Change in LPS With Inulin Supplementation and Its Association With Knee Pain Among Older Adults With Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in serum lipopolysaccharide (LPS) concentration from baseline to 8 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Inulin and placebo are identical in appearance, taste, and packaging. Randomization is managed by the investigational pharmacy; study staff, investigators, and participants remain blinded.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Maltodextrin (Placebo) (Drug)
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.
干预措施: inulin (Drug)
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.
干预措施: inulin (Drug)
结局指标
主要结局
Change in serum lipopolysaccharide (LPS) concentration from baseline to 8 weeks
时间窗: Baseline and 8 weeks
Serum LPS levels will be measured at baseline and at 8 weeks to evaluate the effect of inulin supplementation compared to placebo.
Change in serum lipopolysaccharide (LPS) concentration from baseline to 8 weeks
时间窗: Baseline and 8 weeks
Serum LPS levels will be measured at baseline and at 8 weeks to evaluate the effect of inulin supplementation compared to placebo.
次要结局
- Change in serum LPS concentration between 10 g and 15 g inulin groups(Baseline and 8 weeks)
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline and 8 weeks)
- Change in serum LPS concentration between 10 g and 15 g inulin groups(Baseline and 8 weeks)
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline and 8 weeks)
研究者
Evelyn Hsieh Donroe
Associate Professor of Medicine
Yale University