To investigate the effect of two different dosages of theobromine and caffeine (450 mg theobromine and 60 mg caffeine and 300 mg theobromine and 40 mg caffeine respectively) and placebo on mood and cognition in healthy subjects.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
stemming en cognitie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Explicit and implicit mood
Concentration and attention
Secondary outcome
Blood pressure
Personality scores
Background summary
Theobromine and caffeine are both stimulants. Theobromine is less potent, but
it also causes less negative side effects, like headaches and jitteryness.
A previous Unilever study compared the effects from caffeine and theobromine
alone as well as a combination of both on mood and cognition. Caffeine and
theobromine combined resulted in positive mood effects as well as increased
task engagement.
This previous study was a proof-of-principle study with high doses of
ingredients. The current study will use smaller doses closer to what is found
in a serving of dark chocolate. Only combinations of theobromine and caffeine
will be tested. In addition, the test battery differs from the one that has
been used befire.
Study objective
To investigate the effect of two different dosages of theobromine and caffeine
(450 mg theobromine and 60 mg caffeine and 300 mg theobromine and 40 mg
caffeine respectively) and placebo on mood and cognition in healthy subjects.
Study design
Study has a doubleblind, randomized, cross-over design. Duration is 3 weeks
with a one-week wash-out in between measurement days.
Each subject will consume all three testproducts in a random order: (1)
combination of theobromine (450 mg) and caffeine (60 mg), (2) theobromine (300
mg) and caffeine (40 mg) and (3) placebo. Each condition consists of 4
capsules. Capsules will be consumed with 250 ml of water.
There will be three measurement days, on which subjects need to be present at
the consumer center. On each measurement day they will take one of the
treatments, fill in several questionnaires, and perform several computer tests.
In addition, blood pressure will be measured twice (see E4).
Intervention
3 different conditions
1. Placebo: 4 x capsules filled with Avicel PH-101, Ph Eur (Fluka)
2. High theobromine (450 mg) and caffeine (60 mg): 3 x capsule with theobromine
(150 mg) + 1 x capsule with caffeine (60 mg)
3. Low theobromine (300 mg) and caffeine (40 mg): 2 x capsule with theobromine
(150 mg) + 1 x capsule with caffeine (40 mg) + 1 placebo capsule.
All capsules are filled to the same volume so that all appear equal. The
gelatin capsules (size 0 or 1) will be produced by Metagenics (Belgium).
Study burden and risks
No medical or health risks are expected. However, subjects could report
caffeine withdrawal effects.
Olivier van Noortlaan 120
3133 AT Vlaardingen
Nederland
Olivier van Noortlaan 120
3133 AT Vlaardingen
Nederland
Listed location countries
Age
Inclusion criteria
Age at start of the study >= 18 and <= 55 years
Being female
Body mass index (BMI) >= 18.5 and <= 30.0 kg/m2.
Reported alcohol consumption < 14 alcohol units/week
Agreeing to be informed about medically relevant personal test-results
Informed consent signed
Willing to refrain from caffeine and theobromine for 28 hours, from 8 p.m. on the day prior to the measurement day until the end of the measurement day (0:00 - midnight)
Apparently healthy: no reported current or previous diseases or disorders which might effect study measurements assessed by Research physician
Consuming animal foods products (gelatine).
Consumes dark chocolate at least once in a month
Having a general practitioner (GP)
Exclusion criteria
Being an Unilever employee
Consumes more than 250 mg caffeine daily
Using or planning to use any medically prescribed diet or weight-loss diet or making any attempt to control diet at screening and during the entire study.
Reported intense sporting activities > 10 h/w
Subjects who undergoing medical treatment that may interfere with the study outcome.
Use of systemic antibiotics in the period of 3 months prior to the study
Reported participation in another biomedical study 1 month before the start or during the study.
Reported intolerance or allergy for one of test products or standardized meal
The habit of smoking during the past half year or using nicotine containing medicines during the past month
Reported lactating (or lactating < 6 weeks ago), pregnant (or pregnant < 3 months ago) or wish to become pregnant during the study
Office systolic blood pressure > 160 mmHg and/ or diastolic blood pressure > 95 mmHg, irregular heart rate and/or heart rate > 100 bpm. Eligibility of subjects with a heart rate <56 bpm will be assessed by the research physician
Not able to perform the computer tasks assessed during screening
Reported participation in night shift work during the study period
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 | NL27096.081.09 |