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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03382067
Acronym
MaRS-Basel
Enrollment
128
Registered
2017-12-22
Start date
2017-12-04
Completion date
2018-08-31
Last updated
2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Test Anxiety

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.

Interventions

DIETARY_SUPPLEMENTHigh Epicatechin/ Melissa

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

OTHERLow Epicatechin/ Oat bran

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

Sponsors

Prof. Dominique de Quervain, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Pictorial memory task25 minutes and 24 h after presentationParticipants 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 task25 minutes and 24 h after presentationSix series of five semantically unrelated nouns will be presented.Total score is calculated by summing the number of correctly recalled words

Secondary

MeasureTime frameDescription
Visual Analogue Scale VAS test anxiety1 day after word/picture presentationwill 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 confidence1 day after word/picture presentationwill 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).
Saliva cortisol level1 day after word/picture presentation Start /middle and end of day. Baseline cortisol 1-14 days later.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
Visual Analogue Scale VAS solicitude1 day after word/picture presentationwill 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 excitement1 day after word/picture presentationwill 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 interference1 day after word/picture presentationwill 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).
Working memory1 day after word/picture presentationParticipants will have to calculate as many arithmetical means of seven one-digit numbers possible within two minutes by mental calculation.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026