Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 128
- Locations
- 2
- Primary Endpoint
- Verbal memory task
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Verbal memory task
Time Frame: 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
Time Frame: 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 Outcomes
- Saliva cortisol level(1 day after word/picture presentation Start /middle and end of day. Baseline cortisol 1-14 days later.)
- Visual Analogue Scale VAS confidence(1 day after word/picture presentation)
- Visual Analogue Scale VAS solicitude(1 day after word/picture presentation)
- Visual Analogue Scale VAS test anxiety(1 day after word/picture presentation)
- Visual Analogue Scale VAS interference(1 day after word/picture presentation)
- Working memory(1 day after word/picture presentation)
- Visual Analogue Scale VAS excitement(1 day after word/picture presentation)
Investigators
Prof. Dominique de Quervain, MD
Prof. Dominique de Quervain, MD
University of Basel