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

Conditions

• Knee Osteoarthritis

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• inulin — DRUG
  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 (Placebo) — DRUG
  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.

Study Details

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 Dates

Start date

Apr 1, 2026

Status verified

Sep 2025

Primary completion

Jul 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

84 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo (Maltodextrin)
  Participants receive maltodextrin powder in identical sachets. Dose is escalated over 2 weeks to match the dosing schedule of the inulin arms (5 g daily for 3 days, 10 g daily for 4 days, then 15 g daily). Sachets are mixed with food or beverage and taken once daily with the largest meal, for 8 weeks.
• Experimental: Inulin 10 g/day
  Participants receive inulin powder in identical sachets. Dose is escalated to 10 g daily (5 g daily for 3 days, then 10 g daily for 4 days). After Week 2, participants continue with one 15 g sachet containing a 2:1 blend of inulin and maltodextrin, providing a daily dose of 10 g inulin. Sachets are mixed with food or beverage and taken once daily with the largest meal, for 8 weeks.
• Experimental: Inulin 15 g/day
  Participants receive inulin powder in identical sachets. Dose is escalated to 15 g daily (5 g daily for 3 days, 10 g daily for 4 days, then 15 g daily). Sachets are mixed with food or beverage and taken once daily with the largest meal, for 8 weeks.

Primary Outcome Measure

Change in serum lipopolysaccharide (LPS) concentration from baseline to 8 weeks [ Time Frame: Baseline and 8 weeks ]

Central Contacts

• Evelyn Hsieh, MD, PhD
  (203) 785-7092
  [email protected]

Locations (1)

Find similar trials in West Haven, CT

Related Studies

• Evaluating the Efficacy of a Mobile Application in Postoperative Rehabilitation
  Recruiting · Yale University · New Haven, Connecticut
• Intra-articular Platelet-Rich Plasma Compared With Viscosupplementation in the Treatment of Knee Osteoarthritis
  PHASE2 · Recruiting · Endeavor Health · Skokie, Illinois
• Effects of Gait Retraining on Lower Extremity Biomechanics
  Recruiting · George Mason University · Manassas, Virginia
• Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
  Enrolling By Invitation · MicroPort Orthopedics Inc. · Englewood, Colorado