An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health

Обзор

An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health

Подробное описание

This is an open label study conducted with adult participants residing in the United States.

Eligible participants will (1) agree to consume a hydration product, (2) agree not to take any other hydration or electrolyte supplements for the duration of the trial, (3) be 21 years of age or older, and (4) agree to participate in this study for 2 week and answer assessments.

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 over 2 weeks. Participant reports of health indicators will be collected at screening and throughout the active period of study product use. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Вмешательства

• Пищевая добавка Hydration Active Product 1
  Participants will use their Hydration Active Product 1 as directed for a period of 1 week.
• Пищевая добавка Hydration Active Product 2
  Participants will use their Hydration Active Product 2 as directed for a period of 1 week.
• Пищевая добавка Hydration Active Product 3
  Participants will use their Hydration Active Product 3 as directed for a period of 1 week.

Первичные конечные точки

• Hydration: Differences in self-reported perceptions of hydration [Срок оценки: 2 weeks]

Вторичные конечные точки (8)

• Energy: Differences in self-reported perceptions of energy [Срок оценки: 2 weeks]
• Jitters: Differences in self-reported perceptions of jitters [Срок оценки: 2 weeks]
• Focus; Differences in self-reported perceptions of focus [Срок оценки: 2 weeks]
• Productivity: Differences in self-reported perceptions of productivity [Срок оценки: 2 weeks]
• Confidence: Differences in self-reported perceptions of confidence [Срок оценки: 2 weeks]
• Interest in Socializing: Differences in self-reported perceptions of socialization [Срок оценки: 2 weeks]
• Feeling Rested: Differences in self-reported perceptions of restfulness [Срок оценки: 2 weeks]
• Quality of Sleep: Differences in self-reported perceptions of sleep quality [Срок оценки: 2 weeks]

Критерии участия

3.1 Inclusion

Participants must meet all the following criteria:

• Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races.
• Resides in the United States.

3.2 Exclusion

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
• 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.

• 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 the current use of electrolyte and/or hydration supplements that may limit the effects of the study products.
• Lack of reliable daily access to the internet.

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: NCT07206979 · RADX_OL_2505_LIV

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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