Effects of Theobromine and Caffeine on Mood, Cognition and Blood Pressure
NCT ID: NCT01288547
Last Updated: 2012-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2008-05-31
2008-07-31
Brief Summary
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Detailed Description
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Objectives: To assess mood and cognition in adult subjects after the consumption of capsules filled with 1. placebo, 2. theobromine alone, 3. caffeine alone or, 4. theobromine and caffeine combined together.
Study design: Double-blind, placebo-controlled, randomized, cross-over design, with a 1 week washout period in between.
During the 4 weeks intervention period, once a week one of the 4 types of test products were consumed with 250ml of water in a randomized order;
1. placebo capsules
2. theobromine capsules (700 mg),
3. caffeine capsules (120 mg),
4. mix of theobromine (700 mg) and caffeine (120 mg). Twenty-four healthy female subjects (and 4 reserve subjects) were recruited for a four week intervention period in total with every week a 4 hrs measurement day and one of the interventions.
Primary parameters: mood (via a Bond-Lader/ caffeine visual analogue questionnaire), cognition (Digit Symbol substitution) Secondary parameters: blood pressure
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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theobromine
theobromine (700 mg) in capsule
theobromine
700 mg theobromine in gelatin capsules given one time only
caffeine
caffeine (120 mg) in capsule
Caffeine
120 mg caffeine in capsules given one time only
Placebo capsule
no theobromine or caffeine
placebo
cellulose in capsules given one time only
theobromine + caffeine
Combined theobromine and caffeine treatment, consisting of 700 mg theobromine and 120 mg caffeine
caffeine + theobromine
120 mg caffeine and 700 mg theobromine in capsules given one time only
Interventions
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theobromine
700 mg theobromine in gelatin capsules given one time only
Caffeine
120 mg caffeine in capsules given one time only
caffeine + theobromine
120 mg caffeine and 700 mg theobromine in capsules given one time only
placebo
cellulose in capsules given one time only
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age at start of study 18 till 70 years
* Body Mass Index (BMI) between 20 and 30 kg/m2 inclusive
* Reported alcohol consumption for females \< 21
* Willing to refrain from caffeine and theobromine for 24 hours
* Apparently healthy: no reported current or previous metabolic diseases, chronic gastrointestinal disorders, cardiovascular or psychiatric disease which might effect study measurements assessed by Research physician
* willing to consume animal foods products (gelatine).
* Consumes caffeine (7 cups of either tea, cola or coffee per week minimum)
* Having a general practitioner (GP)
Exclusion Criteria
* Blood pressure above 160/90 mmHg at screening and irregular heart rate
* Using or planning to use any medically prescribed diet or weight-loss diet
* Reported intense sporting activities \> 10 h/w
* Subjects who undergoing medical treatment that may interfere with the study outcome.
* Reported weight change ± 10% during a period of 6 months prior to the study
* Reported intolerance or allergy for one of test products or standardized meal
* The habit of smoking during the past half year, drug use 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
* Not able to perform the computer tasks assessed during screening
* Reported participation in night shift work during the study period
18 Years
70 Years
FEMALE
Yes
Sponsors
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Unilever R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Yvonne Zebregs
Role: PRINCIPAL_INVESTIGATOR
Unilever R&D
Locations
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Unilever Discover
Vlaardingen, South Holland, Netherlands
Countries
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Other Identifiers
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07045V
Identifier Type: -
Identifier Source: org_study_id
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