NCT05176678

Immunological Effect of Increasing Doses of Natural Peptide

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Natural Immune Systems Inc · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-11-04
• Primary completion: 2022-11-04
• Completion: 2023-07-11
• First posted: 2022-01-04
• Last updated: 2022-06-09

Locations

1 site across 1 country: United States