Change in LPS With Inulin Supplementation and Its Association With Knee Pain Among Older Adults With Osteoarthritis
Yale University
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 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.
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 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…
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- Druginulin
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.
- DrugMaltodextrin (Placebo)
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.
Location
- VA Connecticut Healthcare System, West Haven CampusWest Haven, Connecticut