EnergyNCT06104891
Radicle Recharge: A Study of Health and Wellness Products on Energy Levels and Other Health Outcomes
A study testing Recharge Active Study Product 1, Recharge Active Study Product 2 and Recharge Active Study Product 3 in people with Energy and Fatigue, run by Radicle Science at 1 site in United States.
Trial summary
A randomized, double blind, placebo-controlled trial assessing the immediate impact of non-caffeinated supplements on energy levels and associated health outcomes Read more about this study
- Who is it for?
- Ages 21 to 105 yearsHealthy volunteers can take part
- What is being tested?
- Recharge Active Study Product 1, Recharge Active Study Product 2 and Recharge Active Study Product 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Adults at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, sexes, and gender identities
- Attending the Supply Side West meeting in person
- Able to read and understand English
- Endorses more energy as a primary desire
- Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
Who cannot join
- Reports being pregnant, trying to become pregnant, or breastfeeding
- Reports current enrollment in another clinical trial
- Reports a cardiac disease that presents an absolute contraindication and/or a significant safety concern with any of the study product ingredients.
- Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study products ingredients: Anticoagulants, chemotherapy, immunotherapy, medications that warn against grapefruit consumption, oral diabetic medications, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
- Reports an allergy to any of the study products ingredients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radicle Recharge™: A Randomized, Double-blind, Placebo-controlled Trial Assessing the Immediate Effects of Non-caffeinated Supplements on Energy Levels and Associated Health Outcomes
A randomized, double blind, placebo-controlled trial assessing the immediate impact of non-caffeinated supplements on energy levels and associated health outcomes
Read the detailed description
This is a randomized, double blind. placebo-controlled study conducted with adult participants (study volunteers, citizen scientists), at least 21 years of age at the time of consent and attending the Supply Side West Meeting (SSW) this year.
Eligible participants will (1) endorse a desire for more energy and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known contraindication or with well-established, significant safety concerns due to illness and/or medication(s) will be excluded. Participants that report a known allergy to any possible ingredient they may be exposed to in one of the study arms will be excluded.
Participants will take their assigned study product at a Radicle booth, after enrolling.
Participant reported outcomes (PROs) are collected electronically from eligible participants at baseline (before study product consumption, and for a period of 5 hours after consuming their study product.
- Being tested
- Recharge Placebo Control 1, Recharge Active Study Product 1, Recharge Active Study Product 2, Recharge Active Study Product 3
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recharge Placebo Control 1Dietary supplement
Participants will use their Radicle Recharge Placebo Control 1 as directed for a period of 5 hours.
Recharge Active Study Product 1Dietary supplement
Participants will use their Radicle Recharge Active Study Product 1 as directed for a period of 5 hours.
Recharge Active Study Product 2Dietary supplement
Participants will use their Radicle Recharge Active Study Product 2 as directed for a period of 5 hours.
Recharge Active Study Product 3Dietary supplement
Participants will use their Radicle Recharge Active Study Product 3 as directed for a period of 5 hours.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Recharge Product Form 1 - control Receives: Dietary Supplement: Recharge Placebo Control 1 |
| Active Product 1 | Experimental | Recharge Product Form 2 - active product 1 Receives: Dietary Supplement: Recharge Active Study Product 1 |
| Active Product 2 | Experimental | Recharge Product Form 3 - active product 1 Receives: Dietary Supplement: Recharge Active Study Product 2 |
| Active Product 3 | Experimental | Recharge Product Form 4 - active product 1 Receives: Dietary Supplement: Recharge Active Study Product 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in energy
Mean difference in energy score as assessed by Energy Visual Analog Scale (VAS) (scale 0 - 10; where 0 is no energy and 10 is more than enough energy)
Measured: 5 hours
Secondary outcomes (5)
Change in cognitive function
Mean difference in cognitive function score as assessed by Patient Reported Outcome Measurement System (PROMIS) Cognitive Function - Abilities 4A (scale 4-20; where lower scores correspond to worse cognitive function). Modified timing to, "since walking this morning"
Measured: 5 hours
Change in fatigue
Mean difference in fatigue score as assessed by Fatigue VAS (scale 0 - 10; where 0 is no fatigue and 10 is completely exhausted)
Measured: 5 hours
Minimal clinically important difference (MCID) in energy
Likelihood of experiencing MCID in energy score as assessed by Energy VAS
Measured: 5 hours
Minimal clinically important difference (MCID) in cognitive function
Likelihood of experiencing MCID in cognitive function score as assessed by PROMIS Cognitive Function - Abilities 4A
Measured: 5 hours
Minimal clinically important difference (MCID) in fatigue
Likelihood of experiencing MCID in fatigue score as assessed by Fatigue VAS
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start25 Oct 2023
- Primary completion26 Oct 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnergyStudies 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
- Participants will be stratified based on gender at birth, then randomized to one of the study arms
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emily K. Pauli, PharmD, Principal investigator, Radicle Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104891
- Sponsor's protocol ID
- RADX-2317
- Status last verified
- May 2024
- First submitted
- 23 Oct 2023
- Last updated
- 20 May 2024
- 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 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radicle Recharge™: A Randomized, Double-blind, Placebo-controlled Trial Assessing the Immediate Effects of Non-caffeinated Supplements on Energy Levels and Associated Health Outcomes
- ClinicalTrials.gov ID
- NCT06104891
- Acronym / sponsor ID
- RADX-2317
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 27 Oct 2023 (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.
A randomized, double blind, placebo-controlled trial assessing the immediate impact of non-caffeinated supplements on energy levels and associated health outcomes
Detailed description
This is a randomized, double blind. placebo-controlled study conducted with adult participants (study volunteers, citizen scientists), at least 21 years of age at the time of consent and attending the Supply Side West Meeting (SSW) this year.
Eligible participants will (1) endorse a desire for more energy and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known contraindication or with well-established, significant safety concerns due to illness and/or medication(s) will be excluded. Participants that report a known allergy to any possible ingredient they may be exposed to in one of the study arms will be excluded.
Participants will take their assigned study product at a Radicle booth, after enrolling.
Participant reported outcomes (PROs) are collected electronically from eligible participants at baseline (before study product consumption, and for a period of 5 hours after consuming their study product.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Participants will be stratified based on gender at birth, then randomized to one of the study arms
| Arm | Type | Receives |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Dietary Supplement: Recharge Placebo Control 1Recharge Product Form 1 - control |
| Active Product 1 | Experimental | Dietary Supplement: Recharge Active Study Product 1Recharge Product Form 2 - active product 1 |
| Active Product 2 | Experimental | Dietary Supplement: Recharge Active Study Product 2Recharge Product Form 3 - active product 1 |
| Active Product 3 | Experimental | Dietary Supplement: Recharge Active Study Product 3Recharge Product Form 4 - active product 1 |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, sexes, and gender identities
- Attending the Supply Side West meeting in person
- Able to read and understand English
- Endorses more energy as a primary desire
- Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
Key exclusion criteria (5 listed)
- Reports being pregnant, trying to become pregnant, or breastfeeding
- Reports current enrollment in another clinical trial
- Reports a cardiac disease that presents an absolute contraindication and/or a significant safety concern with any of the study product ingredients.
- Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study products ingredients: Anticoagulants, chemotherapy, immunotherapy, medications that warn against grapefruit consumption, oral diabetic medications, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
- Reports an allergy to any of the study products ingredients
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 |
|---|---|---|
| Recharge Placebo Control 1Participants will use their Radicle Recharge Placebo Control 1 as directed for a period of 5 hours. | Dietary supplement | Placebo Control 1 |
| Recharge Active Study Product 1Participants will use their Radicle Recharge Active Study Product 1 as directed for a period of 5 hours. | Dietary supplement | Active Product 1 |
| Recharge Active Study Product 2Participants will use their Radicle Recharge Active Study Product 2 as directed for a period of 5 hours. | Dietary supplement | Active Product 2 |
| Recharge Active Study Product 3Participants will use their Radicle Recharge Active Study Product 3 as directed for a period of 5 hours. | Dietary supplement | Active Product 3 |
Primary outcome
Change in energy
Time frame: 5 hours
Mean difference in energy score as assessed by Energy Visual Analog Scale (VAS) (scale 0 - 10; where 0 is no energy and 10 is more than enough energy)
5 secondary outcomes
Change in cognitive function
Time frame: 5 hours
Change in fatigue
Time frame: 5 hours
Minimal clinically important difference (MCID) in energy
Time frame: 5 hours
Minimal clinically important difference (MCID) in cognitive function
Time frame: 5 hours
Minimal clinically important difference (MCID) in fatigue
Time frame: 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Radicle Science, IncLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will not be shared with researchers outside of Radicle Collaborators on this study.
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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. This study is not recruiting at the moment.
Emily K. Pauli, PharmD 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 Recharge Active Study Product 1, Recharge Active Study Product 2 and Recharge Active Study Product 3 in people with Energy and Fatigue, 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?
The sponsor lists 5 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 20 May 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in energy (time frame: 5 hours). 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 20 May 2024.