Immunological Effect of Increasing Doses of Natural Peptide

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Proof-of-concept Study on Immunological Effects of Consuming Increasing Doses of a Natural Peptide in Healthy Volunteers

Conditions
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Pharmacokinetics

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Escalating dose of natural protein hydrolysate - sequence A<br>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<br>* After 1 gram of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.<br>Dietary Supplement: 2 grams of a protein hydrolysate<br>* After 2 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.<br>Dietary Supplement: 4 grams of a protein hydrolysate<br>* After 4 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.<br>|
| Active Comparator: Escalating dose of natural protein hydrolysate - sequence B<br>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<br>* After 1 gram of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.<br>Dietary Supplement: 2 grams of a protein hydrolysate<br>* After 2 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.<br>Dietary Supplement: 8 grams of a protein hydrolysate<br>* After 8 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks, 4 weeks, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks, 4 weeks, 6 weeks |