Immunological Effect of Increasing Doses of Natural Peptide
NCT ID: NCT05176678
Last Updated: 2022-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2021-11-04
2023-07-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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Escalating dose of natural protein hydrolysate - sequence A
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.
1 gram of a protein hydrolysate
After 1 gram of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
2 grams of a protein hydrolysate
After 2 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
4 grams of a protein hydrolysate
After 4 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
Escalating dose of natural protein hydrolysate - sequence B
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.
1 gram of a protein hydrolysate
After 1 gram of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
2 grams of a protein hydrolysate
After 2 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
8 grams of a protein hydrolysate
After 8 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
Interventions
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1 gram of a protein hydrolysate
After 1 gram of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
2 grams of a protein hydrolysate
After 2 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
4 grams of a protein hydrolysate
After 4 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
8 grams of a protein hydrolysate
After 8 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
65 Years
ALL
Yes
Sponsors
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Natural Immune Systems Inc
OTHER
Responsible Party
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Gitte Jensen, Ph.D.
Research Director
Principal Investigators
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Gitte S Jensen
Role: PRINCIPAL_INVESTIGATOR
NIS Labs
Locations
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Gitte Jensen
Klamath Falls, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NIS 184-001
Identifier Type: -
Identifier Source: org_study_id
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