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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Joyrise

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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