, TG and glucose will be measured
by quantitive clinical chemical analysis using the Hitachi 912 analyzer.
Background summary
The bioavailability of particularly intact complex polyphenols has been the
subject of debate for years now. A recently published study with black tea
consumed with and without milk (**English way of drinking tea**) suggested that
even the food matrix in which the polyphenols are consumed may affect
bioavailability.
Study objective
To study the bioavailability of cocoa polyphenols incorporated into a food
product. The food product is a soy-based drink to which cocoa powder is added.
To compare the bioavailability of cocoa polyphenols incorporated either into a
soy drink or yoghurt drink and consumed during a standardised meal
To evaluate the effects of cocoa polyphenols on the plasma lipid profile and
glucose.
Study design
Placebo controlled randomised cross-over study with five treatments. The total
duration of the study is 3 weeks.
Intervention
On 5 days in the 3 weeks trial period the volunteers will randomly consume one
of five soy or yoghurt based test drinks with or without cocoa extract. At the
end of the study the volunteers will have consumed one of each test drink.
Study burden and risks
The general health of the volunteers will be determined by means of the
selection questionnaire at the screening visit, a physical examination and by
taking urine and blood samples. After volunteers are included, the volunteers
will be asked to come for 5 visits of 9 hours. Each visit starts with placing
an iv drip, which will be used to draw blood from. After drawing the first
blood sample the volunteers are asked to consume one test drink and are asked
to start collecting 24-hour urine. 8 more blood samples are drawn over the day.
The next day the urine collection vials are handed in. At each visit the
subjects will be asked to complete a questionnaire about their health and
lifestyle.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Male
Age 18-70 years
Body Mass Index (BMI) 19-30 kg/m2
Reported alcohol consumption < 28 alcohol units/week
Willing to refrain from food and foodsupplements that contain polyphenols during the study
Informed consent signed
Prepared to consume test products for the duration of the study and comply with the background diet.
Prepared to donate blood samples during the study, and prepared to fill out questionnaires.
Urine parameters within normal reference range as judged by the research physician
Clinical chemical parameters within the normal reference range as judged by research physician
Accessible veins on both arms as determined by research physician
Exclusion criteria
Females
Being an employee of the AMC
A recorded history or current metabolic diseases, chronic gastrointestinal disorders, cardiovascular or renal disease
Currently on a medically prescribed diet, or slimming diet
Reported intense sporting activities > 10 hours/week
Subjects who receive medical treatment
Any surgery in the past 6 months
Use of systemic antibiotics in the past 3 months
Recent blood donation i.e. 1 month prior to the study and no planned blood donation during the study period
Known intolerance or allergy to cocoa, soy or lactose
Reported weight change ± 10% the past 6 months
Participation in another biomedical study 3 months before the start or during the study
The habit of smoking during the past year
Consuming meat and/or fish less than twice a week
Participation in night shift work
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 | NL21194.018.08 |