Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety
- Conditions
- Test Anxiety
- Interventions
- Dietary Supplement: High Epicatechin/ MelissaOther: Low Epicatechin/ Oat bran
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- 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
- 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
- Arm && Interventions
Group Intervention Description High Epicatechin/ Melissa 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 Low Epicatechin/ Oat bran 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
- 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