Inulin Supplementation for Reducing Inflammation and Knee Pain in Older Adults With Osteoarthritis

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Knee Osteoarthritis

In brief

This study will test whether inulin, a type of dietary fiber, can reduce inflammation in older adults with knee osteoarthritis. Inflammation in the body may contribute to both joint pain and the progression of osteoarthritis. Inulin is a prebiotic fiber that may improve gut health and reduce lipopolysaccharide (LPS), a marker of bacterial products in the blood that is linked to inflammation. In this trial, participants with knee osteoarthritis will be randomly assigned to receive either inulin or a placebo (maltodextrin) for 8 weeks. The study will measure changes in blood LPS levels, knee pain, and other markers of inflammation. The goal is to determine whether inulin supplementation can improve pain and reduce inflammation in people with knee osteoarthritis.

Key facts

Study ID

NCT07189585

Run by

Yale University

People needed

84

Starts

2026-11-01

Expected to finish

2027-07-31

Last updated by the study team

2026-07-07

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study (8 weeks).
• Male or female, aged ≥ 40 years.
• Established patient in the VA Connecticut Healthcare System
• At least one knee with pain severity in the past week ≥ 4/10 on numerical rating scale (NRS)
• Self-reported knee pain on most days of the prior month.
• Diagnosed with knee osteoarthritis (Kellgren-Lawrence grade 2-4 on radiographic imaging within the past 2 years).
• Ability to take oral powder supplements and willingness to adhere to the inulin/placebo daily regimen.
• Agreement to adhere to lifestyle considerations (see Section 5.3) throughout study duration, including maintenance of current diet, physical activity, and avoidance of new dietary supplements or complementary therapies.
• English-speaking and able to provide informed consent.
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to continue such method during study participation.

You may not qualify if…

• Current diagnosis of pre-diabetes (impaired glucose tolerance) or diabetes mellitus (Type 1 or Type 2).
• Use of antibiotics within the past 6 months.
• Current use of medications known to significantly impact the gut microbiome (e.g., proton pump inhibitors, disease-modifying antirheumatic drugs, GLP-1 receptor agonists).
• Use of anti-inflammatory dietary supplements (e.g., turmeric, omega-3 fatty acids) within the past 30 days.
• Participation in another interventional study or use of an investigational drug within the past 30 days.
• Current use of complementary or integrative therapies for knee OA including tai chi, acupuncture or yoga.
• Known allergy or intolerance to components of the study intervention, including inulin or maltodextrin.
• The presence of significant gastrointestinal disease that may interfere with the intervention or outcomes, such as inflammatory bowel disease or active peptic ulcer disease.
• Any medical, psychological, or behavioral condition that, in the opinion of the investigators, would place the participant at undue risk, interfere with study participation or adherence, or compromise data integrity.
• Current diagnosis of alcohol use disorder
• Pregnancy

Where it is running

• VA Connecticut Healthcare System, West Haven Campus — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.