Effect of Phytochemicals From Theobroma Cacao on Mental Energy

Study Overview
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Brief Summary
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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:

Detailed Description
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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.

Official Title
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Effect of Phytochemicals From Theobroma Cacao on Mental Energy

Conditions
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Mental Fatigue

Intervention / Treatment
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* Other: Caffeinated cocoa
* Other: Cocoa
* Other: Caffeine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women and men ages 18-34 Lower than average feelings of energy (score of < 13 on Profile of Mood States Vigor scale) Exclusion Criteria: Pregnant GI tract disorder Psychoactive medication use Daily consumption of > 200 mg caffeine Body mass index > 30 Cigarette smoker Allergy to cocoa, chocolate or caffeine Frequent consumption of cocoa, chocolate-based products or fruits and vegetable containing flavonoids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caffeinated cocoa<br>High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle | Other: Caffeinated cocoa<br>* 70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener<br>|
| Active Comparator: Cocoa<br>High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle | Other: Cocoa<br>* 21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener<br>|
| Active Comparator: Caffeine<br>Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle | Other: Caffeine<br>* 473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener<br>|
| Placebo Comparator: Placebo<br>No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle | Other: Placebo<br>* 473 ml of brewed water, caramel coloring and one packet Truvia sweetener<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct Responses on Serial 7 Subtraction Task | Participants subtract the number 7 from a three digit number and quickly and accurately as possible for 60 seconds. The total number of accurate responses is scored. The higher the score the better performance. The range of scores is from a minimum score of 0 to a theoretical maximum score of 120. | Pre and 30, 60 and 120 minutes post intervention | 
| Performance on Bakan Task | Performance on Bakan Task at baseline, post-test 1, post-test 2, and post-test 3 Bakan test presents numbers on a computer screen. Participant presses one button whenever the number 6 appears and a different button whenever three odd and different numbers in a row occurs such as 7 5 9. The number of times the participant does this correctly the better the performance. The scores range from 0 to 10 because the sequence of three odd and different numbers occurs a total of 10 times. | baseline, post 60, post 90, post 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vigor Symptoms (Profile of Mood State) | Vigor subscale scores from the Profile of Mood States.The higher the score the greater the feelings of energy. The scores range from a minimum of 0 to a maximum of 20. | Pre and 90, 120 and 160 minutes post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cacao, theobromine, flavanols, caffeine, sustained attention, vigilance, vigor, vitality, energy, fatigue