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.
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 lipopolysaccharide (LPS) translocated from the gut microbiome may contribute to joint inflammation. Inulin-type fructans are non-digestible carbohydrates classified as prebiotic fibers. By modulating the gut microbiome, inulin has been shown to promote the growth of beneficial bacteria and to increase short-chain fatty acid (SCFA) production, which may help reduce systemic LPS levels and inflammation. This is a single-center, randomized, double-blind, placebo-controlled clinical trial of participants aged 40 years or older with radiographically confirmed knee OA and significant knee pain. Participants will be randomized in a 1:1:1 ratio to receive 10 g/day inulin, 15 g/day inulin, or placebo (maltodextrin) for 8 weeks. The primary outcome is change in serum LPS from baseline to 8 weeks in the combined inulin groups compared to placebo. The study hypothesis is that inulin supplementation will reduce circulating LPS and improve knee pain outcomes, supporting the role of gut microbiome modulation in the management of OA-related inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Inulin is a fermentable prebiotic fiber derived from chicory root. For this study, inulin is packaged into single-dose sachets containing 5 g, 10 g, or 15 g of powder. Participants in the 10 g arm escalate from 5 g/day for 3 days to 10 g/day, then continue with sachets containing a 2:1 blend of inulin and maltodextrin to provide a daily 10 g inulin dose. Participants in the 15 g arm escalate from 5 g/day for 3 days, 10 g/day for 4 days, then 15 g/day for the remaining 8 weeks. Sachets are mixed with food or beverage and taken once daily with the largest meal.
Maltodextrin is a carbohydrate powder widely used as a food additive. For this study, maltodextrin is used as the placebo comparator. It is packaged into single-dose sachets identical in appearance and taste to inulin sachets. Participants receive escalating doses (5 g/day for 3 days, 10 g/day for 4 days, then 15 g/day) for a total of 8 weeks. Sachets are mixed with food or beverage and taken once daily with the largest meal.
VA Connecticut Healthcare System, West Haven Campus
West Haven, Connecticut, United States
Change in serum lipopolysaccharide (LPS) concentration from baseline to 8 weeks
Serum LPS levels will be measured at baseline and at 8 weeks to evaluate the effect of inulin supplementation compared to placebo.
Time frame: Baseline and 8 weeks
Change in serum LPS concentration between 10 g and 15 g inulin groups
Dose-response effect of inulin supplementation on serum LPS levels.
Time frame: Baseline and 8 weeks
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Self-reported knee pain and function will be measured using the WOMAC scale. Higher scores indicate worse pain, stiffness, and functional limitations. Total possible score of 0-96.
Time frame: Baseline and 8 weeks
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