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Broccoli In Osteoarthritis (BRIO)

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ClinicalTrials.gov Identifier: NCT03878368
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : May 7, 2021
Sponsor:
Collaborator:
University of Leeds
Information provided by (Responsible Party):
University of East Anglia

Tracking Information
First Submitted Date  ICMJE March 14, 2019
First Posted Date  ICMJE March 18, 2019
Last Update Posted Date May 7, 2021
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
WOMAC (Western Ontario and McMaster Universities Arthritis Index) [ Time Frame: Baseline and 12 weeks. ]
Change in the WOMAC (Western Ontario and McMaster Universities Arthritis Index) pain subscale.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • WOMAC (Western Ontario and McMaster Universities Arthritis Index): Pain [ Time Frame: 6 weeks ]
    Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright
  • WOMAC (Western Ontario and McMaster Universities Arthritis Index): Physical Function [ Time Frame: 6 & 12 weeks ]
    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
  • WOMAC (Western Ontario and McMaster Universities Arthritis Index): Stiffness [ Time Frame: 6 & 12 weeks ]
    Stiffness (2 items): after first waking and later in the day
  • 11 Point Pain Numerical Rating Scale (NRS): Average overall knee pain severity in the index knee over the past 1 week [ Time Frame: 6&12 weeks ]
    Minimum score '0' to maximum score '10' Lower numerical value is the better outcome
  • 11 Point Pain Numerical Rating Scale (NRS): Worst knee pain severity in the index knee over the past 1 week [ Time Frame: 6&12 weeks ]
    Minimum score '0' to maximum score '10' Lower numerical value is the better outcome
  • 11 Point Pain Numerical Rating Scale (NRS): Global disease activity over the past 1 week [ Time Frame: 6&12 weeks ]
    Minimum score '0' to maximum score '10' Lower numerical value is the better outcome
  • 11 point pain Numerical Rating Scale (NRS): Satisfaction with index knee function over the past 1 week [ Time Frame: 6&12 weeks ]
    Minimum score '0' to maximum score '10' Lower numerical value is the better outcome
  • 11 point pain Numerical Rating Scale (NRS): Average pain in other joints over the past 1 week [ Time Frame: 6&12 weeks ]
    Minimum score '0' to maximum score '10' Lower numerical value is the better outcome
  • Pain in other joints [ Time Frame: 6&12 weeks ]
    Joint manikin
  • Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) [ Time Frame: 6&12 weeks ]
    Self-Assessment
  • Rescue analgesics/NSAIDs [ Time Frame: 6&12 weeks ]
    Use of rescue analgesics/NSAIDs
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • WOMAC [ Time Frame: 6 weeks ]
    Pain
  • WOMAC [ Time Frame: 6&12 weeks ]
    Physical function
  • WOMAC [ Time Frame: 6 & 12 weeks ]
    Stiffness
  • 11 point pain scale NRS (Numerical Rating Scale) [ Time Frame: 6&12 weeks ]
    11 point pain scale
  • NRS (Numerical Rating Scale) [ Time Frame: 6&12 weeks ]
    Average overall knee pain severity in the index knee over the past 1 week
  • 11 point pain NRS (Numerical Rating Scale) [ Time Frame: 6&12 weeks ]
    Worst knee pain severity in the index knee over the past 1 week
  • 11 point pain NRS (Numerical Rating Scale) [ Time Frame: 6&12 weeks ]
    Global disease activity over the past 1 week
  • 11 point pain NRS (Numerical Rating Scale) [ Time Frame: 6&12 weeks ]
    Satisfaction with index knee function over the past 1 week
  • 11 point pain NRS (Numerical Rating Scale) [ Time Frame: 6&12 weeks ]
    Average pain in other joints over the past 1 week
  • Pain in other joints [ Time Frame: 6&12 weeks ]
    Joint manikin
  • Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) [ Time Frame: 6&12 weeks ]
    Self-Assessment
  • Rescue analgesics/NSAIDs [ Time Frame: 6&12 weeks ]
    Use of rescue analgesics/NSAIDs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Broccoli In Osteoarthritis
Official Title  ICMJE A Dietary Intervention Trial to Examine the Effect of Broccoli Bioactives (Specifically Sulforaphane) on Osteoarthritis (OA)
Brief Summary 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.
Detailed Description

This is the first clinical trial to test the benefits of eating broccoli on pain and physical function in knee osteoarthritis (OA).

Many 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.

The investigators have shown that:

  • SFN can stop inflammation in mice with OA
  • SFN blocks the production of the enzymes which break down cartilage in OA, both in cell cultures and in pieces of cartilage
  • 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

The 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.

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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Dietary Supplement: Sulforaphane
    Intervention soup with dietary sulforaphane
  • Dietary Supplement: Placebo
    Control soup without dietary sulforaphane
Study Arms  ICMJE
  • Experimental: Intervention
    32 participants with moderate osteoarthritis will eat soup with the active ingredient once-a-day for 4 days-a-week for 3 months.
    Intervention: Dietary Supplement: Sulforaphane
  • Active Comparator: Control
    32 participants with moderate osteoarthritis will eat soup without the active ingredient once-a-day for 4 days-a-week for 3 months.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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).
  2. 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.
  3. Kellgren Lawrence grade 2-3
  4. Stable analgesic usage (if using) for 4 weeks prior to trial entry and throughout the trial duration
  5. Able to adhere to the study visit schedule and other protocol requirements (willing to consume soup intervention).
  6. Willing to provide 24 hour urine collection samples (x3)
  7. Capable of giving informed consent and the consent must be obtained prior to any screening procedures.

Exclusion Criteria:

  1. The presence of any inflammatory arthritis (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondylarthropathy) or fibromyalgia or metabolic bone disease.
  2. 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.
  3. 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.
  4. Use of an investigational product within 30 days prior to 'run in' period or active enrolment in another drug or vaccine clinical study.
  5. Significant knee injury or any knee surgery within the 6 months preceding enrolment in the study.
  6. 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.
  7. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period
  8. Nutritional deficiency
  9. Use of anticoagulant medication (see notes for inclusion exclusion criteria)
  10. Use of intra-articular hyaluronic acid in the signal knee within the 3 months preceding enrolment in the study.
  11. Use of intra-articular, intra-muscular or oral corticosteroids in the 2 months preceding enrolment.
  12. Commencement of non-pharmacological interventions within two months preceding enrolment.
  13. Persons less than 50 years
  14. Pregnant/lactating women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rose Davidson, PhD +44(0)1603591789 R.Davidson@uea.ac.uk
Contact: Ian Clark, PhD +44 (0)1603 59 2760 I.Clark@uea.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03878368
Other Study ID Numbers  ICMJE BRIO Protocol V4.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of East Anglia
Study Sponsor  ICMJE University of East Anglia
Collaborators  ICMJE University of Leeds
Investigators  ICMJE
Study Director: Alexander MacGregor, PhD University of East Anglia
PRS Account University of East Anglia
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP