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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escalating dose of natural protein hydrolysate - sequence A | Active Comparator | 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. |
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| Escalating dose of natural protein hydrolysate - sequence B | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 gram of a protein hydrolysate | Dietary Supplement | After 1 gram of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gitte S Jensen, PhD | Contact | 541-884-0112 | gitte@nislabs.com |
| Name | Affiliation | Role |
|---|---|---|
| Gitte S Jensen | NIS Labs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gitte Jensen | Recruiting | Klamath Falls | Oregon | 97601 | United States |
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| 2 grams of a protein hydrolysate | Dietary Supplement | After 2 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken. |
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| 4 grams of a protein hydrolysate | Dietary Supplement | After 4 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken. |
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| 8 grams of a protein hydrolysate | Dietary Supplement | After 8 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken. |
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