Clinical trial NCT03382067: Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety
Official title: Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Test Anxiety
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Pictorial memory task
timeFrame: 25 minutes and 24 h after presentation
measure: Verbal memory task
timeFrame: 25 minutes and 24 h after presentation
Secondary outcomes:
measure: Saliva cortisol level
timeFrame: 1 day after word/picture presentation Start /middle and end of day. Baseline cortisol 1-14 days later.
measure: Working memory
timeFrame: 1 day after word/picture presentation
measure: Visual Analogue Scale VAS test anxiety
timeFrame: 1 day after word/picture presentation
measure: Visual Analogue Scale VAS confidence
timeFrame: 1 day after word/picture presentation
measure: Visual Analogue Scale VAS interference
timeFrame: 1 day after word/picture presentation
measure: Visual Analogue Scale VAS solicitude
timeFrame: 1 day after word/picture presentation
measure: Visual Analogue Scale VAS excitement
timeFrame: 1 day after word/picture presentation
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Division of Cognitive Neuroscience
Study officials:
affiliation: University Basel Divison of Cognitive Neuroscience
name: Dominique DeQuervain, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: