Status:
NOT_YET_RECRUITING
Inulin Supplementation for Reducing Inflammation and Knee Pain in Older Adults With Osteoarthritis
Lead Sponsor:
Yale University
Collaborating Sponsors:
VA Connecticut Healthcare System
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
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 progr...
Detailed Description
Knee osteoarthritis (OA) is a leading cause of pain and disability among older adults. Low-grade systemic inflammation has been implicated in OA pathogenesis, and bacterial products such as lipopolysa...
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
Key Trial Info
Start Date :
April 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT07189585
Start Date
April 1 2026
End Date
July 31 2027
Last Update
September 24 2025
Active Locations (1)
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1
VA Connecticut Healthcare System, West Haven Campus
West Haven, Connecticut, United States, 06516