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?

This trial explores whether an anti-inflammatory diet can improve symptoms in people with osteoarthritis, a condition that causes joint pain and stiffness. Researchers aim to determine if this diet affects how people feel and how their bodies respond at a cellular level, including changes in gut health. Participants will follow either an anti-inflammatory diet (also known as the Mediterranean Diet) or a healthy diet to compare results. Ideal candidates for this study have knee osteoarthritis visible on an X-ray, have not changed their treatment in the past three months, and are open to trying a new diet. As an unphased trial, this study offers a unique opportunity to understand dietary impacts on osteoarthritis without the constraints of traditional clinical trial phases.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that eating an anti-inflammatory diet, such as the Mediterranean diet, links to a lower risk of developing osteoarthritis and experiencing milder symptoms. Observational studies have found that people who follow this diet often experience less inflammation, which is important because inflammation can worsen osteoarthritis.

For those considering a healthy diet, similar benefits appear. Studies suggest that a healthy diet can lower levels of C-reactive protein, an inflammation marker in the body. Reducing this marker can help manage osteoarthritis symptoms.

Current evidence indicates that both types of diets are safe and well-tolerated. There are no major reports of negative effects from following these diets. Overall, these dietary approaches seem to be a safe option for managing osteoarthritis symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for osteoarthritis, which often include medications like NSAIDs and corticosteroids, the anti-inflammatory diet focuses on reducing inflammation through food choices. This diet is unique because it emphasizes whole foods rich in antioxidants and omega-3 fatty acids, which can naturally reduce inflammation and potentially improve joint health. Researchers are excited about this approach because it offers a non-drug alternative that might not only help alleviate symptoms but also contribute to overall health without the side effects associated with many medications.

What evidence suggests that this trial's treatments could be effective for Osteoarthritis?

Research shows that an anti-inflammatory diet can help people with osteoarthritis (OA). Studies have found that this type of diet can reduce pain and improve mobility in those with OA. It also aids in weight control, which is crucial since losing weight can ease OA symptoms. Observations have linked the Mediterranean diet, a well-known anti-inflammatory diet, to a lower risk of developing OA and milder symptoms. In this trial, participants will follow either an anti-inflammatory diet or a healthy diet to evaluate their effects on OA. These findings suggest that an anti-inflammatory diet may positively affect OA. ^{1 2 6 7 8}

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

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]

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]

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]

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]

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]

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]

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]

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