72 Participants Needed

Anti-inflammatory Diet for Osteoarthritis

MG
Overseen ByMonica Guma, M.D., PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you plan to change your systemic therapy or have used corticosteroids, intra-articular injections, fish oils, or glucosamine in the past 3 months.

What data supports the effectiveness of the treatment Anti-inflammatory Diet for Osteoarthritis?

Research shows that following a Mediterranean diet, which is a type of anti-inflammatory diet, can help reduce pain and improve physical function in people with knee osteoarthritis. This diet is also linked to lower levels of inflammation, which may help with osteoarthritis symptoms.12345

Is the anti-inflammatory diet safe for humans?

The anti-inflammatory diet, including the Mediterranean diet, is generally considered safe for humans and has been associated with various health benefits, such as reducing the risk of heart disease, diabetes, and obesity. It emphasizes plant-based foods, healthy fats like olive oil, and limited meat consumption, which are linked to its safety and positive effects.16789

How does the Anti-inflammatory Diet treatment differ from other treatments for osteoarthritis?

The Anti-inflammatory Diet, also known as the Mediterranean Diet, is unique because it focuses on eating plant-based foods, using olive oil as the main fat source, and consuming limited meat, which may help reduce inflammation and pain in osteoarthritis. Unlike typical medications, this diet leverages natural anti-inflammatory properties found in foods like extra virgin olive oil, which contains compounds that can help manage symptoms.1471011

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with one-sided symptomatic knee osteoarthritis who haven't altered their treatment in the last 3 months. They should be interested in dietary changes and able to attend follow-ups. Excluded are those on recent steroids/injections, changing physical activity or diet, smokers, severe knee damage, rheumatoid arthritis, abnormal blood tests, or other conditions affecting nutrition study participation.

Inclusion Criteria

I have knee pain on one side due to arthritis.
You are interested in altering your diet and willing to give consent as well as attend follow-up meetings.
My treatment has been the same for the last 3 months.

Exclusion Criteria

You have recently made significant changes in how much you exercise or move your body.
I have had knee surgery before.
You have other medical conditions that would make it difficult for you to take part in a nutrition study.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow an anti-inflammatory or healthy diet to assess its effect on osteoarthritis outcomes

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Anti-inflammatory Diet
  • Healthy Diet
Trial Overview The study examines if an anti-inflammatory diet can improve clinical outcomes for people with Osteoarthritis compared to a standard healthy diet. It also looks at how this diet might affect gut bacteria and body metabolites related to the disease.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm_2Experimental Treatment1 Intervention
Healthy Diet
Group II: Arm_1Active Control1 Intervention
Anti-inflammatory Diet

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Findings from Research

A Mediterranean diet over 16 weeks led to a significant reduction in the pro-inflammatory cytokine IL-1α by approximately 47% and a decrease in serum cartilage oligomeric matrix protein (sCOMP) by about 8%, indicating potential benefits in reducing inflammation and cartilage degradation in osteoarthritis patients.
Participants following the Mediterranean diet also experienced significant improvements in joint range of motion, specifically in knee flexion and hip rotation, suggesting that dietary changes can positively impact physical function in individuals with osteoarthritis.
Effect of a Mediterranean Type Diet on Inflammatory and Cartilage Degradation Biomarkers in Patients with Osteoarthritis.Dyer, J., Davison, G., Marcora, SM., et al.[2018]
In a study of 129 patients with knee osteoarthritis over 12 weeks, those following a Mediterranean diet experienced significantly greater reductions in pain compared to those on a low-fat or regular diet.
Both the Mediterranean and low-fat diets led to significant weight loss, but the Mediterranean diet was more effective in improving physical function and reducing pain severity, suggesting that its specific dietary components may play a crucial role in managing osteoarthritis symptoms.
Effects of a Mediterranean Diet Compared with the Low-Fat Diet on Patients with Knee Osteoarthritis: A Randomized Feeding Trial.Sadeghi, A., Zarrinjooiee, G., Mousavi, SN., et al.[2022]
The Mediterranean Diet (MedDiet) significantly reduced inflammation markers, such as plasma C-reactive protein (CRP) and interleukin levels, in men with metabolic syndrome, even without weight loss, indicating its anti-inflammatory properties.
Weight loss enhanced the MedDiet's effectiveness, as participants who lost more than 8.5 cm in waist circumference experienced greater reductions in inflammation markers, highlighting the combined benefits of diet and weight management.
Effect of the Mediterranean diet with and without weight loss on markers of inflammation in men with metabolic syndrome.Richard, C., Couture, P., Desroches, S., et al.[2017]

References

Effect of a Mediterranean Type Diet on Inflammatory and Cartilage Degradation Biomarkers in Patients with Osteoarthritis. [2018]
Effects of a Mediterranean Diet Compared with the Low-Fat Diet on Patients with Knee Osteoarthritis: A Randomized Feeding Trial. [2022]
Effect of the Mediterranean diet with and without weight loss on markers of inflammation in men with metabolic syndrome. [2017]
Adherence to a Mediterranean diet is associated with lower prevalence of osteoarthritis: Data from the osteoarthritis initiative. [2021]
Mediterranean diet and health outcomes: a systematic meta-review. [2019]
Pediatric Anti-Inflammatory Diet. [2019]
[The mediterranean diet model in inflammatory rheumatic diseases]. [2022]
Total urinary polyphenol excretion: a biomarker of an anti-inflammatory diet and metabolic syndrome status. [2023]
Adherence to the mediterranean diet is inversely associated with circulating interleukin-6 among middle-aged men: a twin study. [2021]
An experimental study of a Mediterranean diet intervention for patients with rheumatoid arthritis. [2022]
Mediterranean diet and knee osteoarthritis outcomes: A longitudinal cohort study. [2021]
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