Effect of Phytochemicals From Theobroma Cacao on Mental Energy
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| First Received Date ICMJE | July 25, 2012 | ||||||||
| Last Updated Date | July 26, 2012 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Performance on tasks of sustained attention (serial subtraction, continuous performance test and Bakan task) [ Time Frame: Pre and 90, 120 and 160 minutes post intervention ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01651793 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Energy and fatigue symptoms (Profile of Mood State) [ Time Frame: Pre and 90, 120 and 160 minutes post intervention ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE |
Ratings of motivation to perform cognitive tasks [ Time Frame: Pre and 90, 120 and 160 minutes post intervention ] [ Designated as safety issue: No ] | ||||||||
| Original Other Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Phytochemicals From Theobroma Cacao on Mental Energy | ||||||||
| Official Title ICMJE | Effect of Phytochemicals From Theobroma Cacao on Mental Energy | ||||||||
| Brief Summary | The purpose of this study is to determine which substances in cocoa produces changes in mental energy. This is a double blind study. The primary outcome measures are performance on tasks of sustained attention (serial subtract, continuous performance test and Bakan task) at pre and 90, 120 and 160 minutes post intervention, energy and fatigue symptoms (profile of mood state), and ratings of motivation to perform cognitive tasks. The assigned interventions are the following: Active comparator 1 High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle Active comparator 2 High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle Active comparator 3 Low flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle Active comparator 4 Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle Inactive comparator No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle |
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| Detailed Description | Only one prior study has examined the acute influence of cocoa on mental energy. The purpose of this research is to replicate the previous observations and extend research in four ways: 1) start to determine which substance in cocoa responsible for the effect by including several comparison groups, 2) focus on individuals with average or below average symptoms of mental energy and who are not high consumers of fruits, vegetables and other products containing high amounts of flavonoids in order to learn whether people with low energy accrue a greater benefit, and 3) include additional measures of mental energy plausibly influenced by cocoa to better understand the health consequences of cocoa. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
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| Condition ICMJE | Mental Fatigue | ||||||||
| Intervention ICMJE |
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 25 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 34 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01651793 | ||||||||
| Other Study ID Numbers ICMJE | Study of cocoa-like beverages | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Patrick O'Connor, University of Georgia | ||||||||
| Study Sponsor ICMJE | University of Georgia | ||||||||
| Collaborators ICMJE | The Hershey Company | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Georgia | ||||||||
| Verification Date | July 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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