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

August 24, 2023 updated by: Vitamin Energy®

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ability to concentration. [Baseline to Day 30]
Time Frame: 30 days
Survey-based assessment (0-5 scale) of participant reported concentration abilities.
30 days
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.
30 days
Changes in mood. [Baseline to Day 30]
Time Frame: 30 days
Survey-based assessment (0-5 scale) of mood.
30 days
Changes in brain fog. [Baseline to Day 30]
Time Frame: 30 days
Survey-based assessment (0-5 scale) of brain fog experienced by participants.
30 days
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitamin Energy®

Collaborators

Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2023

Primary Completion (Actual)

July 20, 2023

Study Completion (Actual)

July 20, 2023

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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