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NCT07189585

PHASE2

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

Sponsor: Yale University

View on ClinicalTrials.gov

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.

Official title: Change in LPS With Inulin Supplementation and Its Association With Knee Pain Among Older Adults With Osteoarthritis

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-01

Completion Date

2027-07-31

Last Updated

2025-09-24

Healthy Volunteers

Conditions

Knee Osteoarthritis

Interventions

DRUG

inulin

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.

DRUG

Maltodextrin (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.

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 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 Criteria: * 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

Locations (1)

VA Connecticut Healthcare System, West Haven Campus

West Haven, Connecticut, United States