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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05517005
Other study ID # 20248
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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