Radicle Clarity DSTTM: A Study Assessing the Impact of Health and Wellness Products on Mental Clarity and Related Health Outcomes

Официальное название

Radicle Clarity DSTTM: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Mental Clarity and Related Health Outcomes

Обзор

Radicle Clarity DSTTM: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on mental clarity and related health outcomes.

Подробное описание

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.

Self-reported data are collected electronically from eligible participants for 12 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Вмешательства

• Пищевая добавка Clarity Product Placebo Control
  Participants will use their Clarity Product Placebo Control as directed for a period of 12 weeks.
• Пищевая добавка RS Clarity Active Product
  Participants will use their RS Clarity Active Product as directed for a period of 12 weeks

Первичные конечные точки

• Change in cognitive function [Срок оценки: 13 weeks]

Вторичные конечные точки (3)

• Change in fatigue [Срок оценки: 13 weeks]
• Change in sleep-related impairment [Срок оценки: 13 weeks]
• Change in cognitive abilities [Срок оценки: 13 weeks]

Критерии участия

Inclusion

Participants must meet all the following criteria:

• Adults, 35-60 years of age (inclusive) at the time of electronic consent, inclusive of all ethnicities, races, and gender identities

• 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

Exclusion

Individuals who report any of the following during screening may 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 at a 7th grade level
• 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.

• 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.

• 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 and/or pose a safety risk
• Lack of reliable daily access to the internet
• Reports current use of prescription medication(s) for cognitive enhancement
• Reports current regular cannabis use

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Radicle Science Inc. — Del Mar

Идентификаторы

NCT: NCT07342192 · RADX_P_2601_DST

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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