Escalating dose of natural protein hydrolysate - sequence A for Pharmacokinetics

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pharmacokinetics1 gram of a protein hydrolysate - DietarySupplement
Eligibility
25 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the effects of different doses of a protein on the immune system.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 2 weeks, 4 weeks, 6 weeks

Week 6
Changes to ex vivo PHA-mediated Th-17 cytokine secretion
Evaluation of lymphocytes

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Escalating dose of natural protein hydrolysate - sequence A
1 of 2
Escalating dose of natural protein hydrolysate - sequence B
1 of 2

Active Control

24 Total Participants · 2 Treatment Groups

Primary Treatment: Escalating dose of natural protein hydrolysate - sequence A · No Placebo Group · N/A

Escalating dose of natural protein hydrolysate - sequence AActiveComparator Group · 3 Interventions: 1 gram of a protein hydrolysate, 4 grams of a protein hydrolysate, 2 grams of a protein hydrolysate · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement
Escalating dose of natural protein hydrolysate - sequence BActiveComparator Group · 3 Interventions: 1 gram of a protein hydrolysate, 2 grams of a protein hydrolysate, 8 grams of a protein hydrolysate · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks, 4 weeks, 6 weeks

Who is running the clinical trial?

Natural Immune Systems IncLead Sponsor
16 Previous Clinical Trials
409 Total Patients Enrolled
2 Trials studying Pharmacokinetics
48 Patients Enrolled for Pharmacokinetics
Gitte S JensenPrincipal InvestigatorNIS Labs

Eligibility Criteria

Age 25 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements.
You do not exceed an estimated average of 9 grams of salt per day.