Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-28 @ 12:09 PM
Study NCT ID:
NCT01376869
Status:
COMPLETED
Last Update Posted:
2012-06-25
First Post:
2011-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C548267', 'term': 'ALPL protein, human'}, {'id': 'D012822', 'term': 'Silicon Dioxide'}], 'ancestors': [{'id': 'D008903', 'term': 'Minerals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D017655', 'term': 'Silicon Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-22', 'studyFirstSubmitDate': '2011-06-16', 'studyFirstSubmitQcDate': '2011-06-16', 'lastUpdatePostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mood', 'timeFrame': 'across 3 hours', 'description': '* Mood as assessed by STAI, Bond-Lader mood scales, POMS, DEQ and stress/euphoria/sedation visual analogue scales (VAS).\n* The shift in mood (STAI, Bond-Lader, POMS, DEQ, Stress/Euphoria/Sedation VAS) inculcated by completion of cognitive tasks.\n* Heart rate and blood pressure.\n* The modulation of blood pressure and heart rate inculcated by completion of cognitive tasks.'}], 'secondaryOutcomes': [{'measure': 'Satiety', 'timeFrame': 'across 3 hours', 'description': '* Satiety as assessed by VAS (hungry/full/desire to eat/food intake).\n* The modulation of satiety (VAS) inculcated by completion of the cognitive tasks.'}, {'measure': 'Bioavailability of Hops', 'timeFrame': 'across 3 hours', 'description': '• Plasma hops levels are to be examined to assess bioavailability.'}, {'measure': 'Cognition', 'timeFrame': 'across 3 hours', 'description': '* Performance on working memory tasks (2-back and logical reasoning).\n* Performance on serial subtraction element of a dual task.\n* Performance on word and picture recognition tasks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hops', 'Mood', 'Cognitive Function', 'Bioavailability', 'Satiety', 'Blood Pressure', 'Heart rate'], 'conditions': ['Mood Modulation', 'Modulation of Cognition']}, 'descriptionModule': {'briefSummary': 'Hops have been used for many years for their supposed sedative and anxiety reducing properties and can be found in many natural remedies for stress, anxiety and sleeping that are already available to buy.\n\nHowever, human trials investigating the effects of hops have so far been limited to the effects of the combination of hops and valerian in relation to sleep. Such studies have identified that a valerian-hops mixture can result in improved sleep but Valerian alone has no effect.\n\nThe current study aims to investigate the effect of hops alone in healthy human participants aged 18-35 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/female,\n* Healthy\n* Age 18-35 years old\n* Non smoker\n* Proficient in English\n* Not taking any herbal or prescription medications\n* Not pregnant seeking to become pregnant or breastfeeding\n\nExclusion Criteria:\n\n* Allergy or hypersensitivity to any of the ingredients contained in the investigational product or any other foodstuff.\n* Vegetarian (as the capsules contain gelatine).\n* Have a history of neurological, vascular or psychiatric illness (including depressive illness and anxiety).\n* Have a current/ history of drug or alcohol abuse.\n* Currently take medication (excluding the contraceptive pill).\n* High Blood Pressure (\\>140/90)\n* BMI outside of the range 18- 34.9'}, 'identificationModule': {'nctId': 'NCT01376869', 'briefTitle': 'Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants', 'orgStudyIdInfo': {'id': '21AO1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '102mg extract 1 hops', 'description': 'Equivalent to 0.5g dry weight', 'interventionNames': ['Dietary Supplement: Hops Extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': '410mg extract 1 hops', 'description': 'Equivalent to 2g dry weight', 'interventionNames': ['Dietary Supplement: Hops Extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': '79mg extract 2 hops', 'description': 'Equivalent to 0.5g dry weight', 'interventionNames': ['Dietary Supplement: Hops Extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': '316mg extract 2 hops', 'description': 'Equivalent to 2g dry weight', 'interventionNames': ['Dietary Supplement: Hops Extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo (silica)']}], 'interventions': [{'name': 'Hops Extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'All 150 participants will complete 1 study visit; receiving either of the 4 hops doses or placebo (silica). Computer generated random numbers will be used to allocate treatments to participant identification numbers. Treatment will be administered in capsule form and in a double blind manner.', 'armGroupLabels': ['102mg extract 1 hops', '316mg extract 2 hops', '410mg extract 1 hops', '79mg extract 2 hops']}, {'name': 'Placebo (silica)', 'type': 'OTHER', 'description': 'All 150 participants will complete 1 study visit; receiving either of the 4 hops doses or placebo (silica). Computer generated random numbers were used to allocate treatments to participant identification numbers. Treatment will be administered in capsule form and in a double blind manner.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE1 8ST', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Northumbria University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Crystal Haskell', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Northumbria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The New Zealand Institute of Plant and Food Research Ltd.', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Crystal Haskell', 'investigatorAffiliation': 'Northumbria University'}}}}