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

NCT ID: NCT03382067

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2018-08-31

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.

Conditions

Test Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

High Epicatechin/ Melissa

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Low Epicatechin/ Oat bran

Intervention Type: OTHER

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

Interventions

High Epicatechin/ Melissa

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

Intervention Type: DIETARY_SUPPLEMENT

Low Epicatechin/ Oat bran

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prof. Dominique de Quervain, MD

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dominique de Quervain, MD

Prof. Dominique de Quervain, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dominique DeQuervain, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University Basel Divison of Cognitive Neuroscience

Locations

University of Basel, Division of Cognitive Neuroscience

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

MaRS-Basel

Identifier Type: -

Identifier Source: org_study_id