53 Day

Daily MyVitalC for hsCRP Reduction and Improved Sleep Study

STUDY TITLE Daily MyVitalC for hsCRP Reduction and Improved Sleep Study
Submitted under umbrella

Minimal Risk Citizen Science Umbrella Protocol

Date submitted

-

End date

There is no pre-specified end date and sub-studies remain open long-term.

Language

English

Efforia AI IRB approval recommendation

Recruitment page preview

Preview

Author edit

Edit

Informed consent

Review

Study author

Chris Burres

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

This study will explore the impact of daily intake of MyVitalC ESS60 in Olive Oil (5 ml per day) on reducing elevated high-sensitivity C-reactive protein (hsCRP) levels. Participants will begin with 5 days of baseline surveys followed by 48 days of supplementation and data collection. A second bottle of the product will be sent on day 10 if compliance is met, and an at-home test kit will be provided on day 35 to retest hsCRP levels.

Participant engagement length

53 Days

Sponsor

This study is made possible by your payment to cover all supplies and expenses required to participate.

Cost to participant

$0

Included products & services
Inflammation Blood Test: $137
Ferritin and Iron at Home Blood Test: $105
Outcome measures

PROMIS Sleep Disturbance Scale

Fatigue Perception and Impact Survey

Depression, Anxiety and Stress Scales (DASS-21) Survey

Iron and Ferritin Blood Levels

Methodology

Single Arm longitudinal where participants act as their own control

Basic or advanced dissemination plan

Basic

Deviation from recruitment approach

No

Deviation from statistical approach

No

Will study include “more about you questions”

No

Clinicaltrials.Gov

Yes

Committment to list findings on clinicaltrials.Gov

Yes

This document is prepared with the assistance of AI, but is reviewed by a human.

Rational & Study Design

The Intervention

Included Products & Services

Product Name: Inflammation Blood Test

Quantity included: 1

Price: $137.00

Product Description: Efforia, in partnership with Tasso, introduces the "Inflammation" test, featuring Cortisol and hsCRP measurements. Our easy-to-use, shoulder-attached device gently collects a minimal blood sample non-invasively. Though a bit pricier, it's much more comfortable than conventional methods, ideal for those wary of needles. Just mail it back in the enclosed pre-paid envelope for analysis. Convenient, efficient, and pain-free.

Product Image:

Ingredients:

Product Safety:

Product Name: Ferritin and Iron at Home Blood Test

Quantity included: 1

Price: $105.00

Product Description: Easily check your iron and ferritin levels at home with the MyLabsDirect test kit, featuring the Tasso specimen collection device. Simply clean your upper arm, apply the Tasso device, and press a button to painlessly collect a small blood sample in minutes. Secure your sample in the provided tube, package it, and mail it to MyLabsDirect’s CLIA-certified lab for accurate results-no clinic visit required

Product Image:

Ingredients:

Product Safety:

Study Design & Methodology

Inappropriate Participants & Inclusion/Exclusion

Study Design & Experience

Statistical Analysis Plan

Limitations & Justification

Human Subjects Ethics

Suitability Under Minimal Risk Umbrella Protocol

Suitability for Pay to Participate Model

Human Subjects Protection Questionnaire