Broccoli In Osteoarthritis

NCT03878368 | Completed DMC

• 1 other identifier: BRIO Protocol V4.0
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis

Keywords

Sulforaphane

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (11)

• WOMAC (Western Ontario and McMaster Universities Arthritis Index): Pain

  6 weeks

• WOMAC (Western Ontario and McMaster Universities Arthritis Index): Physical Function

  6 & 12 weeks

• WOMAC (Western Ontario and McMaster Universities Arthritis Index): Stiffness

  6 & 12 weeks

• 11 Point Pain Numerical Rating Scale (NRS): Average overall knee pain severity in the index knee over the past 1 week

  6&12 weeks

• 11 Point Pain Numerical Rating Scale (NRS): Worst knee pain severity in the index knee over the past 1 week

  6&12 weeks

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Sulforaphane DIETARY_SUPPLEMENT

Intervention soup with dietary sulforaphane

Intervention

Placebo DIETARY_SUPPLEMENT

Control soup without dietary sulforaphane

Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period
• Nutritional deficiency
• 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

Sponsors & Collaborators

• University of East Anglia: lead
• University of Leeds: collaborator

Study Sites (2)

Norfolk & Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Chapel Allerton Hospital

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Alexander MacGregor, PhD

  University of East Anglia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 17, 2022

Record last verified: 2021-10

Locations

GB (2)