Ignite Creation Date:
2024-05-06 @ 12:53 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03878368
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2019-03-14
Brief Title:
Broccoli In Osteoarthritis
Sponsor:
University of East Anglia
Organization:
University of East Anglia
Study Overview
Official Title:
A Dietary Intervention Trial to Examine the Effect of Broccoli Bioactives Specifically Sulforaphane on Osteoarthritis OA
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRIO
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None