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

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

Sponsors

Lead Sponsor: Prof. Dominique de Quervain, MD

Source University of Basel
Brief Summary

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.

Overall Status Completed
Start Date 2017-12-04
Completion Date 2018-08-31
Primary Completion Date 2018-08-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Pictorial memory task 25 minutes and 24 h after presentation
Verbal memory task 25 minutes and 24 h after presentation
Secondary Outcome
Measure Time Frame
Saliva cortisol level 1 day after word/picture presentation Start /middle and end of day. Baseline cortisol 1-14 days later.
Working memory 1 day after word/picture presentation
Visual Analogue Scale VAS test anxiety 1 day after word/picture presentation
Visual Analogue Scale VAS confidence 1 day after word/picture presentation
Visual Analogue Scale VAS interference 1 day after word/picture presentation
Visual Analogue Scale VAS solicitude 1 day after word/picture presentation
Visual Analogue Scale VAS excitement 1 day after word/picture presentation
Enrollment 128
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: High Epicatechin/ Melissa

Description: Single consumption of a 55g bar of dark chocolate containing: 42.8g Acticoa chocolate + 7.2g caster sugar + 5g Melissa

Arm Group Label: High Epicatechin/ Melissa

Intervention Type: Other

Intervention Name: Low Epicatechin/ Oat bran

Description: Single consumption of a 55g bar of white chocolate containing: 50g Lindor chocolate + 5g oat bran

Arm Group Label: Low Epicatechin/ Oat bran

Eligibility

Criteria:

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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

30 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Dominique DeQuervain, Prof. MD Principal Investigator University Basel Divison of Cognitive Neuroscience
Location
Facility: University of Basel, Division of Cognitive Neuroscience
Location Countries

Switzerland

Verification Date

2018-09-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of Basel

Investigator Full Name: Prof. Dominique de Quervain, MD

Investigator Title: Prof. Dominique de Quervain, MD

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: High Epicatechin/ Melissa

Type: Active Comparator

Description: 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

Label: Low Epicatechin/ Oat bran

Type: Placebo Comparator

Description: Single consumption of a 55g bar of white chocolate containing: 50g Lindor ® chocolate + 5g oat bran containing < 0,0009 mg (-)-Epicatechin/100g

Acronym MaRS-Basel
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: Double (Investigator, Outcomes Assessor)

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