Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-01 @ 6:30 PM
Study NCT ID:
NCT03382067
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2017-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2017-11-23', 'studyFirstSubmitQcDate': '2017-12-18', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pictorial memory task', 'timeFrame': '25 minutes and 24 h after presentation', 'description': '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.'}, {'measure': 'Verbal memory task', 'timeFrame': '25 minutes and 24 h after presentation', 'description': 'Six series of five semantically unrelated nouns will be presented.Total score is calculated by summing the number of correctly recalled words'}], 'secondaryOutcomes': [{'measure': 'Saliva cortisol level', 'timeFrame': '1 day after word/picture presentation Start /middle and end of day. Baseline cortisol 1-14 days later.', 'description': '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'}, {'measure': 'Working memory', 'timeFrame': '1 day after word/picture presentation', 'description': 'Participants will have to calculate as many arithmetical means of seven one-digit numbers possible within two minutes by mental calculation.'}, {'measure': 'Visual Analogue Scale VAS test anxiety', 'timeFrame': '1 day after word/picture presentation', 'description': '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).'}, {'measure': 'Visual Analogue Scale VAS confidence', 'timeFrame': '1 day after word/picture presentation', 'description': '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).'}, {'measure': 'Visual Analogue Scale VAS interference', 'timeFrame': '1 day after word/picture presentation', 'description': '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).'}, {'measure': 'Visual Analogue Scale VAS solicitude', 'timeFrame': '1 day after word/picture presentation', 'description': '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).'}, {'measure': 'Visual Analogue Scale VAS excitement', 'timeFrame': '1 day after word/picture presentation', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Test Anxiety']}, 'descriptionModule': {'briefSummary': '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.\n\nA 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.\n\nThe primary endpoints will be performance in a pictorial memory task and a verbal memory task .\n\nThe secondary endpoints will be performance in a working memory test, Saliva cortisol, Visual analog scales assessing, anxiety, confidence, interference, solicitude, and excitement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy by history\n* normotensive (BP between 90/60 mmHg and 140/90 mmHg)\n* BMI between 18 and \\< 30 kg/m2\n* male or female\n* aged between 18 and 30 years\n* native or fluent German-speaking\n* Prüfungsangstfragebogen (PAF) total or subscale interference score T value \\> 60\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to cocoa, Melissa, oat, vanillin, milk, soja, nuts\n* gluten intolerance\n* lactose intolerance\n* acute or chronic psychiatric disorder including drug or alcohol abuse\n* women who are pregnant or breast feeding\n* any clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease etc., infections)\n* known or suspected non-compliance\n* smoking (\\> 5 cigarettes per day)\n* participation in one of our previous studies using the same memory tests in the past 2 years\n* participation in a study with investigational drug within the 30 days preceding and during the present study\n* long-term medication within last 3 months (oral contraceptives are disregarded)'}, 'identificationModule': {'nctId': 'NCT03382067', 'acronym': 'MaRS-Basel', 'briefTitle': 'Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'University of Basel'}, 'officialTitle': 'Influence of Chocolate With Plant Additives on Episodic Memory in Healthy Subjects Experiencing Test Anxiety', 'orgStudyIdInfo': {'id': 'MaRS-Basel'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Epicatechin/ Melissa', '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', 'interventionNames': ['Dietary Supplement: High Epicatechin/ Melissa']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low Epicatechin/ Oat bran', 'description': 'Single consumption of a 55g bar of white chocolate containing: 50g Lindor ® chocolate + 5g oat bran containing \\< 0,0009 mg (-)-Epicatechin/100g', 'interventionNames': ['Other: Low Epicatechin/ Oat bran']}], 'interventions': [{'name': 'High Epicatechin/ Melissa', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single consumption of a 55g bar of dark chocolate containing: 42.8g Acticoa chocolate + 7.2g caster sugar + 5g Melissa', 'armGroupLabels': ['High Epicatechin/ Melissa']}, {'name': 'Low Epicatechin/ Oat bran', 'type': 'OTHER', 'description': 'Single consumption of a 55g bar of white chocolate containing: 50g Lindor chocolate + 5g oat bran', 'armGroupLabels': ['Low Epicatechin/ Oat bran']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4055', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University of Basel, Division of Cognitive Neuroscience', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Dominique DeQuervain, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Basel Divison of Cognitive Neuroscience'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dominique de Quervain, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dominique de Quervain, MD', 'investigatorFullName': 'Prof. Dominique de Quervain, MD', 'investigatorAffiliation': 'University of Basel'}}}}