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

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.

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.

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.