Immunological Effect of Increasing Doses of Natural Peptide

June 7, 2022 updated by: Gitte Jensen, Ph.D., Natural Immune Systems Inc

Clinical Proof-of-concept Study on Immunological Effects of Consuming Increasing Doses of a Natural Peptide in Healthy Volunteers

A trial monitoring the immune effects in 24 people with 4 different doses (1 gram per day, 2 grams per day, 4 grams per day, 8 grams per day) of a natural plant-based protein hydrolysate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal for this clinical proof-of-concept study is to compare immune effects of a novel plant-based peptide on IL-17, Th17 and related immunological mechanisms.

An open-label, escalating dose study design monitoring immune effects in which healthy men and women take doses of a natural protein hydrolysate daily for 6 weeks.

During the first 2 weeks, participants will consume 1 gram/day. For the next 2 weeks, participants will consume 2 grams/day. For the final 2 weeks, participants will be randomly assigned to consume either 4 grams/day or 8 grams/day.

Blood samples are collected at baseline and every 2 weeks. The blood will be used for testing of the numbers of T lymphocytes that secrete Interleukin-17 after ex vivo cell cultures.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Oregon
      • Klamath Falls, Oregon, United States, 97601
        • Recruiting
        • Gitte Jensen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 24 men and women
  • Eating a typical diet that does not exceed an estimated average of 9 grams of salt per day;
  • Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements;
  • Willing to comply with study procedures including: Maintaining a consistent diet and lifestyle routine throughout the study, Consistent habit of bland breakfasts on days of clinic visits, Abstaining from exercising and nutritional supplements on the morning of a study visit, Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit; Abstaining from music, candy, gum, computer/cell phone use, during clinic visits.

Exclusion Criteria:

  • Previous major gastrointestinal surgery Vaccination during past month;
  • Vaccination planned during study;
  • Cancer during past 12 months;
  • Chemotherapy during past 12 months;
  • Diagnosed with an autoimmune disorder;
  • Diagnosed with obstructive sleep apnea syndrome (OSAS);
  • Currently taking medication containing Levodopa (L-dopa);
  • Having received a cortisone shot within the past 6 months;
  • Taking anti-inflammatory medications on a daily basis;
  • Currently experiencing intense stressful events/life changes;
  • Currently in intensive athletic training (such as marathon runners);
  • An unusual sleep routine
  • Changes to nutritional supplements during the past month;
  • Currently taking Vitamin D at a dose higher than 1,000 IU/day;
  • Currently taking omega-3 at a dose higher than 1 gram/day;
  • Unwilling to maintain a constant intake of supplements over the duration of the study;
  • Women of childbearing potential: Pregnant, nursing, or trying to become pregnant;
  • Known food intolerances related to ingredients in active test product.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Escalating dose of natural protein hydrolysate - sequence A
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.
Dietary supplement: 1 gram of a protein hydrolysate
After 1 gram of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
Dietary supplement: 2 grams of a protein hydrolysate
After 2 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
Dietary supplement: 4 grams of a protein hydrolysate
After 4 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
ACTIVE_COMPARATOR: Escalating dose of natural protein hydrolysate - sequence B
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.
Dietary supplement: 1 gram of a protein hydrolysate
After 1 gram of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
Dietary supplement: 2 grams of a protein hydrolysate
After 2 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
Dietary supplement: 8 grams of a protein hydrolysate
After 8 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes to ex vivo PHA-mediated Th-17 cytokine secretion
Time Frame: 2 weeks, 4 weeks, 6 weeks
Ex vivo PBMC cultures with the mitogen PHA, followed by testing of cytokine production using a Th-17 Luminex array.
2 weeks, 4 weeks, 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of lymphocytes
Time Frame: 2 weeks, 4 weeks, 6 weeks
Ex vivo PBMC cultures with the mitogen PHA, followed by flow cytometry evaluation of T-cell differentiation and intracellular staining for Interleukin-17.
2 weeks, 4 weeks, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natural Immune Systems Inc

Investigators

  • Principal Investigator: Gitte S Jensen, NIS Labs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 4, 2021

Primary Completion (ANTICIPATED)

November 4, 2022

Study Completion (ANTICIPATED)

July 11, 2023

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

December 30, 2021

First Posted (ACTUAL)

January 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • NIS 184-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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