Back to resultsAn Exploratory Investigation of a B12 Vitamin to Increase Energy and Focus
Primary Purpose
B12 Deficiency Vitamin, Energy Supply; Deficiency, Mood
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hype Bites Supplement
Sponsored by
About this trial
This is an interventional other trial for B12 Deficiency Vitamin focused on measuring Vitamin Deficiency, Energy, Mood-states, focus
Eligibility Criteria
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
Sites / Locations
- Citruslabs
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hype Bites Supplement
Arm Description
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
Outcomes
Primary Outcome Measures
Examine if Hype Bites increase vitamin B12 in the blood
In order to examine the changes in B12, a blood sample will be used.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05517005
First Posted
August 24, 2022
Last Updated
August 24, 2022
Sponsor
Sourse
Collaborators
Citruslabs
1. Study Identification
Unique Protocol Identification Number
NCT05517005
Brief Title
An Exploratory Investigation of a B12 Vitamin to Increase Energy and Focus
Official Title
An Exploratory Investigation of a B12 Vitamin to Increase Energy and Focus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 22, 2022 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sourse
Collaborators
Citruslabs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B12 Deficiency Vitamin, Energy Supply; Deficiency, Mood
Keywords
Vitamin Deficiency, Energy, Mood-states, focus
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hype Bites Supplement
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Hype Bites Supplement
Intervention Description
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
Primary Outcome Measure Information:
Title
Examine if Hype Bites increase vitamin B12 in the blood
Description
In order to examine the changes in B12, a blood sample will be used.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
examine the subjective improvements noticed by the study participants when supplementing with vitamin B12.
Description
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
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Hill, PhD
Organizational Affiliation
Citruslabs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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An Exploratory Investigation of a B12 Vitamin to Increase Energy and Focus
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