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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06019858
• Other study ID #: 20348
• Status: Completed
• Phase: N/A
• Start date: June 21, 2023
• Est. completion date: July 20, 2023

Study information

• Verified date: August 2023
• Source: Vitamin Energy®
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 20, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognition
• Energy
• Fatigue
• Mood
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Vitamin Energy®	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in energy levels. [Baseline to Day 30]	Survey-based assessment (0-5 scale) of participant reported energy levels.	30 days
Secondary	Change in ability to concentration. [Baseline to Day 30]	Survey-based assessment (0-5 scale) of participant reported concentration abilities.	30 days
Secondary	Change in participant-perceived productivity. [Baseline to Day 30]	Survey-based assessment (0-5 scale) of participants perception of their productivity during the day.	30 days
Secondary	Changes in mood. [Baseline to Day 30]	Survey-based assessment (0-5 scale) of mood.	30 days
Secondary	Changes in brain fog. [Baseline to Day 30]	Survey-based assessment (0-5 scale) of brain fog experienced by participants.	30 days
Secondary	Change in body weight. [Baseline to Day 30]	Participants will weight themselves at baseline and endline and provide their body weight.	30 days