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

Not Applicable

Completed

• Conditions: Test Anxiety

• Registration Number: NCT03382067
• Lead Sponsor: Prof. Dominique de Quervain, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-23
• Study Start: 2017-12-04
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-22
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Verbal memory task	25 minutes and 24 h after presentation	Six series of five semantically unrelated nouns will be presented.Total score is calculated by summing the number of correctly recalled words
Pictorial memory task	25 minutes and 24 h after presentation	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.

Secondary Outcome Measures

Name	Time	Method
Saliva cortisol level	1 day after word/picture presentation Start /middle and end of day. Baseline cortisol 1-14 days later.	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
Visual Analogue Scale VAS confidence	1 day after word/picture presentation	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).
Visual Analogue Scale VAS solicitude	1 day after word/picture presentation	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).
Visual Analogue Scale VAS test anxiety	1 day after word/picture presentation	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).
Visual Analogue Scale VAS interference	1 day after word/picture presentation	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).
Working memory	1 day after word/picture presentation	Participants will have to calculate as many arithmetical means of seven one-digit numbers possible within two minutes by mental calculation.
Visual Analogue Scale VAS excitement	1 day after word/picture presentation	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).

Trial Locations

Locations (1)

University of Basel, Division of Cognitive Neuroscience; 🇨🇭 Basel, Switzerland