Anti-inflammatory Diet for Osteoarthritis

Overseen By Monica Guma, M.D., PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Corticosteroids, Fish oils

Disqualifiers: Knee surgery, Rheumatoid arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

72 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{2 5 6 7 8}

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. ^{5 6 9 10 11}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Arm_2 Experimental Treatment 1 Intervention

Healthy Diet

Group II: Arm_1 Active Control 1 Intervention

Anti-inflammatory Diet

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 4,358 participants with a mean age of 61.2 years, those who adhered more closely to the Mediterranean diet had a significantly lower prevalence of knee osteoarthritis (OA), with 25.2% in the highest adherence group compared to 33.8% in the lowest.

Logistic regression analysis indicated that participants with the highest adherence to the Mediterranean diet had a 17% lower odds of having knee OA (OR 0.83), suggesting that dietary choices may play a role in managing or preventing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to a Mediterranean diet is associated with lower prevalence of osteoarthritis: Data from the osteoarthritis initiative. Veronese, N., Stubbs, B., Noale, M., et al.[2021]

The Mediterranean diet (MeDi) is associated with improved health outcomes and may help reduce the risk of non-communicable diseases (NCDs), as summarized from 33 articles including systematic reviews and meta-analyses.

Combining the MeDi with physical activity and avoiding tobacco and excessive alcohol consumption enhances its health benefits, suggesting a comprehensive approach to promoting better health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet and health outcomes: a systematic meta-review. Martinez-Lacoba, R., Pardo-Garcia, I., Amo-Saus, E., et al.[2019]

The anti-inflammatory diet, inspired by the Mediterranean and Okinawan diets, promotes a plant-based lifestyle that can significantly reduce the risk of various health issues, including cardiovascular disease, diabetes, and certain cancers in adults.

Emerging evidence suggests that this diet also benefits children by improving conditions like obesity, asthma, and academic performance, and even positively impacts infants when followed by mothers during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Anti-Inflammatory Diet. Mascarenhas, MR.[2019]

The Mediterranean diet, rich in plant-based foods and healthy fats like olive oil, has been shown to provide protective benefits against various diseases, including cardiovascular diseases, diabetes, obesity, arthritis, and cancer.

This diet's anti-inflammatory effects, particularly from components in extra virgin olive oil such as oleic acid and phenolic compounds, can help reduce disease activity, pain, and stiffness in patients with inflammatory arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The mediterranean diet model in inflammatory rheumatic diseases]. Sales, C., Oliviero, F., Spinella, P.[2022]

In a study of 543 participants at high risk for cardiovascular disease, urinary polyphenol excretion was found to be inversely associated with the dietary inflammatory index, suggesting that higher polyphenol levels indicate a more anti-inflammatory diet, particularly in women.

The research also showed that higher urinary polyphenol levels were linked to improvements in metabolic syndrome status, indicating that polyphenols could serve as a biomarker for anti-inflammatory diet consumption and its beneficial effects on health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total urinary polyphenol excretion: a biomarker of an anti-inflammatory diet and metabolic syndrome status. Arancibia-Riveros, C., Domínguez-López, I., Tresserra-Rimbau, A., et al.[2023]

In a study of 345 middle-aged male twins, adherence to the Mediterranean diet was linked to significantly lower levels of interleukin-6, a marker of inflammation, suggesting that this diet may help reduce systemic inflammation and cardiovascular risk.

The findings indicate that genetic or familial factors do not significantly influence the relationship between the Mediterranean diet and inflammation, as the strong association was primarily observed within pairs of twins rather than between them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the mediterranean diet is inversely associated with circulating interleukin-6 among middle-aged men: a twin study. Dai, J., Miller, AH., Bremner, JD., et al.[2021]

Patients with rheumatoid arthritis (RA) following a Mediterranean diet showed significant improvements in disease activity, physical function, and vitality over 12 weeks, with a notable decrease in the disease activity score (DAS28) by 0.56 (p<0.001).

In contrast, patients on a Western diet did not experience significant changes, highlighting the potential of the Mediterranean diet as an effective dietary intervention for managing RA symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An experimental study of a Mediterranean diet intervention for patients with rheumatoid arthritis. Sköldstam, L., Hagfors, L., Johansson, G.[2022]

In a study of 4,330 participants over 4 years, higher adherence to the Mediterranean diet was linked to a lower risk of worsening knee pain, suggesting potential benefits for individuals at risk of knee osteoarthritis (OA).

Among those free from symptomatic knee OA at the start, greater adherence to the Mediterranean diet was associated with a 9% reduced risk of developing symptomatic knee OA during the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet and knee osteoarthritis outcomes: A longitudinal cohort study. Veronese, N., Koyanagi, A., Stubbs, B., et al.[2021]

Citations

1. France pubmed.ncbi.nlm.nih.gov

Effect of a Mediterranean Type Diet on Inflammatory and Cartilage Degradation Biomarkers in Patients with Osteoarthritis. [2018]

2. India pubmed.ncbi.nlm.nih.gov

Effects of a Mediterranean Diet Compared with the Low-Fat Diet on Patients with Knee Osteoarthritis: A Randomized Feeding Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of the Mediterranean diet with and without weight loss on markers of inflammation in men with metabolic syndrome. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Adherence to a Mediterranean diet is associated with lower prevalence of osteoarthritis: Data from the osteoarthritis initiative. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Mediterranean diet and health outcomes: a systematic meta-review. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Pediatric Anti-Inflammatory Diet. [2019]

7. Italy pubmed.ncbi.nlm.nih.gov

[The mediterranean diet model in inflammatory rheumatic diseases]. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Total urinary polyphenol excretion: a biomarker of an anti-inflammatory diet and metabolic syndrome status. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Adherence to the mediterranean diet is inversely associated with circulating interleukin-6 among middle-aged men: a twin study. [2021]

10. England pubmed.ncbi.nlm.nih.gov

An experimental study of a Mediterranean diet intervention for patients with rheumatoid arthritis. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Mediterranean diet and knee osteoarthritis outcomes: A longitudinal cohort study. [2021]