Health TrialsbyHealthPanel

Radicle Energy™ DNB: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes

ConditionFatigue
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-105
SponsorRadicle Science

About this trial

Radicle Energy™ DNB: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on fatigue and related health outcomes

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities

Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed

Resides in the United States

Has the opportunity for at least 30% improvement in their primary health outcome

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active Fatigue Product 1A

    Dietary supplement

    Participants will use their Active Fatigue Product 1A as directed for a period of 8 weeks

  • Active Fatigue Product 1B

    Dietary supplement

    Participants will use their Active Fatigue Product 1B as directed for a period of 8 weeks

  • Placebo Fatigue Control 1A

    Dietary supplement

    Participants will use their Placebo Fatigue Control 1A as directed for a period of 8 weeks

  • Placebo Fatigue Control 1B

    Dietary supplement

    Participants will use their Placebo Fatigue Control 1B as directed for a period of 8 weeks

Treatment groups

1,320 Participants
are divided into 4 treatment groups
Group A: Active Product 1AExperimental treatment 1 intervention
Group B: Active Product 1BExperimental treatment 1 intervention
Group C: Placebo Control 1APlacebo comparator 1 intervention
Group D: Placebo Control 1BPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in fatigue

Change in fatigue: Difference in rates of change over time 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)

Time frame
9 weeks

Secondary outcomes

1

Change in sleep

Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)

Time frame
9 weeks
2

Change in cognitive function

Change in cognitive function: Difference in rates of change over time in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)

Time frame
9 weeks
3

Change in mental wellbeing

Change in mental wellbeing: Difference between rates of change over time in mental wellbeing score as assessed by World Health Organization-Five Well-Being Index (scale 0-25; where the higher scores correspond to better mental wellbeing)

Time frame
9 weeks

Other outcomes

1

Minimal clinically important difference (MCID) in fatigue

Minimal clinically important difference (MCID) in fatigue: Likelihood of experiencing minimal clinically important difference in fatigue score as assessed by PROMIS Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)

Time frame
9 weeks
2

Minimal clinically important difference (MCID) in sleep

Minimal clinically important difference (MCID) in sleep: Likelihood of experiencing minimal clinically important difference in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)

Time frame
9 weeks
3

Minimal clinically important difference (MCID) in cognitive function

Minimal clinically important difference (MCID) in cognitive function: Likelihood of experiencing minimal clinically important difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)

Time frame
9 weeks
4

Minimal clinically important difference (MCID) in mental wellbeing

Minimal clinically important difference (MCID) in mental wellbeing: Likelihood of experiencing minimal clinically important difference in mental wellbeing, as measured by World Health Organization-Five Well-Being Index (scale 0-25; where the higher scores correspond to better mental wellbeing)

Time frame
9 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radicle Science

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: