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

N/ACompletedNCT03382067

Prof. Dominique de Quervain, MD128 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

128

Conditions

Test Anxiety

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 25 minutes and 24 h after presentation

Secondary Outcomes

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

Time frame: 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.