Clinical Trial: Effect of Phytochemicals From Theobroma Cacao on Mental Energy
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: 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
Detailed Summary: 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.
Sponsor: University of Georgia
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Energy and fatigue symptoms (Profile of Mood State) [ Time Frame: Pre and 90, 120 and 160 minutes post intervention ]
Original Secondary Outcome: Same as current
Information By: University of Georgia
Dates:
Date Received: July 25, 2012
Date Started: July 2012
Date Completion: June 2013
Last Updated: July 26, 2012
Last Verified: July 2012
