Anti-inflammatory Diet for Knee Osteoarthritis

Overseen By Monica Guma, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Food allergies, pregnancy

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an anti-inflammatory diet, known as the ITIS diet, can aid individuals with knee osteoarthritis. Researchers aim to determine if this diet can improve symptoms and biological markers in patients. Those diagnosed with knee osteoarthritis who have not changed their treatment in the last three months may qualify for this study. Participants must not have any food allergies. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future dietary recommendations for knee osteoarthritis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you haven't changed your treatment in the last 3 months. This suggests you may need to continue your current medications without changes.

What prior data suggests that the ITIS diet is safe for knee osteoarthritis?

Research has shown that the ITIS diet, similar to the Mediterranean diet, is generally safe for individuals with conditions like rheumatoid arthritis and osteoarthritis. Studies have found that the Mediterranean diet is linked to reduced pain and a lower risk of worsening knee osteoarthritis. Additionally, this diet helps reduce inflammation and is considered safe for many. Therefore, for those considering joining a trial for the ITIS diet, the safety evidence appears promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for knee osteoarthritis, which often involve pain relievers like NSAIDs or corticosteroid injections, the ITIS diet offers a nutritional approach to managing inflammation. This anti-inflammatory diet is unique because it focuses on reducing inflammation through dietary changes rather than pharmaceutical interventions. Researchers are excited about this treatment because it could provide a natural, non-invasive option that avoids the side effects often associated with medications. Additionally, the ITIS diet might improve overall health and well-being, offering benefits beyond just joint pain relief.

What evidence suggests that the ITIS diet might be an effective treatment for knee osteoarthritis?

Research has shown that following a Mediterranean diet can reduce pain and symptoms in people with knee osteoarthritis. One study found that 129 patients who followed this diet for 12 weeks reported significantly less pain. Another study discovered that individuals adhering to this diet had a 9% lower risk of developing symptoms. In this trial, participants will follow the ITIS diet, a special version of the Mediterranean diet that also supports the gut microbiome, the collection of bacteria in the gut, and can improve outcomes in inflammatory conditions. Overall, these findings suggest that an anti-inflammatory diet like the ITIS diet could help manage knee osteoarthritis. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals diagnosed with knee osteoarthritis who haven't changed their treatment in the past three months. It's not suitable for those with food allergies or pregnant women.

Inclusion Criteria

I have knee osteoarthritis and my treatment hasn't changed in the last 3 months.

Exclusion Criteria

History of food allergies

Pregnancy

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 (ITIS) diet for 28 days

4 weeks

Follow-up

Participants are monitored for changes in pain and biological markers after dietary intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ITIS diet

Trial Overview The study investigates the impact of an anti-inflammatory diet, referred to as ITIS diet, on both clinical outcomes and biological markers in patients suffering from knee osteoarthritis.

How Is the Trial Designed?

Group I: ITIS diet Experimental Treatment 1 Intervention

anti-inflammatory (ITIS) diet for 28 days

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

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]

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]

In a study of 60 overweight and obese women with knee osteoarthritis, an anti-inflammatory diet combined with a low-calorie diet led to significantly greater weight loss and improvements in pain, functional status, depression, and anxiety compared to a standard low-calorie diet over two months.

Participants on the anti-inflammatory diet reported better quality of life in terms of physical functioning and pain, highlighting the potential benefits of dietary interventions in managing knee osteoarthritis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an anti-inflammatory in comparison with a low caloric diet on physical and mental health in overweight and obese women with knee osteoarthritis: a randomized clinical trial. Dolatkhah, N., Toopchizadeh, V., Barmaki, S., et al.[2023]

In a study of 60 rheumatoid arthritis patients, those with high adherence to the Mediterranean diet showed significantly lower levels of inflammation and disease activity, as indicated by reduced C-reactive protein and disease activity scores.

The high adherence group also exhibited a healthier gut microbiota profile, with notable decreases in certain bacteria, suggesting that the Mediterranean diet may positively influence both disease outcomes and gut health in RA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Mediterranean Diet on Disease Activity and Gut Microbiota Composition of Rheumatoid Arthritis Patients. Picchianti Diamanti, A., Panebianco, C., Salerno, G., et al.[2020]

In a 12-week randomized trial involving 154 overweight and obese patients with rheumatoid arthritis, the Mediterranean diet (MD) significantly reduced disease activity scores (DAS 28) compared to a low-fat high-carbohydrate diet and control group, indicating better management of RA symptoms.

The MD led to a 76% reduction in DAS 28 scores, demonstrating its effectiveness in reducing pain and inflammation in RA patients, regardless of weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Pattern or Weight Loss: Which One Is More Important to Reduce Disease Activity Score in Patients with Rheumatoid Arthritis? A Randomized Feeding Trial. Sadeghi, A., Tabatabaiee, M., Mousavi, MA., et al.[2023]

In a study of 120 rheumatoid arthritis patients, those who adhered more closely to the Mediterranean Diet showed significantly lower disease activity and functional disability, as indicated by lower Disease Activity Score (DAS28-CRP), Rheumatoid Arthritis Impact of Disease (RAID), and Health Assessment Questionnaire (HAQ) scores.

Higher adherence to the Mediterranean Diet reduced the odds of having a higher DAS28 score by 70%, suggesting that dietary choices can play a crucial role in managing rheumatoid arthritis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mediterranean diet, and not dietary inflammatory index, is associated with rheumatoid arthritis disease activity, the impact of disease and functional disability. Charneca, S., Ferro, M., Vasques, J., et al.[2023]

In a study of 205 rheumatoid arthritis patients, adherence to the Mediterranean diet was linked to improved health outcomes, including better scores on the RA Impact of Disease (RAID), patient global assessment (PGA), and general health (GH).

While the Mediterranean diet showed potential benefits for overall well-being in RA patients, it did not significantly correlate with lower disease activity scores, suggesting that while diet may help with certain symptoms, it may not directly impact the severity of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Mediterranean diet and patient perception of rheumatoid arthritis. Ingegnoli, F., Schioppo, T., Scotti, I., et al.[2021]

In a study of 180 patients with relapsing-remitting multiple sclerosis (RRMS), following a modified Mediterranean diet (mMeD) for 6 months significantly reduced dietary inflammatory index (DII) scores, indicating improved dietary inflammation levels.

The mMeD also led to a notable decrease in fatigue severity, as measured by the Modified Fatigue Impact Scale (MFIS), while the traditional Iranian diet (TID) showed no significant changes in either dietary inflammation or fatigue levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Mediterranean diet v. traditional Iranian diet: efficacy of dietary interventions on dietary inflammatory index score, fatigue severity and disability in multiple sclerosis patients. Bohlouli, J., Namjoo, I., Borzoo-Isfahani, M., et al.[2022]

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]

Two patients with inflammatory arthritis showed clinical improvement on the Waianae diet, suggesting dietary changes can positively impact joint inflammation.

Fasting followed by a vegetarian diet may lead to sustained improvements in inflammation, potentially by altering gut bacteria, although it does not address the underlying immune issues related to these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dietary treatment of inflammatory arthritis: case reports and review of the literature. Danao-Camara, TC., Shintani, TT.[2005]

Citations

1. arthritis.org arthritis.org/health-wellness/healthy-living/nutrition/anti-inflammatory/itis-a-supercharged-mediterranean-diet-for-ra

ITIS: A Supercharged Mediterranean Diet for RA A new approach to a popular diet shows a positive effect on the microbiome, a key player in inflammatory arthritis severity and outcomes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6451631/

Mediterranean Diet and KNEE Osteoarthritis Outcomes In conclusion, our data suggest that, higher adherence to Mediterranean diet is associated with a lower risk of pain worsening and symptomatic forms of knee OA, ...

3. withpower.com withpower.com/trial/phase-osteoarthritis-9-2021-21583

Anti-inflammatory Diet for Knee Osteoarthritis In a study of 129 patients with knee osteoarthritis over 12 weeks, those following a Mediterranean diet experienced significantly greater reductions in pain ...

4. researchgate.net researchgate.net/publication/329404246_Mediterranean_Diet_and_Knee_Osteoarthritis_Outcomes_A_Longitudinal_Cohort_Study

Mediterranean Diet and Knee Osteoarthritis Outcomes In 2,994 people free from SxOA at baseline, higher adherence to a Mediterranean diet was associated with a lower risk for SxOA during follow-up by 9% (Q5 vs. Q1 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11614952/

Mediterranean diet and osteoarthritis: an update - PMC Several observational studies have reported that adherence to the Mediterranean diet is associated with a reduced risk of developing OA and with lower severity ...

6. arthritis.org arthritis.org/health-wellness/healthy-living/nutrition/healthy-eating/mediterranean-diet-for-osteoarthritis

Mediterranean Diet for Osteoarthritis Studies suggest that eating a Mediterranean diet can reduce inflammation in people with osteoarthritis (OA) and protect against weight gain, fracture risk and ...