An Exploratory Investigation of a B12 Vitamin to Increase Energy and Focus

August 21, 2024 updated by: Sourse
This study aims to examine the effects of Sourse's Hype Bites at being able to increase vitamin B12 levels to promote positive health outcomes. Participants will consume Hype Bites daily. Participants will also take surveys and blood samples to examine both the subjective experience of taking Hype Bites as well as changes in biomarkers across the trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

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

24 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI < 40 On a stable, consistent dietary regimen Must be on a vegan or vegetarian diet May experience the feeling of being tired often/several times a week. May experience brain fog May experience negative mood states

Exclusion Criteria:

  • Females who are pregnant or breastfeeding Currently take vitamin B12 during the past four weeks Chronic conditions such has oncological of psychiatric disorders Anyone with IBS or IBD Anyone with a previous severe allergic reaction Anyone 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: Hype Bites Supplement
Participants will take the 2 chocolates each day, complete surveys at baseline, midpoint, and study conclusion, and take blood biomarker samples at baseline and conclusion
Dietary supplement: Hype Bites Supplement

The ingredients of the vitamin supplement are:

Chocolate liquor Sugar Cocoa butter Vanilla extract Vitamin B12 (as methylcobalamin) Tapioca Gum arabic Coloring (radish, apple, black currant) Carnauba Wax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine if Hype Bites increase vitamin B12 in the blood
Time Frame: 8 weeks
In order to examine the changes in B12, a blood sample will be used.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
examine the subjective improvements noticed by the study participants when supplementing with vitamin B12.
Time Frame: 8 weeks
Questionnaires will be given to participants throughout the trial. These questionnaires will ask about changes in their ability to focus, concentrate, their energy levels, and their mood
8 weeks

Collaborators and Investigators

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

Sponsor

Sourse

Collaborators

Citruslabs

Investigators

  • Principal Investigator: Christopher Hill, PhD, 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)

May 22, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20248

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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