A Clinical Study to Assess the Effects of JoyRise Recovery Powder on Mitigating Alcohol Aftereffects.

August 26, 2024 updated by: Joyrise
This study assesses the effectiveness of JoyRise Recovery Powder in reducing alcohol aftereffects, cognitive impairment, and anxiousness among participants aged 35-54 who consume alcohol. Participants will be randomly assigned to either the JoyRise group or a placebo group. The study will measure hangover symptoms, cognitive function, and overall well-being through a series of questionnaires and cognitive tests at baseline, 30 minutes after product consumption, and 4 hours later.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 35-54, male or female
  • Regular alcohol consumption
  • Event planned within one month that involves alcohol consumption
  • Willingness to avoid new medications or supplements during the study period
  • Must confirm that they will not drive while under the influence of alcohol.

Exclusion Criteria:

  • Anyone not in good health.
  • Anyone who has any chronic health conditions such as oncological or psychiatric disorders.
  • Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.
  • Anyone who is pregnant, breastfeeding, or trying to conceive.
  • Anyone who cannot/ will not commit to the study protocol.
  • Anyone with a history of substance abuse.
  • Anyone who has undergone an invasive medical procedure in the six months prior to the study, or has a procedure planned during the study duration.
  • Anyone currently using any medications that may affect their response to alcohol or impact hangover symptoms, such as diuretics (water pills) or medication for hypertension.
  • History of severe reactions or sensitivity to alcohol.
  • Anyone currently taking glutathione.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JoyRise Recovery Powder
Participants in this arm will receive JoyRise Recovery Powder, a dietary supplement containing Dihydromyricetin (DHM) and other natural ingredients.
Dietary supplement: JoyRise Recovery Powder
JoyRise Recovery Powder is a dietary supplement that contains Dihydromyricetin (DHM) and other natural ingredients. It is designed to mitigate the aftereffects of alcohol consumption. Participants will mix one serving in 8-12 oz of water and consume it the morning after alcohol consumption.
Placebo Comparator: Placebo
Participants in this arm will receive a placebo solution that is visually and tastefully similar to the JoyRise Recovery Powder but contains no active ingredients.
Dietary supplement: Placebo
A placebo solution that is visually and tastefully similar to JoyRise Recovery Powder but contains no active ingredients. It will be mixed in 8-12 oz of water and consumed the morning after alcohol consumption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Symptoms Associated with Alcohol Aftereffects
Time Frame: Baseline and 30 minutes after product consumption on the day following alcohol consumption.
Measurement of the reduction in alcohol aftereffects using the Alcohol Hangover Questionnaire (AHQ). Participants will self-report their symptoms, such as headache, nausea, and tiredness.
Baseline and 30 minutes after product consumption on the day following alcohol consumption.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Cognitive Function
Time Frame: Baseline and 30 minutes after product consumption on the day following alcohol consumption.
Measurement of cognitive function using Double Trouble (which assesses selective attention and processing speed). Participants will complete this assessment to determine any changes in cognitive function.
Baseline and 30 minutes after product consumption on the day following alcohol consumption.
Improvement in Cognitive Function
Time Frame: Baseline and 30 minutes after product consumption on the day following alcohol consumption.
Measurement of cognitive function using two cognitive tests: Feature Match (which assesses focus and processing). Participants will complete this assessment to determine any changes in cognitive function.
Baseline and 30 minutes after product consumption on the day following alcohol consumption.
Reduction in Feelings of Anxiousness
Time Frame: Baseline and 30 minutes after product consumption on the day following alcohol consumption.
Measurement of reduction in feelings of anxiousness using self-reported questionnaires. Participants will rate their anxiety levels to determine if the product provides a calming effect.
Baseline and 30 minutes after product consumption on the day following alcohol consumption.
Increased User Satisfaction with Overall Well-being
Time Frame: Baseline and 4+ hours after product consumption on the day following alcohol consumption.
Measurement of user satisfaction with overall well-being through self-reported questionnaires. Participants will rate their satisfaction with their physical and mental state post-alcohol consumption.
Baseline and 4+ hours after product consumption on the day following alcohol consumption.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joyrise

Collaborators

Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20374

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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