Test AnxietyMaRS-BaselNCT03382067
Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety
A study testing High Epicatechin/ Melissa and Low Epicatechin/ Oat bran in people with Test Anxiety, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Test Anxiety
- What is being tested?
- High Epicatechin/ Melissa and Low Epicatechin/ Oat bran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Dec 2017to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Division of Cognitive Neuroscience
Basel, 4055
About this study
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.
Read more
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
- Being tested
- High Epicatechin/ Melissa, Low Epicatechin/ Oat bran
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Epicatechin/ MelissaDietary supplement
Single consumption of a 55g bar of dark chocolate containing: 42.8g Acticoa chocolate + 7.2g caster sugar + 5g Melissa
Low Epicatechin/ Oat branOther
Single consumption of a 55g bar of white chocolate containing: 50g Lindor chocolate + 5g oat bran
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Low Epicatechin/ Oat bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 25 minutes and 24 h after presentation
Secondary outcomes (7)
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
Measured: 1 day after word/picture presentation Start /middle and end of day. Baseline cortisol 1-14 days later.
Working memory
Participants will have to calculate as many arithmetical means of seven one-digit numbers possible within two minutes by mental calculation.
Measured: 1 day after word/picture presentation
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).
Measured: 1 day after word/picture presentation
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).
Measured: 1 day after word/picture presentation
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).
Measured: 1 day after word/picture presentation
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).
Measured: 1 day after word/picture presentation
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).
Measured: 1 day after word/picture presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start4 Dec 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Test AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dominique de Quervain, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dominique de Quervain, MD, University of Basel
- Investigators
- Dominique DeQuervain, Prof. MD, Principal investigator, University Basel Divison of Cognitive Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382067
- Sponsor's protocol ID
- MaRS-Basel
- Acronym
- MaRS-Basel
- Status last verified
- Sep 2018
- First submitted
- 23 Nov 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety
- ClinicalTrials.gov ID
- NCT03382067
- Acronym / sponsor ID
- MaRS-Basel / MaRS-Basel
- Conditions
- Test Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Prof. Dominique de Quervain, MDUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Epicatechin/ Melissa | Active comparator | Dietary Supplement: High Epicatechin/ MelissaSingle 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 |
| Low Epicatechin/ Oat bran | Placebo comparator | Other: Low Epicatechin/ Oat branSingle consumption of a 55g bar of white chocolate containing: 50g Lindor ® chocolate + 5g oat bran containing < 0,0009 mg (-)-Epicatechin/100g |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Epicatechin/ MelissaSingle consumption of a 55g bar of dark chocolate containing: 42.8g Acticoa chocolate + 7.2g caster sugar + 5g Melissa | Dietary supplement | High Epicatechin/ Melissa |
| Low Epicatechin/ Oat branSingle consumption of a 55g bar of white chocolate containing: 50g Lindor chocolate + 5g oat bran | Other | Low Epicatechin/ Oat bran |
Primary outcome
Pictorial memory task
Time frame: 25 minutes and 24 h after presentation
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.
Verbal memory task
Time frame: 25 minutes and 24 h after presentation
Six series of five semantically unrelated nouns will be presented.Total score is calculated by summing the number of correctly recalled words
7 secondary outcomes
Saliva cortisol level
Time frame: 1 day after word/picture presentation Start /middle and end of day. Baseline cortisol 1-14 days later.
Working memory
Time frame: 1 day after word/picture presentation
Visual Analogue Scale VAS test anxiety
Time frame: 1 day after word/picture presentation
Visual Analogue Scale VAS confidence
Time frame: 1 day after word/picture presentation
Visual Analogue Scale VAS interference
Time frame: 1 day after word/picture presentation
Visual Analogue Scale VAS solicitude
Time frame: 1 day after word/picture presentation
Visual Analogue Scale VAS excitement
Time frame: 1 day after word/picture presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique DeQuervain, Prof. MD principal investigator
University Basel Divison of Cognitive Neuroscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Epicatechin/ Melissa and Low Epicatechin/ Oat bran in people with Test Anxiety, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pictorial memory task (time frame: 25 minutes and 24 h after presentation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.