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OpenTrials
Completed

NCT Number: NCT03382067

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

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.

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Key information

Conditions

Test Anxiety

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Basel, Division of Cognitive Neuroscience

Basel, 4055, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High Epicatechin/ Melissa

Dietary Supplement

Single consumption of a 55g bar of dark chocolate containing: 42.8g Acticoa chocolate + 7.2g caster sugar + 5g Melissa

Low Epicatechin/ Oat bran

Other

Single consumption of a 55g bar of white chocolate containing: 50g Lindor chocolate + 5g oat bran

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Saliva cortisol level

    Time frame: 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

  2. Working memory

    Time frame: 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.

  3. Visual Analogue Scale VAS test anxiety

    Time frame: 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).

  4. Visual Analogue Scale VAS confidence

    Time frame: 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).

  5. Visual Analogue Scale VAS interference

    Time frame: 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).

  6. Visual Analogue Scale VAS solicitude

    Time frame: 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).

  7. Visual Analogue Scale VAS excitement

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Prof. Dominique de Quervain, MD

Other

Registry information

Acronym: MaRS-Basel

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2017
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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