Influence of Instaflex Joint Support Supplement on Joint Pain, Stiffness, Function, and Inflammation: a Randomized, Placebo-controlled Community Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Joint pain and function
研究概览
简要总结
The primary purpose of this study is to assess the effect of 8-weeks ingestion of the Instaflex Joint Support supplement (Direct Digital, Charlotte, NC) compared to placebo on joint pain, stiffness, and function (questionnaires and 6-min walk test) and blood inflammation biomarkers in adults with self-reported joint pain.
详细描述
Allocation: Randomized. Subjects will be randomized to one of two groups: placebo or Instaflex Joint Support. Supplements will be administered in double-blinded fashion.
Intervention Model: Instaflex Joint Support supplement for 8 weeks versus placebo.
Sample Size: N=100, with N=50 per group.
Statistical Procedures: 2 x 2 repeated measures analysis of variance (ANOVA).
Study Duration (per subject): 8 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •ages 50-75 years
- •history (>3 months) joint pain, knees, hip, ankles, shoulders, or hands
- •willingness to avoid NSAIDs use during the 8-week study
- •willingness to avoid other anti-inflammatory medications
- •agree to stay weight stable during the 8-week study
- •willing to follow all study procedures, including randomization to one of two groups
- •able to walk for at least 6 min at a moderate-to-brisk pace
排除标准
- •history of regular NSAID use during the previous two weeks
- •use of other medications (e.g., analgesic gels, arthritis medications, other anti-inflammatory drugs) or supplements (in particular, glucosamine and chondroitin) for joint pain for the previous two weeks
- •serious medical problems (current cancer case, severe rheumatoid arthritis, recent heart attack, recent stroke, congestive heart failure, ulcers, kidney disease, or other disease that will interfere with study participation).
- •psychiatric disorder or other condition that might interfere with self-assessment ability.
- •history of allergic reactions to shellfish products.
- •history of allergic reactions to products containing aspirin.
研究组 & 干预措施
Instaflex
Instaflex Joint Support supplement (3 capsules per day for 8 weeks)
干预措施: Instaflex (Dietary Supplement)
Placebo
Placebo (3 capsules per day for 8 weeks)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Joint pain and function
时间窗: Change in joint pain and function at 8 weeks
Assessed through questionnaires
次要结局
- Systemic inflammation(Change in systemic inflammation at 8 weeks)
- Safety(Change in safety outcomes at 8 weeks)