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| Name | Class |
|---|---|
| University of Leeds | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulforaphane | Dietary Supplement | Intervention soup with dietary sulforaphane |
| |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC (Western Ontario and McMaster Universities Arthritis Index) | Change in the WOMAC (Western Ontario and McMaster Universities Arthritis Index) pain subscale. | Baseline and 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC (Western Ontario and McMaster Universities Arthritis Index): Pain | Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright | 6 weeks |
| WOMAC (Western Ontario and McMaster Universities Arthritis Index): Physical Function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander MacGregor, PhD | University of East Anglia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norfolk & Norwich University Hospital | Norwich | Norfolk | NR4 7UY | United Kingdom | ||
| Chapel Allerton Hospital |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C016766 | sulforaphane |
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| Placebo |
| Dietary Supplement |
Control soup without dietary sulforaphane |
|
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 |
| 6 & 12 weeks |
| WOMAC (Western Ontario and McMaster Universities Arthritis Index): Stiffness | Stiffness (2 items): after first waking and later in the day | 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 | 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 | 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 | 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 | 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 | 6&12 weeks |
| Pain in other joints | Joint manikin | 6&12 weeks |
| Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) | Self-Assessment | 6&12 weeks |
| Rescue analgesics/NSAIDs | Use of rescue analgesics/NSAIDs | 6&12 weeks |
| Leeds |
| West Yorkshire |
| LS7 4SA |
| United Kingdom |