EnergyNCT06019858
A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels
A study testing Vitamin Energy Shot in people with Energy and Fatigue, run by Vitamin Energy® at 1 site in United States.
Trial summary
This is a virtual, single-arm clinical trial that will last 30 days. Participants will drink 1 bottle of the Vitamin Energy® shot daily and complete questionnaires at baseline, Day 7, Day 14, and Day 30. Participants' energy, mood, and cognitive function will be evaluated at baseline and at each check-in. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Vitamin Energy Shot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2023to 20 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 18 years and over
- Self-reported issues with:
- Energy
- Focus
- Brain fog Participants who often feel fatigued Willing to maintain the same caffeine consumption during the study period Generally healthy - don't live with any uncontrolled chronic disease
Who cannot join
- 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 30 days. Participants will drink 1 bottle of the Vitamin Energy® shot daily and complete questionnaires at baseline, Day 7, Day 14, and Day 30.
Participants' energy, mood, and cognitive function will be evaluated at baseline and at each check-in. Bodyweight will also be assessed at baseline and Day 30. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores.
- Conditions
- Energy, Fatigue, Mood, Weight Loss, Cognition
- Being tested
- Vitamin Energy Shot
- Medical subject headings
- Fatigue, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin Energy ShotOther
Vitamin Energy® shot is a naturally-caffeinated functional energy shot that contains:
Vitamin B3 Vitamin B6 Vitamin B12 Natural Caffeine (green tea extract) L-Carnitine Tartrate Potassium Sorbate Taurine Sucralose
| Study group | Role | What they receive |
|---|---|---|
| Vitamin Energy Shot | Experimental | Participants will take one bottle daily of the Vitamin Energy® shot, in the morning. Receives: Other: Vitamin Energy Shot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in energy levels. [Baseline to Day 30]
Survey-based assessment (0-5 scale) of participant reported energy levels.
Measured: 30 days
Secondary outcomes (5)
Change in ability to concentration. [Baseline to Day 30]
Survey-based assessment (0-5 scale) of participant reported concentration abilities.
Measured: 30 days
Change in participant-perceived productivity. [Baseline to Day 30]
Survey-based assessment (0-5 scale) of participants perception of their productivity during the day.
Measured: 30 days
Changes in mood. [Baseline to Day 30]
Survey-based assessment (0-5 scale) of mood.
Measured: 30 days
Changes in brain fog. [Baseline to Day 30]
Survey-based assessment (0-5 scale) of brain fog experienced by participants.
Measured: 30 days
Change in body weight. [Baseline to Day 30]
Participants will weight themselves at baseline and endline and provide their body weight.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start21 Jun 2023
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnergyStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitamin Energy®
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019858
- Sponsor's protocol ID
- 20348
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 31 Aug 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 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels
- ClinicalTrials.gov ID
- NCT06019858
- Acronym / sponsor ID
- 20348
- Conditions
- Energy, Fatigue, Mood, Weight Loss, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vitamin Energy®Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 31 Aug 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 30 days. Participants will drink 1 bottle of the Vitamin Energy® shot daily and complete questionnaires at baseline, Day 7, Day 14, and Day 30.
Participants' energy, mood, and cognitive function will be evaluated at baseline and at each check-in. Bodyweight will also be assessed at baseline and Day 30. 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 |
|---|---|---|
| Vitamin Energy Shot | Experimental | Other: Vitamin Energy ShotParticipants will take one bottle daily of the Vitamin Energy® shot, in the morning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women 18 years and over
- Energy
- Focus
- Brain fog Participants who often feel fatigued Willing to maintain the same caffeine consumption during the study period Generally healthy - don't live with any uncontrolled chronic disease
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Vitamin Energy ShotVitamin Energy® shot is a naturally-caffeinated functional energy shot that contains: Vitamin B3 Vitamin B6 Vitamin B12 Natural Caffeine (green tea extract) L-Carnitine Tartrate Potassium Sorbate Taurine Sucralose | Other | Vitamin Energy Shot |
Primary outcome
Change in energy levels. [Baseline to Day 30]
Time frame: 30 days
Survey-based assessment (0-5 scale) of participant reported energy levels.
5 secondary outcomes
Change in ability to concentration. [Baseline to Day 30]
Time frame: 30 days
Change in participant-perceived productivity. [Baseline to Day 30]
Time frame: 30 days
Changes in mood. [Baseline to Day 30]
Time frame: 30 days
Changes in brain fog. [Baseline to Day 30]
Time frame: 30 days
Change in body weight. [Baseline to Day 30]
Time frame: 30 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 31 Aug 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 Vitamin Energy Shot in people with Energy and Fatigue, run by Vitamin Energy® 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 2 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 31 Aug 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 energy levels. [Baseline to Day 30] (time frame: 30 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 31 Aug 2023.