Radicle HealthTM VIP: A Study Assessing the Impact of Health and Wellness Products on Metabolic Health and Related Health Outcomes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-105
SponsorRadicle Science

About this trial

Radicle HealthTM VIP: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on metabolic health and related health outcomes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults, at least 21 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

  • Placebo Metabolic Control 1

    Dietary supplement

    Participants will use their Placebo Metabolic Control 1 as directed for a period of 24 weeks

  • Active Metabolic Product 1

    Dietary supplement

    Participants will use their Active Metabolic Product 1 as directed for a period of 24 weeks

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Active Metabolic Product 1Experimental treatment 1 intervention
Group B: Placebo Metabolic Control 1Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

HbA1c Metabolic

A metabolic test assessed by an at-home (direct-to-consumer) biospecimen (dried blood from a finger-prick) assay.

Time frame
27 weeks

Secondary outcomes

Other outcomes

1

Minimal clinically important difference in HbA1c metabolic

Odds of experiencing a (minimally) clinically important difference in metabolic testing assessed by evaluation of an at-home (direct-to-consumer) biospecimen (dried blood from a finger-prick) assay

Time frame
27 weeks
2

Wellbeing assessed by RAND SF-36

Wellbeing assessed by RAND SF-36: Difference between rates of change over time in wellbeing score as assessed by RAND SF-36(scale 1-5; where the higher scores correspond to higher impact on wellbeing) and (scale 1-3; where the higher scores correspond to lower impact on wellbeing)

Time frame
27 weeks
3

Blood glucose

Assessed by a Continuous Glucose Monitor (CGM)

Time frame
27 weeks

Sponsors and contacts

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

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