FatigueNCT06074627
Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes
A study testing Energy Active Study Product 1.1 Usage, Energy Active Study Product 1.2 Usage and Energy Active Study Product 1.3 Usage in people with Fatigue and Energy, run by Radicle Science at 1 site in United States.
Trial summary
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on fatigue and other health outcomes Read more about this study
- Who is it for?
- Ages 21 to 105 yearsHealthy volunteers can take part
- What is being tested?
- Energy Active Study Product 1.1 Usage, Energy Active Study Product 1.2 Usage and Energy Active Study Product 1.3 Usage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,189 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2023to 3 May 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, 21 years of age and older 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
- Endorses more energy as a primary desire
- Has the opportunity for at least 20% improvement in their primary health outcome score
- 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
- Unable to provide a valid US shipping address and mobile phone number
- Reports a diagnosis of liver or kidney disease
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- Unable to read and understand English
- Reports current enrollment in another clinical trial
Show all 10Show fewer
- Lack of reliable daily access to the internet
- Reports current use of chemotherapy or immunotherapy
- Reports taking medications that have a well-established moderate or severe interaction, or pose a substantial safety risk with the active ingredients studied: Anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products
- Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radicle™ Energy2: A Parallel Group, Randomized, Double-Blinded, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Fatigue and Other Health Outcomes
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on fatigue and other health outcomes
Read the detailed description
This is a parallel group, randomized, double-blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for more energy, (2) have the opportunity for meaningful improvement in their health outcome score, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.
Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
- Being tested
- Energy Placebo Control Form 1, Energy Active Study Product 1.1 Usage, Energy Active Study Product 1.2 Usage, Energy Active Study Product 1.3 Usage
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy Placebo Control Form 1Dietary supplement
Participants will use their Radicle Energy Placebo Control Form 1 as directed for a period of 6 weeks.
Energy Active Study Product 1.1 UsageDietary supplement
Participants will use their Radicle Energy Active Study Product 1.1 as directed for a period of 6 weeks.
Energy Active Study Product 1.2 UsageDietary supplement
Participants will use their Radicle Energy Active Study Product 1.2 as directed for a period of 6 weeks.
Energy Active Study Product 1.3 UsageDietary supplement
Participants will use their Radicle Energy Active Study Product 1.3 as directed for a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Energy Product Form 1 - control Receives: Dietary Supplement: Energy Placebo Control Form 1 |
| Active Product 1.1 | Experimental | Energy Product Form 1 - active product 1 Receives: Dietary Supplement: Energy Active Study Product 1.1 Usage |
| Active Product 1.2 | Experimental | Energy Product Form 1 - active product 2 Receives: Dietary Supplement: Energy Active Study Product 1.2 Usage |
| Active Product 1.3 | Experimental | Energy Product Form 1 - active product 3 Receives: Dietary Supplement: Energy Active Study Product 1.3 Usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue
Mean difference in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)
Measured: 6 weeks
Secondary outcomes (7)
Change in focus (cognitive function)
Mean difference in focus score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function)
Measured: 6 weeks
Change in sleep
Mean difference in sleep score as assessed by PROMIS Sleep Disturbance 4A (scale 4 to 20; where higher scores correspond to higher levels of sleep disturbance)
Measured: 6 weeks
Change in feelings of anxiety
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; where higher scores correspond to greater levels of anxiety)
Measured: 6 weeks
Minimal clinically important difference (MCID) in fatigue
Likelihood of experiencing MCID in fatigue score as assessed by PROMIS Fatigue 8A
Measured: 6 weeks
Minimal clinically important difference (MCID) in focus (cognitive function)
Likelihood of experiencing MCID in focus score as assessed by PROMIS Cognitive Function 4A
Measured: 6 weeks
Minimal clinically important difference (MCID) in sleep
Likelihood of experiencing MCID in sleep score as assessed by PROMIS Sleep Disturbance 4A
Measured: 6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
Likelihood of experiencing MCID in anxiety score as assessed by PROMIS Anxiety 4A
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start26 Sep 2023
- Primary completion22 Dec 2023
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- 1,189 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 Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074627
- Sponsor's protocol ID
- RADX-2304
- Status last verified
- Jul 2024
- First submitted
- 3 Oct 2023
- Last updated
- 10 Jul 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radicle™ Energy2: A Parallel Group, Randomized, Double-Blinded, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Fatigue and Other Health Outcomes
- ClinicalTrials.gov ID
- NCT06074627
- Acronym / sponsor ID
- RADX-2304
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,189 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 10 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, blinded, placebo-controlled study assessing the impact of health and wellness products on fatigue and other health outcomes
Detailed description
This is a parallel group, randomized, double-blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for more energy, (2) have the opportunity for meaningful improvement in their health outcome score, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.
Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. 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
- 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: Energy Placebo Control Form 1Energy Product Form 1 - control |
| Active Product 1.1 | Experimental | Dietary Supplement: Energy Active Study Product 1.1 UsageEnergy Product Form 1 - active product 1 |
| Active Product 1.2 | Experimental | Dietary Supplement: Energy Active Study Product 1.2 UsageEnergy Product Form 1 - active product 2 |
| Active Product 1.3 | Experimental | Dietary Supplement: Energy Active Study Product 1.3 UsageEnergy Product Form 1 - active product 3 |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults, 21 years of age and older 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
- Endorses more energy as a primary desire
- Has the opportunity for at least 20% improvement in their primary health outcome score
- 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 (10 listed)
- Reports being pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address and mobile phone number
- Reports a diagnosis of liver or kidney disease
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- Unable to read and understand English
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 |
|---|---|---|
| Energy Placebo Control Form 1Participants will use their Radicle Energy Placebo Control Form 1 as directed for a period of 6 weeks. | Dietary supplement | Placebo Control 1 |
| Energy Active Study Product 1.1 UsageParticipants will use their Radicle Energy Active Study Product 1.1 as directed for a period of 6 weeks. | Dietary supplement | Active Product 1.1 |
| Energy Active Study Product 1.2 UsageParticipants will use their Radicle Energy Active Study Product 1.2 as directed for a period of 6 weeks. | Dietary supplement | Active Product 1.2 |
| Energy Active Study Product 1.3 UsageParticipants will use their Radicle Energy Active Study Product 1.3 as directed for a period of 6 weeks. | Dietary supplement | Active Product 1.3 |
Primary outcome
Change in fatigue
Time frame: 6 weeks
Mean difference in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)
7 secondary outcomes
Change in focus (cognitive function)
Time frame: 6 weeks
Change in sleep
Time frame: 6 weeks
Change in feelings of anxiety
Time frame: 6 weeks
Minimal clinically important difference (MCID) in fatigue
Time frame: 6 weeks
Minimal clinically important difference (MCID) in focus (cognitive function)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in sleep
Time frame: 6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
Time frame: 6 weeks
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 10 Jul 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.
Related trials for Fatigue
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
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 Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Active Study Product 1.1 Usage, Energy Active Study Product 1.2 Usage and Energy Active Study Product 1.3 Usage in people with Fatigue and Energy, 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 10 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 10 Jul 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 fatigue (time frame: 6 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 10 Jul 2024.