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

Sponsor

Vitamin Energy® (Industry)

Overall Status

Completed

CT.gov ID

NCT06019858

Collaborator

Citruslabs (Industry)

Enrollment

Location

Arm

Actual Duration (Days)

31.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Energy Fatigue Mood Weight Loss Cognition	Other: Vitamin Energy Shot	N/A

Study Design

Study Type:

Interventional

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 :

Jun 21, 2023

Actual Primary Completion Date :

Jul 20, 2023

Actual Study Completion Date :

Jul 20, 2023

Arms and Interventions

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

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

Primary Outcome Measures

Change in energy levels. [Baseline to Day 30] [30 days]
Survey-based assessment (0-5 scale) of participant reported energy levels.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Citruslabs	Santa Monica	California	United States	90404

Sponsors and Collaborators

Vitamin Energy®
Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vitamin Energy®

ClinicalTrials.gov Identifier:

NCT06019858

Other Study ID Numbers:

20348

First Posted:

Aug 31, 2023

Last Update Posted:

Aug 31, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Weight Loss

Vitamins

Study Results

No Results Posted as of Aug 31, 2023