Immunological Effect of Increasing Doses of Natural Peptide

Not Applicable

• Conditions: Pharmacokinetics
• Interventions: Dietary Supplement: 1 gram of a protein hydrolysate; Dietary Supplement: 2 grams of a protein hydrolysate; Dietary Supplement: 4 grams of a protein hydrolysate; Dietary Supplement: 8 grams of a protein hydrolysate

• Registration Number: NCT05176678
• Lead Sponsor: Natural Immune Systems Inc

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.

Study Timeline

• Study Start: 2021-11-04
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-12-30
• Study First Posted: 2022-01-04
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-09
• Primary Completion: 2022-11-04
• Study Completion: 2023-07-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Escalating dose of natural protein hydrolysate - sequence A	1 gram of a protein hydrolysate	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.
Escalating dose of natural protein hydrolysate - sequence A	4 grams of a protein hydrolysate	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.
Escalating dose of natural protein hydrolysate - sequence B	1 gram of a protein hydrolysate	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.
Escalating dose of natural protein hydrolysate - sequence B	2 grams of a protein hydrolysate	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.
Escalating dose of natural protein hydrolysate - sequence B	8 grams of a protein hydrolysate	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.
Escalating dose of natural protein hydrolysate - sequence A	2 grams of a protein hydrolysate	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.

Primary Outcome Measures

Name	Time	Method
Changes to ex vivo PHA-mediated Th-17 cytokine secretion	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of lymphocytes	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.

Trial Locations

Locations (1)

Gitte Jensen; 🇺🇸 Klamath Falls, Oregon, United States