ADHDNCT05857956
A Clinical Trial to Assess the Efficacy of a Plant-based Energy Shot on Focus and ADHD-like Symptoms
A study testing Proper Wild energy shot in people with ADHD and Attention Difficulties, run by Proper Wild, Inc. at 1 site in United States.
Trial summary
This is a virtual, single-arm clinical trial that will last 28 days. Participants will drink 1 bottle of Proper Wild energy shot daily and complete questionnaires at baseline, day 1, day 14, and day 28. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Attention Difficulties, Mood
- What is being tested?
- Proper Wild energy shot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2023to 11 Apr 2023
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently experiencing symptoms associated with ADHD, including:
- Impulsiveness. Disorganization and problems prioritizing Poor time management skills Problems focusing on a task Trouble multitasking Excessive activity or restlessness Poor planning
- Age 18-55
- Self-reported issues with focus and/or productivity
- Generally healthy - don't live with any uncontrolled chronic disease
Who cannot join
- Currently taking prescription medication for ADHD
- Currently supplementing with L-Theanine.
- Known to respond negatively to caffeine (no effect, makes them sleepy or feel unwell)
- People with a high caffeine tolerance defined as regular consumption of >400mg of caffeine (>4 coffees) per day.
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Anyone with known severe allergic reactions.
- Women who are pregnant, breastfeeding, or attempting to become pregnant
- Unwilling to follow the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
This is a virtual, single-arm clinical trial that will last 28 days. Participants will drink 1 bottle of Proper Wild energy shot daily and complete questionnaires at baseline, day 1, day 14, and day 28.
Attention deficit hyperactivity disorder (ADHD)-like symptoms, such as concentration, focus, and attention, will be evaluated at baseline and at each check-in. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores.
- Conditions
- ADHD, Attention Difficulties, Mood, Anxiety, Caffeine
- Being tested
- Proper Wild energy shot
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proper Wild energy shotOther
100% plant-based energy shot containing natural caffeine, L-Theanine, purified water, pineapple juice concentrate, natural flavors, kiwi juice concentrate, organic lemon juice concentrate, organic strawberry juice concentrate, monk fruit juice concentrate, pink himalayan sea salt.
| Study group | Role | What they receive |
|---|---|---|
| Proper Wild energy shot | Experimental | Participants will take one bottle daily of Proper Wild Energy shot in the morning. Participants will be advised to drink one bottle in the morning, with or without a meal, depending on their preference, as a replacement for their usual first caffeinated beverage of the day. Receives: Other: Proper Wild energy shot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Attention-deficit/hyperactivity disorder (ADHD)-like symptoms. [Time Frame: Baseline to Day 28]
Survey-based assessment (0-5) scale of changes in symptoms associated with ADHD. Parameters explored include focus \& concentration, productivity, mood, and "brain fog".
Measured: 28 days
Secondary outcomes (1)
Assess the product as a replacement for coffee or caffeinated beverages. [Time Frame: Baseline to Day 28]
Survey-based assessment regarding changes in daily coffee/beverage consumption, stress, anxiety, jitters, energy crash, and gastrointestinal upset. Responses will be statistically analyzed and reported as % of subject responses.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start24 Feb 2023
- Primary completion7 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proper Wild, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857956
- Sponsor's protocol ID
- 20290
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess the Efficacy of a Plant-based Energy Shot on Focus and ADHD-like Symptoms
- ClinicalTrials.gov ID
- NCT05857956
- Acronym / sponsor ID
- 20290
- Conditions
- ADHD, Attention Difficulties, Mood, Anxiety, Caffeine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Proper Wild, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 15 May 2023 (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 is a virtual, single-arm clinical trial that will last 28 days. Participants will drink 1 bottle of Proper Wild energy shot daily and complete questionnaires at baseline, day 1, day 14, and day 28.
Attention deficit hyperactivity disorder (ADHD)-like symptoms, such as concentration, focus, and attention, will be evaluated at baseline and at each check-in. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proper Wild energy shot | Experimental | Other: Proper Wild energy shotParticipants will take one bottle daily of Proper Wild Energy shot in the morning. Participants will be advised to drink one bottle in the morning, with or without a meal, depending on their preference, as a replacement for their usual first caffeinated beverage of the day. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Currently experiencing symptoms associated with ADHD, including:
- Impulsiveness. Disorganization and problems prioritizing Poor time management skills Problems focusing on a task Trouble multitasking Excessive activity or restlessness Poor planning
- Age 18-55
- Self-reported issues with focus and/or productivity
- Generally healthy - don't live with any uncontrolled chronic disease
Key exclusion criteria (8 listed)
- Currently taking prescription medication for ADHD
- Currently supplementing with L-Theanine.
- Known to respond negatively to caffeine (no effect, makes them sleepy or feel unwell)
- People with a high caffeine tolerance defined as regular consumption of >400mg of caffeine (>4 coffees) per day.
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
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 |
|---|---|---|
| Proper Wild energy shot100% plant-based energy shot containing natural caffeine, L-Theanine, purified water, pineapple juice concentrate, natural flavors, kiwi juice concentrate, organic lemon juice concentrate, organic strawberry juice concentrate, monk fruit juice concentrate, pink himalayan sea salt. | Other | Proper Wild energy shot |
Primary outcome
Change in Attention-deficit/hyperactivity disorder (ADHD)-like symptoms. [Time Frame: Baseline to Day 28]
Time frame: 28 days
Survey-based assessment (0-5) scale of changes in symptoms associated with ADHD. Parameters explored include focus \& concentration, productivity, mood, and "brain fog".
1 secondary outcome
Assess the product as a replacement for coffee or caffeinated beverages. [Time Frame: Baseline to Day 28]
Time frame: 28 days
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 15 May 2023.
- Individual participant dataSharing planned: Undecided
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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 Proper Wild energy shot in people with ADHD and Attention Difficulties, run by Proper Wild, Inc. 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 8 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 15 May 2023. 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. 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?
Change in Attention-deficit/hyperactivity disorder (ADHD)-like symptoms. [Time Frame: Baseline to Day 28] (time frame: 28 days). 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 15 May 2023.