Immunological Effect of Increasing Doses of Natural Peptide

Natural Immune Systems

Status: Enrolling

Conditions: Pharmacokinetics

Treatments: Dietary Supplement: 4 grams of a protein hydrolysate; Dietary Supplement: 2 grams of a protein hydrolysate; Dietary Supplement: 1 gram of a protein hydrolysate; Dietary Supplement: 8 grams of a protein hydrolysate

Study type: Interventional

Funder types: Other

Identifiers

NCT05176678

NIS 184-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Escalating dose of natural protein hydrolysate - sequence A

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: 4 grams of a protein hydrolysate

Dietary Supplement: 1 gram of a protein hydrolysate

Dietary Supplement: 2 grams of a protein hydrolysate

Escalating dose of natural protein hydrolysate - sequence B

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: 8 grams of a protein hydrolysate

Dietary Supplement: 1 gram of a protein hydrolysate

Dietary Supplement: 2 grams of a protein hydrolysate