NCT06575972

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

August 23, 2024

Last Update Submit

August 26, 2024

Conditions

Keywords

Cognitive FunctionHangoverAnxiety Reduction

Outcome Measures

Primary Outcomes (1)

  • Reduction in Symptoms Associated with Alcohol Aftereffects

    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 Outcomes (4)

  • Improvement in Cognitive Function

    Baseline and 30 minutes after product consumption on the day following alcohol consumption.

  • Improvement in Cognitive Function

    Baseline and 30 minutes after product consumption on the day following alcohol consumption.

  • Reduction in Feelings of Anxiousness

    Baseline and 30 minutes after product consumption on the day following alcohol consumption.

  • Increased User Satisfaction with Overall Well-being

    Baseline and 4+ hours after product consumption on the day following alcohol consumption.

Study Arms (2)

JoyRise Recovery Powder

EXPERIMENTAL

Participants in this arm will receive JoyRise Recovery Powder, a dietary supplement containing Dihydromyricetin (DHM) and other natural ingredients.

Dietary Supplement: JoyRise Recovery Powder

Placebo

PLACEBO COMPARATOR

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

Interventions

JoyRise Recovery PowderDIETARY_SUPPLEMENT

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.

JoyRise Recovery Powder
PlaceboDIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

Age35 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Anxiety DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Mental DisordersCognition DisordersNeurocognitive Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
This study uses a double-blind design, meaning that both the participants and the investigators are unaware of the group assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy of JoyRise Recovery Powder in mitigating the aftereffects of alcohol consumption. The study involves two groups: one receiving the active supplement (JoyRise Recovery Powder) and the other receiving a placebo.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 28, 2024

Study Start

June 25, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations