Broccoli in osteoarthritis
| ISRCTN | ISRCTN11629849 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11629849 |
| ClinicalTrials.gov number | NCT03878368 |
| Secondary identifying numbers | BRIO Research Protocol V4.0 (01/08/2019) |
- Submission date
- 11/01/2019
- Registration date
- 26/02/2019
- Last edited
- 05/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
The aim of this study is to find out if eating broccoli will improve pain and physical function in osteoarthritis. A naturally occurring compound sulforaphane (SFN), found in broccoli, has been shown to protect articular cartilage in our laboratory studies of osteoarthritis. We also know that by eating broccoli, SFN gets into our joint tissues. The study will compare broccoli soup (rich in SFN) with a soup that does not contain broccoli (control), but looks and tastes the same.
Who can participate?
Patients aged over 50 who have osteoarthritis (OA) and pain in at least one knee, who like broccoli
What does the study involve?
Participants are randomly allocated to either the broccoli or the control soup and eat this on 4 days per week for 3 months. Pain and physical function are measured at the start of the study, at 6 weeks and at 12 weeks. Blood and urine samples are also collected.
What are the possible benefits and risks of participating?
Given that this is a pilot trial, the researchers cannot be sure that there will be any medical benefits to taking part in this study and they do not anticipate any risks.
Where is the study run from?
This study is run by the University of East Anglia through two sites. The two trial sites are Norfolk and Norwich University Hospital (Norwich) and Chapel Allerton Hospital (Leeds) (UK)
When is the study starting and how long is it expected to run for?
April 2018 to September 2021 (updated 05/05/2021, previously: June 2020)
Who is funding the study?
Versus Arthritis (formerly Arthritis Research UK) and Action Arthritis
Who is the main contact?
1. Dr Rose Davidson
brio.study@uea.ac.uk
2. Prof Alex MacGregor
a.macgregor@uea.ac.uk
Contact information
Public
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
| Phone | +44 (0)1603591789 |
|---|---|
| R.Davidson@uea.ac.uk |
Scientific
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
| Phone | +44 (0)1603591789 |
|---|---|
| R.Davidson@uea.ac.uk |
Study information
| Study design | Pilot-scale clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | A dietary intervention trial to examine the effect of broccoli bioactives (specifically sulforaphane) on osteoarthritis (OA) |
| Study acronym | BRIO |
| Study objectives | To determine whether dietary sulforaphane (SFN), naturally available from eating broccoli, improves pain in people with knee OA. |
| Ethics approval(s) | Approved 24/01/2019, East of England - Cambridge East Research Ethics Committee, The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, Tel: +44 (0)207 104 8101 or +44 (0)207 104 8095, Email: NRESCommittee.EastofEngland-CambridgeEast@nhs.net, ref: 19/EE0007 |
| Health condition(s) or problem(s) studied | Osteoarthritis |
| Intervention | Eligible, consented participants will be randomised on a 1:1 basis to one of two trial arms using a web-based randomisation process. The randomisation scheme will be generated by the Norwich Clinical Trials Unit data manager. Allocation will be stratified by centre (NNUH/CAH), gender (male/female) and age (<=60 / >60) using permuted block randomisation with randomly varying block sizes of 2 and 4. 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 patients with moderate osteoarthritis will either have the broccoli or the control soup, chosen at random. They will eat the soup once a day for 4 days a week for 3 months. Pain and physical function will be measured at the start of the trial, at 6 weeks and at 12 weeks, and blood and urine samples are collected to measure SFN levels. |
| Intervention type | Other |
| Primary outcome measure | Pain measured using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) pain subscale, at baseline, 6 weeks, and 12 weeks |
| Secondary outcome measures | 1. Pain and function in the knee measured using an 11-point NRS (Numerical Rating Scale) at baseline, 6 weeks, and 12 weeks for: 1.1. Average overall knee pain severity in the index knee over the past 1 week 1.2. Worst knee pain severity in the index knee over the past 1 week 1.3. Global disease activity over the past 1 week 1.4. Satisfaction with index knee function over the past 1 week 1.5. Average pain in other joints over the past 1 week 2. Pain measured in other joints (joint manikin) at baseline, 6 weeks, and 12 weeks 3. Pain measured using Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP), at baseline, 6 weeks, and 12 weeks 4. Use of rescue analgesics/NSAIDs at baseline, 6 weeks, and 12 weeks |
| Overall study start date | 02/04/2018 |
| Completion date | 01/09/2021 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 64 |
| Key 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 |
| Key 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 Removed 11/10/2019: 15. Smokers or those ceasing <3 months ago |
| Date of first enrolment | 01/05/2019 |
| Date of final enrolment | 31/05/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Norwich
NR4 7UY
United Kingdom
Leeds
LS7 4SA
United Kingdom
Sponsor information
University/education
Norwich Research Park
Norwich
NR4 7TJ
England
United Kingdom
| Phone | +44 (0)1603 591574 |
|---|---|
| researchsponsor@uea.ac.uk | |
"ROR" |
https://ror.org/026k5mg93 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Results of the study will be presented at relevant clinical meetings and published in an appropriate peer reviewed journal. Participants will be offered the opportunity to be informed of the study results. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
05/05/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2020 to 31/05/2021.
2. The overall end date was changed from 01/06/2020 to 01/09/2021.
3. The intention to publish date was changed from 01/06/2021 to 01/06/2022.
4. The plain English summary was updated to reflect these changes.
5. The recruitment resumed.
09/07/2020: The trial contact details have been made publicly visible.
17/04/2020: Due to current public health guidance, recruitment for this study has been paused.
11/10/2019: The following changes were made to the trial record:
1. Trial website and ClinicalTrials.gov number added.
2. Protocol/serial number updated from 'BRIO Research Protocol V1.0 (22/11/2018)' to 'BRIO Research Protocol V4.0 (01/08/2019)'.
3. The exclusion criteria were updated.
4. The recruitment start date was changed from 01/03/2019 to 01/05/2019.
5. The recruitment end date was changed from 01/11/2019 to 30/04/2020.
