Effects of Theobromine and Caffeine on Mood, Cognition and Blood Pressure
| Tracking Information | |||||
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| First Received Date ICMJE | January 31, 2011 | ||||
| Last Updated Date | February 22, 2012 | ||||
| Start Date ICMJE | May 2008 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mood and cognition [ Time Frame: 3 hrs every week for 4 weeks ] [ Designated as safety issue: No ] Bond Lader Visual Analogue Scale Digit Symbol Substitution Caffeine Negative Symptoms |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01288547 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
blood pressure and heart rate [ Time Frame: 3 hrs every week for 4 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Theobromine and Caffeine on Mood, Cognition and Blood Pressure | ||||
| Official Title ICMJE | Temporal Change of Mood and Cognition in Healthy Subjects After Consumption of Theobromine and/ or Caffeine | ||||
| Brief Summary | The purpose of this study was to measure potential mood, cognition and blood pressure effects of theobromine and caffeine in healthy women |
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| Detailed Description | Background Previous research has shown that naturally occurring chocolate ingredients theobromine and caffeine have positive effects on mood. 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;
Primary parameters: mood (via a Bond-Lader/ caffeine visual analogue questionnaire), cognition (Digit Symbol substitution) Secondary parameters: blood pressure |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
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| Condition ICMJE | Mood | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 24 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01288547 | ||||
| Other Study ID Numbers ICMJE | 07045V | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Unilever R&D | ||||
| Study Sponsor ICMJE | Unilever R&D | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Unilever R&D | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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