Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-07 @ 12:08 PM
Study NCT ID:
NCT03878368
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2019-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Broccoli In Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C016766', 'term': 'sulforaphane'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2019-03-14', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC (Western Ontario and McMaster Universities Arthritis Index)', 'timeFrame': 'Baseline and 12 weeks.', 'description': 'Change in the WOMAC (Western Ontario and McMaster Universities Arthritis Index) pain subscale.'}], 'secondaryOutcomes': [{'measure': 'WOMAC (Western Ontario and McMaster Universities Arthritis Index): Pain', 'timeFrame': '6 weeks', 'description': 'Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright'}, {'measure': 'WOMAC (Western Ontario and McMaster Universities Arthritis Index): Physical Function', 'timeFrame': '6 & 12 weeks', 'description': 'Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties'}, {'measure': 'WOMAC (Western Ontario and McMaster Universities Arthritis Index): Stiffness', 'timeFrame': '6 & 12 weeks', 'description': 'Stiffness (2 items): after first waking and later in the day'}, {'measure': '11 Point Pain Numerical Rating Scale (NRS): Average overall knee pain severity in the index knee over the past 1 week', 'timeFrame': '6&12 weeks', 'description': "Minimum score '0' to maximum score '10' Lower numerical value is the better outcome"}, {'measure': '11 Point Pain Numerical Rating Scale (NRS): Worst knee pain severity in the index knee over the past 1 week', 'timeFrame': '6&12 weeks', 'description': "Minimum score '0' to maximum score '10' Lower numerical value is the better outcome"}, {'measure': '11 Point Pain Numerical Rating Scale (NRS): Global disease activity over the past 1 week', 'timeFrame': '6&12 weeks', 'description': "Minimum score '0' to maximum score '10' Lower numerical value is the better outcome"}, {'measure': '11 point pain Numerical Rating Scale (NRS): Satisfaction with index knee function over the past 1 week', 'timeFrame': '6&12 weeks', 'description': "Minimum score '0' to maximum score '10' Lower numerical value is the better outcome"}, {'measure': '11 point pain Numerical Rating Scale (NRS): Average pain in other joints over the past 1 week', 'timeFrame': '6&12 weeks', 'description': "Minimum score '0' to maximum score '10' Lower numerical value is the better outcome"}, {'measure': 'Pain in other joints', 'timeFrame': '6&12 weeks', 'description': 'Joint manikin'}, {'measure': 'Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)', 'timeFrame': '6&12 weeks', 'description': 'Self-Assessment'}, {'measure': 'Rescue analgesics/NSAIDs', 'timeFrame': '6&12 weeks', 'description': 'Use of rescue analgesics/NSAIDs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sulforaphane'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'To determine whether dietary sulforaphane (SFN), naturally available from eating broccoli, improves pain in people with knee osteoarthritis (OA), the trial will compare broccoli soup (rich in SFN) with a soup, which does not contain broccoli (control), but looks and tastes the same. Sixty-four participants with moderate osteoarthritis, chosen at random, will either have the broccoli or the control soup. The participants will eat the soup once-a-day, for 4 days-a-week for 3 months.', 'detailedDescription': 'This is the first clinical trial to test the benefits of eating broccoli on pain and physical function in knee osteoarthritis (OA).\n\nMany fruits and vegetables in the normal human diet contain substances that may improve human health or disease. There is increasingly strong laboratory data that indicate that exposure to these substances at the levels found in the diet influence the way in which osteoarthritis develops. Sulforaphane (SFN) is a naturally occurring substance found in vegetables such as broccoli and is known to have helpful effects on cartilage cells. Sulforaphane derived from broccoli, has a potential role in limiting pain and cartilage destruction in OA.\n\nThe investigators have shown that:\n\n* SFN can stop inflammation in mice with OA\n* SFN blocks the production of the enzymes which break down cartilage in OA, both in cell cultures and in pieces of cartilage\n* SFN enters the joint in participants provided with a high broccoli diet ahead of a knee replacement and alters the types of proteins present in the joint fluid\n\nThe investigators aim to discover for the first time in man, whether a broccoli-rich diet will improve pain and physical function in participants with knee osteoarthritis. The study will provide the much-needed preliminary data that will allow the investigators to design a clinical trial to prove that broccoli can be recommended as a helpful food for people with OA.\n\nThe trial will compare broccoli soup (rich in SFN) with a soup, which does not contain broccoli (control), but looks and tastes the same. Sixty-four participants with moderate osteoarthritis will either have the broccoli or the control soup, chosen at random. The participants will eat the soup once-a-day, for 4 days-a-week for 3 months. The investigators will measure pain and physical function at the start of the trial, at 6 weeks and at 12 weeks and look at the changes in these. The investigators will also take blood samples and collect urine to measure SFN levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Current knee pain, defined as pain in either knee, in the (one) month before Visit 1, for which the patient gives a severity score of at least 4 on a 0-10 numeric rating scale (NRS).\n2. The target knee should fulfil the criteria of the American College of Rheumatology (ACR) for knee osteoarthritis defined as knee pain for most days of the prior month and at least one of the following three factors: age over 50 years; morning stiffness of less than 30 minutes; knee crepitus on motion.\n3. Kellgren Lawrence grade 2-3\n4. Stable analgesic usage (if using) for 4 weeks prior to trial entry and throughout the trial duration\n5. Able to adhere to the study visit schedule and other protocol requirements (willing to consume soup intervention).\n6. Willing to provide 24 hour urine collection samples (x3)\n7. Capable of giving informed consent and the consent must be obtained prior to any screening procedures.\n\nExclusion Criteria:\n\n1. The presence of any inflammatory arthritis (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondylarthropathy) or fibromyalgia or metabolic bone disease.\n2. Any clinically significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study.\n3. Known or suspected intolerance or hypersensitivity to the investigational product (broccoli) or standardised meal (see section 9.2), closely related compounds, or any of the stated ingredients.\n4. Use of an investigational product within 30 days prior to 'run in' period or active enrolment in another drug or vaccine clinical study.\n5. Significant knee injury or any knee surgery within the 6 months preceding enrolment in the study.\n6. A history of partial or complete joint replacement surgery in the signal knee at any time, listed for knee surgery, or anticipating knee surgery during the study period.\n7. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period\n8. Nutritional deficiency\n9. Use of anticoagulant medication (see notes for inclusion exclusion criteria)\n10. Use of intra-articular hyaluronic acid in the signal knee within the 3 months preceding enrolment in the study.\n11. Use of intra-articular, intra-muscular or oral corticosteroids in the 2 months preceding enrolment.\n12. Commencement of non-pharmacological interventions within two months preceding enrolment.\n13. Persons less than 50 years\n14. Pregnant/lactating women"}, 'identificationModule': {'nctId': 'NCT03878368', 'acronym': 'BRIO', 'briefTitle': 'Broccoli In Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of East Anglia'}, 'officialTitle': 'A Dietary Intervention Trial to Examine the Effect of Broccoli Bioactives (Specifically Sulforaphane) on Osteoarthritis (OA)', 'orgStudyIdInfo': {'id': 'BRIO Protocol V4.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '32 participants with moderate osteoarthritis will eat soup with the active ingredient once-a-day for 4 days-a-week for 3 months.', 'interventionNames': ['Dietary Supplement: Sulforaphane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': '32 participants with moderate osteoarthritis will eat soup without the active ingredient once-a-day for 4 days-a-week for 3 months.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Sulforaphane', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intervention soup with dietary sulforaphane', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Control soup without dietary sulforaphane', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NR4 7UY', 'city': 'Norwich', 'state': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Norfolk & Norwich University Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'LS7 4SA', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'Chapel Allerton Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Alexander MacGregor, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of East Anglia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of East Anglia', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Leeds', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}