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

Mood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05517005
• Other study ID #: 20248
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 22, 2022
• Est. completion date: September 2022

Study information

• Verified date: August 2022
• Source: Sourse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Avitaminosis
• B12 Deficiency Vitamin
• Energy Supply; Deficiency
• Mood
• Vitamin A Deficiency
• Vitamin B 12 Deficiency

Intervention

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

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Sourse	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine if Hype Bites increase vitamin B12 in the blood	In order to examine the changes in B12, a blood sample will be used.	8 weeks
Secondary	examine the subjective improvements noticed by the study participants when supplementing with vitamin B12.	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