NCT07060898进行中（未招募）不适用
Radicle Clarity™ 25_RAM: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amazentis SA
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Cognitive function
研究概览
简要总结
This is a parallel group, randomized, double-blind, placebo-controlled clinical study assessing the safety and effects of a novel nutritional product on self-reported cognitive function and health in adults that reside in the USA. Participants will take their assigned study product (active or placebo) for 8 weeks and answer validated electronic surveys assessing cognitive function delivered to them through a text message (SMS) link or through email.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must meet all the following criteria:
- •Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
- •o Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
- •Resides in the United States
- •Has the opportunity for at least 30% improvement in their primary health outcome
- •Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
排除标准
- •Individuals who report any of the following during screening will be excluded from participation:
- •Report being pregnant, trying to become pregnant, or breastfeeding
- •Unable to provide a valid US shipping address and mobile phone number
- •Reports current enrollment in another clinical trial
- •Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- •Unable to read and understand English
- •Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
- •Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
- •o NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
- •Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
- •o Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
- •Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products
- •Lack of reliable daily access to the internet
研究组 & 干预措施
Active
Active Comparator
Novel nutritional product (containing Mitopure Urolithin A) targeting improvements in cognitive health
干预措施: Active Product (Dietary Supplement)
Placebo
Placebo Comparator
Identical Placebo product
干预措施: Placebo Product (Dietary Supplement)
结局指标
主要结局
Cognitive function
时间窗: 8 weeks
Change in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where higher scores correspond to better cognitive function)
次要结局
- Fatigue(8 weeks)
- Sleep-related impairment(8 weeks)
- Cognitive abilities(8 weeks)
- Cognitive function (brain health) via smartphone application assessments(8 weeks)
- Minimal clinically important difference (MCID) in cognitive function(8 weeks)
- Minimal clinically important difference (MCID) in fatigue(8 weeks)
- Minimal clinically important difference (MCID) in sleep(8 weeks)
- Minimal clinically important difference (MCID) in cognitive abilities(8 weeks)
- Adverse Events(8 weeks)
研究者
研究点 (1)
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