Back to resultsA Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels
Primary Purpose
Energy, Fatigue, Mood
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin Energy Shot
Sponsored by
About this trial
This is an interventional other trial for Energy
Eligibility 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.
Sites / Locations
- Citruslabs
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vitamin Energy Shot
Arm Description
Participants will take one bottle daily of the Vitamin Energy® shot, in the morning.
Outcomes
Primary Outcome Measures
Change in energy levels. [Baseline to Day 30]
Survey-based assessment (0-5 scale) of participant reported energy levels.
Secondary Outcome Measures
Change in ability to concentration. [Baseline to Day 30]
Survey-based assessment (0-5 scale) of participant reported concentration abilities.
Change in participant-perceived productivity. [Baseline to Day 30]
Survey-based assessment (0-5 scale) of participants perception of their productivity during the day.
Changes in mood. [Baseline to Day 30]
Survey-based assessment (0-5 scale) of mood.
Changes in brain fog. [Baseline to Day 30]
Survey-based assessment (0-5 scale) of brain fog experienced by participants.
Change in body weight. [Baseline to Day 30]
Participants will weight themselves at baseline and endline and provide their body weight.
Full Information
NCT ID
NCT06019858
First Posted
August 24, 2023
Last Updated
August 24, 2023
Sponsor
Vitamin Energy®
Collaborators
Citruslabs
1. Study Identification
Unique Protocol Identification Number
NCT06019858
Brief Title
A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels
Official Title
A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
July 20, 2023 (Actual)
Study Completion Date
July 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitamin Energy®
Collaborators
Citruslabs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Energy, Fatigue, Mood, Weight Loss, Cognition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin Energy Shot
Arm Type
Experimental
Arm Description
Participants will take one bottle daily of the Vitamin Energy® shot, in the morning.
Intervention Type
Other
Intervention Name(s)
Vitamin Energy Shot
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in energy levels. [Baseline to Day 30]
Description
Survey-based assessment (0-5 scale) of participant reported energy levels.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Change in ability to concentration. [Baseline to Day 30]
Description
Survey-based assessment (0-5 scale) of participant reported concentration abilities.
Time Frame
30 days
Title
Change in participant-perceived productivity. [Baseline to Day 30]
Description
Survey-based assessment (0-5 scale) of participants perception of their productivity during the day.
Time Frame
30 days
Title
Changes in mood. [Baseline to Day 30]
Description
Survey-based assessment (0-5 scale) of mood.
Time Frame
30 days
Title
Changes in brain fog. [Baseline to Day 30]
Description
Survey-based assessment (0-5 scale) of brain fog experienced by participants.
Time Frame
30 days
Title
Change in body weight. [Baseline to Day 30]
Description
Participants will weight themselves at baseline and endline and provide their body weight.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels
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