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A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06019858
Recruitment Status : Completed
First Posted : August 31, 2023
Last Update Posted : August 31, 2023
Sponsor:
Collaborator:
Citruslabs
Information provided by (Responsible Party):
Vitamin Energy®

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Energy Fatigue Mood Weight Loss Cognition Other: Vitamin Energy Shot Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels
Actual Study Start Date : June 21, 2023
Actual Primary Completion Date : July 20, 2023
Actual Study Completion Date : July 20, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Vitamin Energy Shot
Participants will take one bottle daily of the Vitamin Energy® shot, in the morning.
 Other: Vitamin Energy Shot

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


Outcome Measures
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Primary Outcome Measures :
  1. Change in energy levels. [Baseline to Day 30] [ Time Frame: 30 days ]
    Survey-based assessment (0-5 scale) of participant reported energy levels.


Secondary Outcome Measures :
  1. Change in ability to concentration. [Baseline to Day 30] [ Time Frame: 30 days ]
    Survey-based assessment (0-5 scale) of participant reported concentration abilities.

  2. Change in participant-perceived productivity. [Baseline to Day 30] [ Time Frame: 30 days ]
    Survey-based assessment (0-5 scale) of participants perception of their productivity during the day.

  3. Changes in mood. [Baseline to Day 30] [ Time Frame: 30 days ]
    Survey-based assessment (0-5 scale) of mood.

  4. Changes in brain fog. [Baseline to Day 30] [ Time Frame: 30 days ]
    Survey-based assessment (0-5 scale) of brain fog experienced by participants.

  5. Change in body weight. [Baseline to Day 30] [ Time Frame: 30 days ]
    Participants will weight themselves at baseline and endline and provide their body weight.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06019858


Locations
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United States, California
Citruslabs
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Vitamin Energy®
Citruslabs
More Information
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Responsible Party: Vitamin Energy®
ClinicalTrials.gov Identifier: NCT06019858    
Other Study ID Numbers: 20348
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: August 31, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
 Vitamins
Micronutrients
Physiological Effects of Drugs