Pharmacokinetics
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENT1 gram of a protein hydrolysate
After 1 gram of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
DIETARY_SUPPLEMENT2 grams of a protein hydrolysate
After 2 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
DIETARY_SUPPLEMENT4 grams of a protein hydrolysate
After 4 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
DIETARY_SUPPLEMENT8 grams of a protein hydrolysate
After 8 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.
Sponsors
Natural Immune Systems Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes to ex vivo PHA-mediated Th-17 cytokine secretion | 2 weeks, 4 weeks, 6 weeks | Ex vivo PBMC cultures with the mitogen PHA, followed by testing of cytokine production using a Th-17 Luminex array. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of lymphocytes | 2 weeks, 4 weeks, 6 weeks | Ex vivo PBMC cultures with the mitogen PHA, followed by flow cytometry evaluation of T-cell differentiation and intracellular staining for Interleukin-17. |
Countries
United States
Contacts
Primary ContactGitte S Jensen, PhD
Outcome results
None listed