HydrationNCT07206979
An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health
A study testing Hydration Active Product 1, Hydration Active Product 2 and Hydration Active Product 3 in people with Hydration, run by Radicle Science at 1 site in United States.
Trial summary
An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health Read more about this study
- Who is it for?
- Ages 21 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration
- What is being tested?
- Hydration Active Product 1, Hydration Active Product 2 and Hydration Active Product 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Radicle Science Inc.
Del Mar, California, 92014
Study Manager, 760-281-3898, studymgmt@radiclescience.com
Megan Mosely, megan@radiclescience.com
About this study
An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health
Read the detailed description
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.
- Conditions
- Hydration
- Being tested
- Hydration Active Product 1, Hydration Active Product 2, Hydration Active Product 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydration Active Product 1Dietary supplement
Participants will use their Hydration Active Product 1 as directed for a period of 1 week.
Hydration Active Product 2Dietary supplement
Participants will use their Hydration Active Product 2 as directed for a period of 1 week.
Hydration Active Product 3Dietary supplement
Participants will use their Hydration Active Product 3 as directed for a period of 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Active Product 1 | Experimental | Hydration Active Product 1 Receives: Dietary Supplement: Hydration Active Product 1 |
| Active Product 2 | Experimental | Hydration Active Product 2 Receives: Dietary Supplement: Hydration Active Product 2 |
| Active Product 3 | Experimental | Hydration Active Product 3 Receives: Dietary Supplement: Hydration Active Product 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydration: Differences in self-reported perceptions of hydration
Hydration; Differences in self-reported perceptions of hydration as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of hydration)
Measured: 2 weeks
Secondary outcomes (8)
Energy: Differences in self-reported perceptions of energy
Energy; Differences in self-reported perceptions of energy as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of energy).
Measured: 2 weeks
Jitters: Differences in self-reported perceptions of jitters
Jitters; Differences in self-reported perceptions of jitters as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of jitters)
Measured: 2 weeks
Focus; Differences in self-reported perceptions of focus
Focus; Differences in self-reported perceptions of focus as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of focus)
Measured: 2 weeks
Productivity: Differences in self-reported perceptions of productivity
Productivity; Differences in self-reported perceptions of productivity as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of productivity)
Measured: 2 weeks
Confidence: Differences in self-reported perceptions of confidence
Confidence; Differences in self-reported perceptions of confidence as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of confidence).
Measured: 2 weeks
Interest in Socializing: Differences in self-reported perceptions of socialization
Interest in Socializing; Differences in self-reported perceptions of socialization as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of socialization)
Measured: 2 weeks
Feeling Rested: Differences in self-reported perceptions of restfulness
Feeling Rested; Differences in self-reported perceptions of restfulness as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of being rested)
Measured: 2 weeks
Quality of Sleep: Differences in self-reported perceptions of sleep quality
Quality of Sleep; Differences in self-reported perceptions of sleep quality assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater quality of sleep)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrationStudies of the same condition, open and under way.
- More trials run by Radicle ScienceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants completing pretest/baseline will be stratified based on their sex assignment at birth and age then randomized to one of the study groups sequentially based on all stratification measures collectively to ensure equal distribution to each study product group. Participants will be provided the study product and the study insert with instructions for use and study participation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Hewlings, Principal investigator, Radicle Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206979
- Sponsor's protocol ID
- RADX_OL_2505_LIV
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with researchers outside of Radicle Collaborators on this study.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health
- ClinicalTrials.gov ID
- NCT07206979
- Acronym / sponsor ID
- RADX_OL_2505_LIV
- Conditions
- Hydration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Eligible participants completing pretest/baseline will be stratified based on their sex assignment at birth and age then randomized to one of the study groups sequentially based on all stratification measures collectively to ensure equal distribution to each study product group. Participants will be provided the study product and the study insert with instructions for use and study participation.
| Arm | Type | Receives |
|---|---|---|
| Active Product 1 | Experimental | Dietary Supplement: Hydration Active Product 1Hydration Active Product 1 |
| Active Product 2 | Experimental | Dietary Supplement: Hydration Active Product 2Hydration Active Product 2 |
| Active Product 3 | Experimental | Dietary Supplement: Hydration Active Product 3Hydration Active Product 3 |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydration Active Product 1Participants will use their Hydration Active Product 1 as directed for a period of 1 week. | Dietary supplement | Active Product 1 |
| Hydration Active Product 2Participants will use their Hydration Active Product 2 as directed for a period of 1 week. | Dietary supplement | Active Product 2 |
| Hydration Active Product 3Participants will use their Hydration Active Product 3 as directed for a period of 1 week. | Dietary supplement | Active Product 3 |
Primary outcome
Hydration: Differences in self-reported perceptions of hydration
Time frame: 2 weeks
Hydration; Differences in self-reported perceptions of hydration as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of hydration)
8 secondary outcomes
Energy: Differences in self-reported perceptions of energy
Time frame: 2 weeks
Jitters: Differences in self-reported perceptions of jitters
Time frame: 2 weeks
Focus; Differences in self-reported perceptions of focus
Time frame: 2 weeks
Productivity: Differences in self-reported perceptions of productivity
Time frame: 2 weeks
Confidence: Differences in self-reported perceptions of confidence
Time frame: 2 weeks
Interest in Socializing: Differences in self-reported perceptions of socialization
Time frame: 2 weeks
Feeling Rested: Differences in self-reported perceptions of restfulness
Time frame: 2 weeks
Quality of Sleep: Differences in self-reported perceptions of sleep quality
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will not be shared with researchers outside of Radicle Collaborators on this study.
Related trials for Hydration
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Dietary Supplementation and Hydration
Hydration
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Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Enrolling by invitation
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
Low Back Pain (LBP), Fascial Manipulation
Recruiting
Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
Xerosis, Dry Skin
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Hewlings principal investigator
Radicle Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydration Active Product 1, Hydration Active Product 2 and Hydration Active Product 3 in people with Hydration, run by Radicle Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Manager (858-779-0086, studymgmt@radiclescience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydration: Differences in self-reported perceptions of hydration (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.