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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06104891
Other study ID # RADX-2317
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 25, 2023
Est. completion date April 30, 2024

Study information

Verified date May 2024
Source Radicle Science
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized, double blind, placebo-controlled trial assessing the immediate impact of non-caffeinated supplements on energy levels and associated health outcomes


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.


Recruitment information / eligibility

Status Completed
Enrollment 264
Est. completion date April 30, 2024
Est. primary completion date October 26, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 105 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Recharge Placebo Control 1
Participants will use their Radicle Recharge Placebo Control 1 as directed for a period of 5 hours.
Recharge Active Study Product 1
Participants will use their Radicle Recharge Active Study Product 1 as directed for a period of 5 hours.
Recharge Active Study Product 2
Participants will use their Radicle Recharge Active Study Product 2 as directed for a period of 5 hours.
Recharge Active Study Product 3
Participants will use their Radicle Recharge Active Study Product 3 as directed for a period of 5 hours.

Locations

Country Name City State
United States Radicle Science, Inc Del Mar California

Sponsors (1)

Lead Sponsor Collaborator
Radicle Science

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 5 hours
Secondary 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" 5 hours
Secondary 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) 5 hours
Secondary Minimal clinically important difference (MCID) in energy Likelihood of experiencing MCID in energy score as assessed by Energy VAS 5 hours
Secondary Minimal clinically important difference (MCID) in cognitive function Likelihood of experiencing MCID in cognitive function score as assessed by PROMIS Cognitive Function - Abilities 4A 5 hours
Secondary Minimal clinically important difference (MCID) in fatigue Likelihood of experiencing MCID in fatigue score as assessed by Fatigue VAS 5 hours
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