Alcohol AftereffectsNCT06575972
A Clinical Study to Assess the Effects of JoyRise Recovery Powder on Mitigating Alcohol Aftereffects.
A study testing JoyRise Recovery Powder in people with Alcohol Aftereffects and Anxiety, run by Joyrise at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Aftereffects, Anxiety, Cognitive Impairment
- What is being tested?
- JoyRise Recovery Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alcohol Aftereffects, Anxiety, Cognitive Impairment
- Being tested
- JoyRise Recovery Powder, Placebo
- Keywords
- Cognitive Function, Hangover, Anxiety Reduction
- Medical subject headings
- Anxiety Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| JoyRise Recovery Powder | Experimental | Participants in this arm will receive JoyRise Recovery Powder, a dietary supplement containing Dihydromyricetin (DHM) and other natural ingredients. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 30 minutes after product consumption on the day following alcohol consumption.
Secondary outcomes (4)
Improvement in Cognitive Function
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.
Measured: Baseline and 30 minutes after product consumption on the day following alcohol consumption.
Improvement in Cognitive Function
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.
Measured: Baseline and 30 minutes after product consumption on the day following alcohol consumption.
Reduction in Feelings of Anxiousness
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.
Measured: Baseline and 30 minutes after product consumption on the day following alcohol consumption.
Increased User Satisfaction with Overall Well-being
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.
Measured: Baseline and 4+ hours after product consumption on the day following alcohol consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start25 Jun 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AftereffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joyrise
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575972
- Sponsor's protocol ID
- 20374
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess the Effects of JoyRise Recovery Powder on Mitigating Alcohol Aftereffects.
- ClinicalTrials.gov ID
- NCT06575972
- Acronym / sponsor ID
- 20374
- Conditions
- Alcohol Aftereffects, Anxiety, Cognitive Impairment
- Keywords
- Cognitive Function, Hangover, Anxiety Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- JoyriseIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| JoyRise Recovery Powder | Experimental | Dietary Supplement: JoyRise Recovery PowderParticipants in this arm will receive JoyRise Recovery Powder, a dietary supplement containing Dihydromyricetin (DHM) and other natural ingredients. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants in this arm will receive a placebo solution that is visually and tastefully similar to the JoyRise Recovery Powder but contains no active ingredients. |
Who may qualify
- Ages
- 35 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JoyRise Recovery PowderJoyRise 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. | Dietary supplement | JoyRise Recovery Powder |
| PlaceboA 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. | Dietary supplement | Placebo |
Primary outcome
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.
4 secondary outcomes
Improvement in Cognitive Function
Time frame: 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.
Reduction in Feelings of Anxiousness
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JoyRise Recovery Powder in people with Alcohol Aftereffects and Anxiety, run by Joyrise at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Symptoms Associated with Alcohol Aftereffects (time frame: Baseline and 30 minutes after product consumption on the day following alcohol consumption.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.