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Status unknownNCT05176678Updated Jun 9, 2022

Immunological Effect of Increasing Doses of Natural Peptide

An interventional study of 1 gram of a protein hydrolysate and 2 grams of a protein hydrolysate in Pharmacokinetics, sponsored by Natural Immune Systems Inc. Status unknown at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-09.

Sponsored by Natural Immune Systems Inc · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pharmacokinetics
03

In context

Lead sponsor

Natural Immune Systems Inc is the lead sponsor of 25 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • 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 · Dietary Supplement: 2 grams of a protein hydrolysate · Dietary Supplement: 4 grams of a protein hydrolysate

  • 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 · Dietary Supplement: 2 grams of a protein hydrolysate · Dietary Supplement: 8 grams of a protein hydrolysate

Interventions

  • Dietary supplement1 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 supplement2 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 supplement4 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 supplement8 grams of a protein hydrolysate

    After 8 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 weeks, 4 weeks, 6 weeks

Secondary outcomes

  1. 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.

    Time frame: 2 weeks, 4 weeks, 6 weeks

07

Study locations

1 of 1 sites recruiting
  • Gitte Jensen
    Klamath Falls, Oregon 97601, United States
    • Gitte S Jensen, PhD · Contact · gitte@nislabs.com · 541-884-0112
    • GItte S Jensen, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05176678
Lead sponsor
Natural Immune Systems Inc
Responsible party
Gitte Jensen, Ph.D. (Research Director, Natural Immune Systems Inc) — Principal investigator
First posted
Jan 4, 2022
Start date
Nov 4, 2021
Primary completion
Nov 4, 2022 (estimated)
Completion
Jul 11, 2023 (estimated)
Last update
Jun 9, 2022

Study contacts

Gitte S Jensen, PhD
Contact
gitte@nislabs.com
541-884-0112
Gitte S Jensen
principal investigator · NIS Labs

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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