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Inulin Supplementation for Knee Osteoarthritis

This study is testing if inulin, a type of fiber from chicory root, can help reduce inflammation and knee pain in older adults with knee osteoarthritis. Inflammation in your body might make joint pain worse and cause osteoarthritis to progress. Inulin is thought to improve gut health and lower levels of a substance called lipopolysaccharide (LPS) in the blood, which is linked to inflammation. You could be eligible if you are at least 40 years old, have knee osteoarthritis, and experience knee pain. Participants will receive either inulin or a placebo (maltodextrin) for 8 weeks. The main goal is to see if inulin can reduce LPS levels in the blood, and also to check for improvements in knee pain.

Study design
This is a randomized, double-blind, placebo-controlled study involving 84 participants. You would be randomly assigned to receive either inulin or a placebo, and neither you nor the study staff will know which you are receiving.
What's involved
You would take either inulin or a placebo daily for 8 weeks. Blood samples will be taken at the beginning and end of the 8-week period.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed for 8 weeks, with measurements taken at the start and end of this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07189585

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

Not Yet Recruiting
PHASE2Ages 40+InterventionalTreatment
Yale University
~84 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:inulinMaltodextrin (Placebo)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in serum lipopolysaccharide (LPS) concentration from baseline to 8 weeks
Measured over Baseline and 8 weeks

Conditions

Knee Osteoarthritis

Explore related trials

Osteoarthritis of knee

NCT07189585

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • VA Connecticut Healthcare System, West Haven Campus

    West Haven, Connecticutstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Evelyn Hsieh, MD, PhD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Evelyn Hsieh, MD, PhD
[email protected]
(203) 785-7092
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Change in serum lipopolysaccharide (LPS) concentration from baseline to 8 weeksBaseline and 8 weeks

    Serum LPS levels will be measured at baseline and at 8 weeks to evaluate the effect of inulin supplementation compared to placebo.