OsteoarthritisBRIONCT03878368
Broccoli In Osteoarthritis
A study testing Sulforaphane in people with Osteoarthritis, run by University of East Anglia at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Sulforaphane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 May 2019to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- 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.
- Kellgren Lawrence grade 2-3
- Stable analgesic usage (if using) for 4 weeks prior to trial entry and throughout the trial duration
- Able to adhere to the study visit schedule and other protocol requirements (willing to consume soup intervention).
- Willing to provide 24 hour urine collection samples (x3)
- Capable of giving informed consent and the consent must be obtained prior to any screening procedures.
Who cannot join
- The presence of any inflammatory arthritis (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondylarthropathy) or fibromyalgia or metabolic bone disease.
- 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.
- 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.
- Use of an investigational product within 30 days prior to 'run in' period or active enrolment in another drug or vaccine clinical study.
- Significant knee injury or any knee surgery within the 6 months preceding enrolment in the study.
- 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.
Show all 14Show fewer
- Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period
- Nutritional deficiency
- Use of anticoagulant medication (see notes for inclusion exclusion criteria)
- Use of intra-articular hyaluronic acid in the signal knee within the 3 months preceding enrolment in the study.
- Use of intra-articular, intra-muscular or oral corticosteroids in the 2 months preceding enrolment.
- Commencement of non-pharmacological interventions within two months preceding enrolment.
- Persons less than 50 years
- Pregnant/lactating women
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Chapel Allerton Hospital
Leeds, West Yorkshire, LS7 4SA
Norfolk & Norwich University Hospital
Norwich, Norfolk, NR4 7UY
About this study
Official title: A Dietary Intervention Trial to Examine the Effect of Broccoli Bioactives (Specifically Sulforaphane) on Osteoarthritis (OA)
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Sulforaphane, Placebo
- Keywords
- Sulforaphane
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulforaphaneDietary supplement
Intervention soup with dietary sulforaphane
PlaceboDietary supplement
Control soup without dietary sulforaphane
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 32 participants with moderate osteoarthritis will eat soup with the active ingredient once-a-day for 4 days-a-week for 3 months. Receives: Dietary Supplement: Sulforaphane |
| Control | Active comparator | 32 participants with moderate osteoarthritis will eat soup without the active ingredient once-a-day for 4 days-a-week for 3 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC (Western Ontario and McMaster Universities Arthritis Index)
Change in the WOMAC (Western Ontario and McMaster Universities Arthritis Index) pain subscale.
Measured: Baseline and 12 weeks.
Secondary outcomes (11)
WOMAC (Western Ontario and McMaster Universities Arthritis Index): Pain
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright
Measured: 6 weeks
WOMAC (Western Ontario and McMaster Universities Arthritis Index): Physical Function
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
Measured: 6 & 12 weeks
WOMAC (Western Ontario and McMaster Universities Arthritis Index): Stiffness
Stiffness (2 items): after first waking and later in the day
Measured: 6 & 12 weeks
11 Point Pain Numerical Rating Scale (NRS): Average overall knee pain severity in the index knee over the past 1 week
Minimum score '0' to maximum score '10' Lower numerical value is the better outcome
Measured: 6&12 weeks
11 Point Pain Numerical Rating Scale (NRS): Worst knee pain severity in the index knee over the past 1 week
Minimum score '0' to maximum score '10' Lower numerical value is the better outcome
Measured: 6&12 weeks
11 Point Pain Numerical Rating Scale (NRS): Global disease activity over the past 1 week
Minimum score '0' to maximum score '10' Lower numerical value is the better outcome
Measured: 6&12 weeks
11 point pain Numerical Rating Scale (NRS): Satisfaction with index knee function over the past 1 week
Minimum score '0' to maximum score '10' Lower numerical value is the better outcome
Measured: 6&12 weeks
11 point pain Numerical Rating Scale (NRS): Average pain in other joints over the past 1 week
Minimum score '0' to maximum score '10' Lower numerical value is the better outcome
Measured: 6&12 weeks
Pain in other joints
Joint manikin
Measured: 6&12 weeks
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)
Self-Assessment
Measured: 6&12 weeks
Rescue analgesics/NSAIDs
Use of rescue analgesics/NSAIDs
Measured: 6&12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 May 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds
- Responsible party
- Sponsor
- Investigators
- Alexander MacGregor, PhD, Study director, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878368
- Sponsor's protocol ID
- BRIO Protocol V4.0
- Acronym
- BRIO
- Status last verified
- Oct 2021
- First submitted
- 14 Mar 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dietary Intervention Trial to Examine the Effect of Broccoli Bioactives (Specifically Sulforaphane) on Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT03878368
- Acronym / sponsor ID
- BRIO / BRIO Protocol V4.0
- Conditions
- Osteoarthritis
- Keywords
- Sulforaphane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Sulforaphane32 participants with moderate osteoarthritis will eat soup with the active ingredient once-a-day for 4 days-a-week for 3 months. |
| Control | Active comparator | Dietary Supplement: Placebo32 participants with moderate osteoarthritis will eat soup without the active ingredient once-a-day for 4 days-a-week for 3 months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
- 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.
- Kellgren Lawrence grade 2-3
- Stable analgesic usage (if using) for 4 weeks prior to trial entry and throughout the trial duration
- Able to adhere to the study visit schedule and other protocol requirements (willing to consume soup intervention).
Key exclusion criteria (14 listed)
- The presence of any inflammatory arthritis (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondylarthropathy) or fibromyalgia or metabolic bone disease.
- 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.
- 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.
- Use of an investigational product within 30 days prior to 'run in' period or active enrolment in another drug or vaccine clinical study.
- Significant knee injury or any knee surgery within the 6 months preceding enrolment in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SulforaphaneIntervention soup with dietary sulforaphane | Dietary supplement | Intervention |
| PlaceboControl soup without dietary sulforaphane | Dietary supplement | Control |
Primary outcome
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.
11 secondary outcomes
WOMAC (Western Ontario and McMaster Universities Arthritis Index): Pain
Time frame: 6 weeks
WOMAC (Western Ontario and McMaster Universities Arthritis Index): Physical Function
Time frame: 6 & 12 weeks
WOMAC (Western Ontario and McMaster Universities Arthritis Index): Stiffness
Time frame: 6 & 12 weeks
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
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
11 Point Pain Numerical Rating Scale (NRS): Global disease activity over the past 1 week
Time frame: 6&12 weeks
11 point pain Numerical Rating Scale (NRS): Satisfaction with index knee function over the past 1 week
Time frame: 6&12 weeks
11 point pain Numerical Rating Scale (NRS): Average pain in other joints over the past 1 week
Time frame: 6&12 weeks
Pain in other joints
Time frame: 6&12 weeks
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)
Time frame: 6&12 weeks
Rescue analgesics/NSAIDs
Time frame: 6&12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander MacGregor, PhD study director
University of East Anglia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulforaphane in people with Osteoarthritis, run by University of East Anglia at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (Western Ontario and McMaster Universities Arthritis Index) (time frame: Baseline and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.