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RecruitingNCT06080347Updated Nov 4, 2024

Effect of Anti-inflammatory Diet in Osteoarthritis

An interventional study of Anti-inflammatory Diet and Healthy Diet in Osteoarthritis, Knee, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-04.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites. The current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with Osteoarthritis, and the role of microbiome and circulating metabolites.

02

Conditions studied

  • Osteoarthritis, Knee
03

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's planned enrollment of 72 is close to the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 975 studies on the registry; 196 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 71 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Unilateral radiographic symptomatic KOA
  • No changes in therapy during the previous 3 months
  • Interested in dietary intervention and able to provide consent and attend follow-up visits

Exclusion criteria

Exclusion Criteria:

  • Previous knee surgery
  • Severe radiographic disease (KL grade 4)
  • Rheumatoid Arthritis
  • Any Abnormal blood values in the comprehensive metabolic panel test at screen (Abnormality will be defined based on standard reference ranges)
  • Use of corticosteroids and/or intra-articular injections during the preceding 3 months
  • Use of fish oils and glucosamine
  • Participation in a weight loss program in the preceding 6 months
  • Recent changes in physical activity levels
  • Regular smoking
  • Patients with food allergies
  • Patient with other medical conditions that will impair the ability to participate in a nutritional study
  • Plan to change systemic therapy
  • Patients unwilling to change dietary habits
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Active comparator
    Arm_1

    Anti-inflammatory Diet

    Other: Anti-inflammatory Diet

  • Experimental
    Arm_2

    Healthy Diet

    Other: Healthy Diet

Interventions

  • OtherAnti-inflammatory Diet

    Dietary intervention

  • OtherHealthy Diet

    Dietary intervention

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What researchers measure

Primary outcomes

  1. Change in Knee Osteoarthritis Pain

    The Western Ontario and McMaster Universities Osteoarthritis Index, known as the WOMAC score, is a validated questionnaire used for evaluating pain, stiffness, and physical function in individuals with knee or hip osteoarthritis. A minimum score of 0 indicates no symptoms and a maximum score of 100, represents the most severe symptoms. Higher WOMAC scores correspond to worse outcomes, indicating more significant pain, stiffness, and functional limitations associated with osteoarthritis. The primary outcome for the purpose of this study will be the proportion of patients experiencing a change of at least 30% in WOMAC-pain score after 3 months of intervention compared to the control group.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • University of California
    San Diego, California 92122, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Jan 2026, 27 months after the start.

Of 1,143 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 27 months is above that.

Counting every sponsor, half of 1,285 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2023
First posted
Oct 12, 2023
StartActual
Oct 1, 2023
Primary completionEst.
Jan 1, 2026
CompletionEst.
Jan 1, 2026
Last update
Nov 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06080347
Responsible party
Monica Guma (Associate Professor, University of California, San Diego) — Principal investigator
First posted
Oct 12, 2023
Start date
Oct 1, 2023
Primary completion
Jan 1, 2026 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
Nov 4, 2024

Study contacts

Monica Guma, M.D., PhD
Contact
mguma@health.ucsd.edu
8588226523

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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