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

NCT03382067 | Completed

• 1 other identifier: MaRS-Basel
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Saliva cortisol level

  1 day after word/picture presentation Start /middle and end of day. Baseline cortisol 1-14 days later.

• Working memory

  1 day after word/picture presentation

• Visual Analogue Scale VAS test anxiety

  1 day after word/picture presentation

• Visual Analogue Scale VAS confidence

  1 day after word/picture presentation

• Visual Analogue Scale VAS interference

  1 day after word/picture presentation

Study Arms (2)

High Epicatechin/ Melissa

ACTIVE COMPARATOR

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

Dietary Supplement: High Epicatechin/ Melissa

Low Epicatechin/ Oat bran

PLACEBO COMPARATOR

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

Other: Low Epicatechin/ Oat bran

Interventions

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

High Epicatechin/ Melissa

Low Epicatechin/ Oat bran OTHER

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

Low Epicatechin/ Oat bran

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Prof. Dominique de Quervain, MD: lead

Study Sites (1)

University of Basel, Division of Cognitive Neuroscience

Basel, 4055, Switzerland

Location

Study Officials

• Dominique DeQuervain, Prof. MD

  University Basel Divison of Cognitive Neuroscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dominique de Quervain, MD

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: December 22, 2017
• Study Start: December 4, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)