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

Prof. Dominique de Quervain, MD

Status: Completed

Conditions: Test Anxiety

Treatments: Other: Low Epicatechin/ Oat bran; Dietary Supplement: High Epicatechin/ Melissa

Study type: Interventional

Funder types: Other

Identifiers

NCT03382067

MaRS-Basel

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups, including a placebo group

High Epicatechin/ Melissa

Active Comparator group

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

Treatment:

Dietary Supplement: High Epicatechin/ Melissa

Low Epicatechin/ Oat bran

Placebo Comparator group

Description:

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

Treatment:

Other: Low Epicatechin/ Oat bran