Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety (MaRS-Basel)

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.

Study Overview

• Status: Completed
• Conditions: Test Anxiety
• Intervention / Treatment: Dietary supplement: High Epicatechin/ Melissa; Other: Low Epicatechin/ Oat bran

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4055
    • University of Basel, Division of Cognitive Neuroscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High Epicatechin/ Melissa; 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; Single consumption of a 55g bar of dark chocolate containing: 42.8g Acticoa chocolate + 7.2g caster sugar + 5g Melissa
Placebo Comparator: Low Epicatechin/ Oat bran; 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; Single consumption of a 55g bar of white chocolate containing: 50g Lindor chocolate + 5g oat bran

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Prof. Dominique de Quervain, MD
• Investigators: Principal Investigator: Dominique DeQuervain, Prof. MD, University Basel Divison of Cognitive Neuroscience

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: MaRS-Basel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No