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Protein Hydrolysate

Escalating dose of natural protein hydrolysate - sequence B for Pharmacokinetics

N/A

Recruiting

Led By Gitte S Jensen

Research Sponsored by Natural Immune Systems Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks, 4 weeks, 6 weeks

Awards & highlights

Study Summary

This trial is testing the effects of different doses of a protein on the immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks, 4 weeks, 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks, 4 weeks, 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 4 weeks, 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes to ex vivo PHA-mediated Th-17 cytokine secretion

Secondary outcome measures

Evaluation of lymphocytes

Trial Design

2Treatment groups

Active Control

Group I: Escalating dose of natural protein hydrolysate - sequence BActive Control3 Interventions

Participants will consume escalating doses of natural protein hydrolysate: Week 1-2: 1 gram/day, Week 3-4: 2 gram/day, Week 5-6: 8 gram/day.

Group II: Escalating dose of natural protein hydrolysate - sequence AActive Control3 Interventions

Participants will consume escalating doses of natural protein hydrolysate: Week 1-2: 1 gram/day, Week 3-4: 2 gram/day, Week 5-6: 4 gram/day.

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Who is running the clinical trial?

Natural Immune Systems IncLead Sponsor

18 Previous Clinical Trials

463 Total Patients Enrolled

2 Trials studying Pharmacokinetics

48 Patients Enrolled for Pharmacokinetics

Gitte S JensenPrincipal InvestigatorNIS Labs

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors included in the scope of this research study?

"The minimum entry age for this medical research is 25 years old and the maxiumum allowed is 65."

Answered by AI

How many participants have enrolled in this clinical experiment?

"Affirmative. Clinicaltrials.gov documents that this medical experiment, first posted on November 4th 2021, is currently recruiting participants. 24 subjects need to be recruited from 1 trial site."

Answered by AI

Are the criteria for this experiment compatible with my profile?

"To meet the qualifying criteria for this clinical trial, participants need to have pharmacokinetics and should be between 25-65 years old. This investigation is hoping to enrol around 24 people in total."

Answered by AI

Has recruitment for this clinical trial been initiated?

"Confirmed, the information posted on clinicaltrials.gov states that this experiment is still recruiting patients. The trail was first initiated on November 4th 2021 and has since been updated last June 7th 2022. 24 participants are needed across a single medical site in order to complete the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Immunological Effect of Increasing Doses of Natural Peptide

Gitte Jensen, Ph.D. 2021. "Immunological Effect of Increasing Doses of Natural Peptide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05176678.