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

Test Anxiety Clinical Trial

— MaRS-Basel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382067
• Other study ID #: MaRS-Basel
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Test Anxiety

Intervention

Dietary Supplement:
• High Epicatechin/ Melissa
Single consumption of a 55g bar of dark chocolate containing: 42.8g Acticoa chocolate + 7.2g caster sugar + 5g Melissa

Other:
• Low Epicatechin/ Oat bran
Single consumption of a 55g bar of white chocolate containing: 50g Lindor chocolate + 5g oat bran

Locations

Country	Name	City	State
Switzerland	University of Basel, Division of Cognitive Neuroscience	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dominique de Quervain, MD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	25 minutes and 24 h after presentation
Primary	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	25 minutes and 24 h after presentation
Secondary	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	1 day after word/picture presentation Start /middle and end of day. Baseline cortisol 1-14 days later.
Secondary	Working memory	Participants will have to calculate as many arithmetical means of seven one-digit numbers possible within two minutes by mental calculation.	1 day after word/picture presentation
Secondary	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).	1 day after word/picture presentation
Secondary	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).	1 day after word/picture presentation
Secondary	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).	1 day after word/picture presentation
Secondary	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).	1 day after word/picture presentation
Secondary	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).	1 day after word/picture presentation