21 Participants Needed

Extended Release Protein for Nutrition

CS
Overseen ByChief Strategy Officer

What You Need to Know Before You Apply

What is the purpose of this trial?

The overall goal of this study is to determine the minimum dose required to elicit measurable elevation of plasma essential amino acid levels 12 hours after consuming VitaKey's extended release protein technology. The results of this study will be used to set a dose for future protein clinical studies.

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 18-40 with a BMI of 20-28. Participants must not use tobacco or nicotine, agree to follow study rules, sign consent forms, and have good vein access for blood draws. They can't have health issues that would interfere with the study.

Inclusion Criteria

I am between 18 and 40 years old.
My BMI is between 20 and 28.
I haven't used tobacco or nicotine products in the last year and don't plan to start.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different doses of VitaKey's extended release protein technology to determine the minimum dose required for measurable elevation of plasma essential amino acid levels

12 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Extended Release Nutritional Protein

Trial Overview

The study tests VitaKey's extended release protein to find the smallest dose that raises essential amino acid levels in the blood after 12 hours. It compares this new protein form against a control group and different dosages.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Negative Dose Extended Release ProteinExperimental Treatment1 Intervention
Group II: Low Dose Extended Release ProteinExperimental Treatment1 Intervention
Group III: High Dose Extended Release ProteinExperimental Treatment1 Intervention
Group IV: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VitaKey Inc.

Lead Sponsor

United States Department of Defense (DOD)

Collaborator

Trials
1
Recruited
42,500+