Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-03-29 @ 1:18 PM
Study NCT ID:
NCT02810769
Status:
COMPLETED
Last Update Posted:
2016-06-23
First Post:
2012-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Acute Effect of Two Berry Extracts on Cognition and Mood in Adults Aged 40 to 60
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-20', 'studyFirstSubmitDate': '2012-11-08', 'studyFirstSubmitQcDate': '2016-06-20', 'lastUpdatePostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': 'Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose'}, {'measure': 'Blood lactate', 'timeFrame': 'Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose'}, {'measure': 'Monoamine oxidase B inhibition', 'timeFrame': 'Change from baseline at 350 minutes post dose'}, {'measure': 'Cognitive Measures - Memory- Assessed using a computerised cognitive batter.', 'timeFrame': 'Change from baseline 60, 150, 240 and 360 minutes post dose'}, {'measure': 'Cognitive Measures - Attention- Assessed using a computerised cognitive batter.', 'timeFrame': 'Change from baseline 60, 150, 240 and 360 minutes post dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ageing']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nutrition-neuroscience.co.uk/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The first study of my PhD showed that acute supplementation of berry extracts can modulate cognitive behaviour in healthy adults. There is a growing body of evidence supporting an improvement in memory and learning performance in animal models following the ingestion of flavonoid rich fruits (Shukitt-Hale et al 2008;Spencer 2008; Spencer et al., 2008). However, study 2, showed no effect on any aspects of memory in healthy young adults after supplementation of the berry extracts. It is hypothesised that the lack of behavioural effects on memory of the berry juice in study 2 was because of the cohort used. These healthy adult participants were already performing near to their peak (Salthouse et al., 2009), and unlike study one, participants were not mentally fatigued enough to reveal subtle cognitive benefits.\n\nThe aims of the study are to examine if acute supplementation of two berry extracts in an older population can augment memory, attention and executive function. Secondly, the time course of these behavioural effects will be measured by multiple cognitive assessments throughout the day after consumption of the extracts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Non-smokers\n* Aged between 40 and 60 years\n\nExclusion Criteria:\n\n* History of neurological, vascular or psychiatric illness.\n* BMI greater than 35 kg/m2\n* Current diagnosis of depression and/or anxiety.\n* History or current diagnosis of drug/alcohol abuse.\n* Anaemia.\n* Any heart disorder.\n* Hypertension\n* Any respiratory disorder.\n* Diabetes.\n* Food intolerances/sensitivities.\n* Phenylketonuria.\n* Use tobacco products or have ceased in the last 6 months.\n* Currently taking, or have taken in the last 2 weeks, any prescribed, illicit or herbal drugs and food supplements.\n* Any known active infections.\n* HIV antibody positive.\n* Currently have, have ever had, or may be at risk of hepatitis.\n* Have suffered from jaundice within the last year.\n* Have haemophilia or any similar clotting disorder.\n* History of head trauma\n* History of migraines\n* History of learning difficulties\n* Any Issues with giving blood samples.'}, 'identificationModule': {'nctId': 'NCT02810769', 'briefTitle': 'The Acute Effect of Two Berry Extracts on Cognition and Mood in Adults Aged 40 to 60', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'The Acute Effect of Two Berry Extracts on Cognition and Mood in Adults Aged 40 to 60', 'orgStudyIdInfo': {'id': '28AI5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Sugar matched control containing no phytochemicals', 'interventionNames': ['Dietary Supplement: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Juiced berry drink', 'description': 'Cold pressed berry drink standardised to contain 500mg of berry polyphenols', 'interventionNames': ['Dietary Supplement: Berry drink']}, {'type': 'EXPERIMENTAL', 'label': 'Powdered berry drink', 'description': 'Berry drink made up from a powdered concentrate. each drink will be standardised to contain 500mg of polyphenols', 'interventionNames': ['Dietary Supplement: Powdered berry drink']}], 'interventions': [{'name': 'Berry drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cold pressed berry drink standardised to contain 500mg of berry polyphenols', 'armGroupLabels': ['Juiced berry drink']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Sugar matched control containing berry flavouring and no phytochemicals', 'armGroupLabels': ['Control']}, {'name': 'Powdered berry drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Berry drink made from a powder concentrate standardised to contain 500mg of polyphenols', 'armGroupLabels': ['Powdered berry drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE18ST', 'city': 'Newcastle upon Tyne', 'state': 'Newcastle Upon-Tyne', 'country': 'United Kingdom', 'facility': 'Brain, Performance and Nutrition Research Centre', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}]}, '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': 'Principal Investigator', 'investigatorFullName': 'Anthony Watson', 'investigatorAffiliation': 'Northumbria University'}}}}