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Completed

NCT Number: NCT06104891

Radicle Recharge: A Study of Health and Wellness Products on Energy Levels and Other Health Outcomes

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

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Key information

Age range

21 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radicle Science, Inc

Del Mar, California, 92014, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recharge Placebo Control 1

Dietary Supplement

Participants will use their Radicle Recharge Placebo Control 1 as directed for a period of 5 hours.

Recharge Active Study Product 1

Dietary Supplement

Participants will use their Radicle Recharge Active Study Product 1 as directed for a period of 5 hours.

Recharge Active Study Product 2

Dietary Supplement

Participants will use their Radicle Recharge Active Study Product 2 as directed for a period of 5 hours.

Recharge Active Study Product 3

Dietary Supplement

Participants will use their Radicle Recharge Active Study Product 3 as directed for a period of 5 hours.

Primary outcomes

  1. Change in energy

    Time frame: 5 hours

    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)

Secondary outcomes

  1. Change in cognitive function

    Time frame: 5 hours

    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"

  2. Change in fatigue

    Time frame: 5 hours

    Mean difference in fatigue score as assessed by Fatigue VAS (scale 0 - 10; where 0 is no fatigue and 10 is completely exhausted)

  3. Minimal clinically important difference (MCID) in energy

    Time frame: 5 hours

    Likelihood of experiencing MCID in energy score as assessed by Energy VAS

  4. Minimal clinically important difference (MCID) in cognitive function

    Time frame: 5 hours

    Likelihood of experiencing MCID in cognitive function score as assessed by PROMIS Cognitive Function - Abilities 4A

  5. Minimal clinically important difference (MCID) in fatigue

    Time frame: 5 hours

    Likelihood of experiencing MCID in fatigue score as assessed by Fatigue VAS

Sponsors and collaborators

Lead sponsor

Radicle Science

Industry

Registry information

Official study title

Radicle Recharge™: A Randomized, Double-blind, Placebo-controlled Trial Assessing the Immediate Effects of Non-caffeinated Supplements on Energy Levels and Associated Health Outcomes

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 27, 2023
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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