Health TrialsbyHealthPanel

Radicle PerformanceTM VKN: 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
Age35-60
SponsorRadicle Science

About this trial

Radicle Performance™ VKN: A randomized, double-blind, placebo controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults, aged 35-60 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

Experiencing fatigue and/or perceiving a decline in sports performance due to tiredness

Resides in the United States

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo Health Performance Control

    Dietary supplement

    Participants will use their Placebo Health Performance Control as directed for a period of 4 weeks

  • Active Health Performance Product

    Dietary supplement

    Participants will use their Active Health Performance Product as directed for a period of 4 weeks

Treatment groups

650 Participants
are divided into 2 treatment groups
Group A: Active Health Performance Product 1Experimental treatment 1 intervention
Group B: Placebo Health Performance ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in fatigue

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
5 weeks

Secondary outcomes

1

Change in sleep

Sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)

Time frame
5 weeks
2

Change in feelings of stress

Stress score as assessed Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress)

Time frame
5 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
5 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
5 weeks
3

Minimal clinically important difference (MCID) in feelings of stress

Minimal clinically important difference (MCID) in feelings of stress: Likelihood of experiencing minimal clinically important difference in feelings of stress as assessed by Perceived Stress Scale (PSS-4) (scale 0-16; where lower scores correspond to less stress)

Time frame
5 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: