ACTRN12620001154998尚未招募3 期
Effect of a combined Krill and Greenshell Mussel (GSM) supplement on joint health and osteoarthritis in an older adult population: A double-blind randomized placebo-controlled parallel study.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 45 Years 至 o limit（—）
- 性别
- All
入选标准
- •Males and females aged over 45 years old inclusive
- •Diagnosed with osteoarthritis
- •Reporting joint pain (not associated with acute injury, long-standing disease or prescription medication use)
- •Otherwise healthy, BMI 18.5-34.9 kg/m2
- •Able to provide informed consent
- •Agree not to change current diet and exercise program
- •Access to internet
排除标准
- •Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland function malignancy)*
- •Malignancy (current) or treatment (chemotherapy and radiotherapy) for malignancy within the previous 2 years
- •Clinically significant acute or chronic inflammation, or connective tissue disease including, but not limited to rheumatoid arthritis, bursitis or gout.
- •Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy
- •Receiving treatment or taking supplements for joint pain/health such as glucosamine and omega-3 containing products#.
- •Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse
- •Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- •Allergic to seafood or any of the ingredients in the active or placebo formula
- •Known pregnant or lactating woman
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •Participants who have participated in any other related clinical study during the past 1 month
- •History of infection in the month prior to the study
- •*An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
- •#Potential participants that are taking supplements that would result in their exclusion must wait a 4-week washout period prior to commencing the study.
研究者
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