NCT05517005

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

August 24, 2022

Last Update Submit

August 21, 2024

Conditions

Keywords

Vitamin DeficiencyEnergyMood-statesfocus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • examine the subjective improvements noticed by the study participants when supplementing with vitamin B12.

    8 weeks

Study Arms (1)

Hype Bites Supplement

EXPERIMENTAL

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

Interventions

Hype Bites SupplementDIETARY_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

Hype Bites Supplement

Eligibility Criteria

Age24 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Vitamin B 12 DeficiencyAvitaminosis

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Christopher Hill, PhD

    Citruslabs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 26, 2022

Study Start

May 22, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

August 23, 2024

Record last verified: 2022-08

Locations