Clinical trial NCT05176678: Immunological Effect of Increasing Doses of Natural Peptide
Official title: Clinical Proof-of-concept Study on Immunological Effects of Consuming Increasing Doses of a Natural Peptide in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pharmacokinetics
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes to ex vivo PHA-mediated Th-17 cytokine secretion
timeFrame: 2 weeks, 4 weeks, 6 weeks
Secondary outcomes:
measure: Evaluation of lymphocytes
timeFrame: 2 weeks, 4 weeks, 6 weeks
Other outcomes:
Locations:
city: Klamath Falls
country: United States
facility: Gitte Jensen
state: Oregon
Study officials:
affiliation: NIS Labs
name: Gitte S Jensen
role: PRINCIPAL_INVESTIGATOR
References: