Immunological Effect of Increasing Doses of Natural Peptide

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176678
• Other study ID #: NIS 184-001
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2021
• Est. completion date: July 11, 2023

Study information

• Verified date: June 2022
• Source: Natural Immune Systems Inc
• Contact: Gitte S Jensen, PhD
• Phone: 541-884-0112
• Email: gitte[@]nislabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 11, 2023
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Gitte Jensen	Klamath Falls	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Natural Immune Systems Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes to ex vivo PHA-mediated Th-17 cytokine secretion	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	Evaluation of lymphocytes	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