Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety

Study Overview
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Brief Summary
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Randomized, blind parallel group design. Single intake of 55 g high Epicatechin /Melissa dark chocolate containing 160 mg Epicatechin per 55 g serving or single intake of 55 g low Epicatechin/ oat bran white chocolate containing < 0,00045 mg Epicatechin per 55 g serving. A Total of 128 participants, 64 in each group, approx. equal number of male and female. There will be replacement of Drop-Outs until data from 128 participants are completed. The primary endpoints will be performance in a pictorial memory task and a verbal memory task . The secondary endpoints will be performance in a working memory test, Saliva cortisol, Visual analog scales assessing, anxiety, confidence, interference, solicitude, and excitement.

Official Title
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Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety

Conditions
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Test Anxiety

Intervention / Treatment
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* Dietary Supplement: High Epicatechin/ Melissa
* Other: Low Epicatechin/ Oat bran


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy by history normotensive (BP between 90/60 mmHg and 140/90 mmHg) BMI between 18 and < 30 kg/m2 male or female aged between 18 and 30 years native or fluent German-speaking Prüfungsangstfragebogen (PAF) total or subscale interference score T value > 60 Exclusion Criteria: Known hypersensitivity or allergy to cocoa, Melissa, oat, vanillin, milk, soja, nuts gluten intolerance lactose intolerance acute or chronic psychiatric disorder including drug or alcohol abuse women who are pregnant or breast feeding any clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease etc., infections) known or suspected non-compliance smoking (> 5 cigarettes per day) participation in one of our previous studies using the same memory tests in the past 2 years participation in a study with investigational drug within the 30 days preceding and during the present study long-term medication within last 3 months (oral contraceptives are disregarded)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Epicatechin/ Melissa<br>Single consumption of a 55g bar of dark chocolate containing: 42.8g Acticoa ® chocolate + 7.2g caster sugar + 5g Melissa containing 374 mg (-)-Epicatechin/100g chocolate and 2,69% of rosmarinic acid in Melissa leaves | Dietary Supplement: High Epicatechin/ Melissa<br>* Single consumption of a 55g bar of dark chocolate containing: 42.8g Acticoa chocolate + 7.2g caster sugar + 5g Melissa<br>|
| Placebo Comparator: Low Epicatechin/ Oat bran<br>Single consumption of a 55g bar of white chocolate containing: 50g Lindor ® chocolate + 5g oat bran containing < 0,0009 mg (-)-Epicatechin/100g | Other: Low Epicatechin/ Oat bran<br>* Single consumption of a 55g bar of white chocolate containing: 50g Lindor chocolate + 5g oat bran<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pictorial memory task | Participants will be presented with 24 neutral, 24 positive and 24 negative photographs in a random order. Scores will be calculated by summing the correctly remembered photographs per valence. | 25 minutes and 24 h after presentation | 
| Verbal memory task | Six series of five semantically unrelated nouns will be presented.Total score is calculated by summing the number of correctly recalled words | 25 minutes and 24 h after presentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saliva cortisol level | Samples are collected at different timepoints during the day in order to measure stress related cortisol activity. Participants have to chew a cotton sponge for 2-3 minutes, which then are contained in a special device | 1 day after word/picture presentation Start /middle and end of day. Baseline cortisol 1-14 days later. | 
| Working memory | Participants will have to calculate as many arithmetical means of seven one-digit numbers possible within two minutes by mental calculation. | 1 day after word/picture presentation | 
| Visual Analogue Scale VAS test anxiety | will be assessed between each task by the participant using a visual analogue scale. Respondents specify their level of agreement to the statement by indicating a position along a continuous line (10 cm). | 1 day after word/picture presentation | 
| Visual Analogue Scale VAS confidence | will be assessed between each task by the participant using a visual analogue scale. Respondents specify their level of agreement to the statement by indicating a position along a continuous line (10 cm). | 1 day after word/picture presentation | 
| Visual Analogue Scale VAS interference | will be assessed between each task by the participant using a visual analogue scale. Respondents specify their level of agreement to the statement by indicating a position along a continuous line (10 cm). | 1 day after word/picture presentation | 
| Visual Analogue Scale VAS solicitude | will be assessed between each task by the participant using a visual analogue scale. Respondents specify their level of agreement to the statement by indicating a position along a continuous line (10 cm). | 1 day after word/picture presentation | 
| Visual Analogue Scale VAS excitement | will be assessed between each task by the participant using a visual analogue scale. Respondents specify their level of agreement to the statement by indicating a position along a continuous line (10 cm). | 1 day after word/picture presentation |