Effect of Anti-inflammatory Diet in Osteoarthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06080347
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of California, San Diego
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee
Arms & Interventions

Arms

Active Comparator: Arm_1

Anti-inflammatory Diet

Experimental: Arm_2

Healthy Diet

Interventions

Other: - Anti-inflammatory Diet

Dietary intervention

Other: - Healthy Diet

Dietary intervention

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, San Diego, California

Status

Recruiting

Address

University of California

San Diego, California, 92122

Site Contact

Monica Guma, M.D, PHD

[email protected]

8588226523