A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scoring. [Baseline to Week 12]
研究概览
简要总结
This is a hybrid, double-blind, randomized, placebo-controlled clinical trial that will last 12 weeks. Participants will be randomized into either the intervention product or control group and will consume the test product or control daily. Participants will complete study-specific and validated questionnaires at Baseline, Week 6, and Week 12, as well as blood biomarker testing for a lipid panel and high-sensitivity C-reactive protein (hs-CRP) at Baseline and Week 12.
Osteoarthritis-like symptoms, such as joint pain, inflammation, and reduced mobility will be evaluated at baseline and at each check-in. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores. Two validated questionnaires, Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Numeric Pain Rating Scale (NPRS) will also be completed at the questionnaire time points. A full lipid panel and hs-CRP measurement will be completed via in-person blood draws.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Both groups and the study coordinators will be blinded to the allocation.
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
- •Men and women aged 50-75 years of age
- •Self-reporting osteoarthritis-like symptoms, experiencing 3 or more of the following symptoms: joint pain, inflammation, reduced mobility, joint swelling, and stiffness.
- •Non-acute osteoarthritis, must have experienced symptoms for longer than 1 year.
- •Generally healthy and don't live with any uncontrolled chronic disease
- •Able to eat eggs (haven't been medically advised to avoid)
- •Willing to stop eating eggs for the 12 week study
排除标准
- •Anyone allergic or intolerant of eggs
- •Anyone who has been advised to avoid eggs
- •Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- •Anyone with known severe allergic reactions.
- •Women who are pregnant, breastfeeding or attempting to become pregnant
- •Unwilling to follow the study protocol.
- •Subjects currently enrolled in another clinical study
- •Subjects having finished another clinical study within the last 4 weeks before inclusion
- •Hypersensitivity, allergy, or intolerance against any compound of the test products (e. g. eggs)
- •Recent implantation of a cardiac pacemaker or other active implants
- •History of or present liver deficiency as defined by Quick < 70%
- •History of hepatitis B, C, HIV
- •Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations
- •Simultaneous study participation by members of the same household
- •Any diet to lose body weight
- •Eating disorders or vegan diet
- •Present drug abuse or alcoholism
研究组 & 干预措施
Fortetropin Group
The Fortetropin group will receive a 20cc size scoop with their product and will be instructed to mix 2 scoops of product with water or a milk of their choice daily.
干预措施: Fortetropin supplement (Other)
Control Group
The control group will receive a 50cc size scoop with their product and will be instructed to mix 2 scoops of product with water or a milk of their choice daily. The difference in scoop size is to allow for macronutrient matching of the intervention and control products.
干预措施: Cheese protein (Other)
结局指标
主要结局
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scoring. [Baseline to Week 12]
时间窗: 12 weeks
The WOMAC score is a widely used questionnaire-based assessment tool designed to evaluate the symptoms and functional limitations of individuals with osteoarthritis of the knee and hip joints. Patients are asked to rate their experience on a Likert scale, usually ranging from 0 to 4 or 5, where higher values indicate greater severity of symptoms or limitations.
Change in Numeric Pain Rating Scale (NPRS). [Baseline to Week 12]
时间窗: 12 weeks
The NPRS scale is a commonly used tool for assessing and quantifying pain intensity. It's a self-report scale where individuals are asked to rate their pain on a numerical scale. The scale typically ranges from 0 to 10, with 0 representing "no pain" and 10 representing "worst pain imaginable."
Changes in muscle mass perceived by participants. [Baseline to Week 12]
时间窗: 12 weeks
Survey-based assessment (0-5 scale) of participants perception of changes in muscle mass.
次要结局
- Changes in blood triglycerides. [Baseline to Week 12](12 weeks)
- Changes in High-Density Lipoprotein (HDL) cholesterol. [Baseline to Week 12](12 weeks)
- Changes in Low-Density Lipoprotein (LDL) cholesterol. [Baseline to Week 12](12 weeks)
- Changes in total cholesterol. [Baseline to Week 12](12 weeks)
- Changes in high-sensitivity C-reactive protein (hs-CRP). [Baseline to Week 12](12 weeks)