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Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety (MaRS-Basel)

Primary Purpose

Test Anxiety

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
High Epicatechin/ Melissa
Low Epicatechin/ Oat bran
Sponsored by
Prof. Dominique de Quervain, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Test Anxiety

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Basel, Division of Cognitive Neuroscience

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

High Epicatechin/ Melissa

Low Epicatechin/ Oat bran

Arm Description

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

Single consumption of a 55g bar of white chocolate containing: 50g Lindor ® chocolate + 5g oat bran containing < 0,0009 mg (-)-Epicatechin/100g

Outcomes

Primary Outcome Measures

Pictorial memory task
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.
Verbal memory task
Six series of five semantically unrelated nouns will be presented.Total score is calculated by summing the number of correctly recalled words

Secondary Outcome Measures

Saliva cortisol level
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
Working memory
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 test anxiety
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 confidence
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
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
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 excitement
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).

Full Information

First Posted
November 23, 2017
Last Updated
September 4, 2018
Sponsor
Prof. Dominique de Quervain, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03382067
Brief Title
Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety
Acronym
MaRS-Basel
Official Title
Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dominique de Quervain, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Test Anxiety

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Epicatechin/ Melissa
Arm Type
Active Comparator
Arm Description
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
Arm Title
Low Epicatechin/ Oat bran
Arm Type
Placebo Comparator
Arm Description
Single consumption of a 55g bar of white chocolate containing: 50g Lindor ® chocolate + 5g oat bran containing < 0,0009 mg (-)-Epicatechin/100g
Intervention Type
Dietary Supplement
Intervention Name(s)
High Epicatechin/ Melissa
Intervention Description
Single consumption of a 55g bar of dark chocolate containing: 42.8g Acticoa chocolate + 7.2g caster sugar + 5g Melissa
Intervention Type
Other
Intervention Name(s)
Low Epicatechin/ Oat bran
Intervention Description
Single consumption of a 55g bar of white chocolate containing: 50g Lindor chocolate + 5g oat bran
Primary Outcome Measure Information:
Title
Pictorial memory task
Description
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.
Time Frame
25 minutes and 24 h after presentation
Title
Verbal memory task
Description
Six series of five semantically unrelated nouns will be presented.Total score is calculated by summing the number of correctly recalled words
Time Frame
25 minutes and 24 h after presentation
Secondary Outcome Measure Information:
Title
Saliva cortisol level
Description
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
Time Frame
1 day after word/picture presentation Start /middle and end of day. Baseline cortisol 1-14 days later.
Title
Working memory
Description
Participants will have to calculate as many arithmetical means of seven one-digit numbers possible within two minutes by mental calculation.
Time Frame
1 day after word/picture presentation
Title
Visual Analogue Scale VAS test anxiety
Description
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).
Time Frame
1 day after word/picture presentation
Title
Visual Analogue Scale VAS confidence
Description
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).
Time Frame
1 day after word/picture presentation
Title
Visual Analogue Scale VAS interference
Description
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).
Time Frame
1 day after word/picture presentation
Title
Visual Analogue Scale VAS solicitude
Description
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).
Time Frame
1 day after word/picture presentation
Title
Visual Analogue Scale VAS excitement
Description
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).
Time Frame
1 day after word/picture presentation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique DeQuervain, Prof. MD
Organizational Affiliation
University Basel Divison of Cognitive Neuroscience
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Basel, Division of Cognitive Neuroscience
City
Basel
ZIP/Postal Code
4055
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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