NCT05176678

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 4, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2023

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

November 4, 2021

Last Update Submit

June 7, 2022

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluation of lymphocytes

    2 weeks, 4 weeks, 6 weeks

Study Arms (2)

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.

Dietary Supplement: 1 gram of a protein hydrolysateDietary Supplement: 2 grams of a protein hydrolysateDietary Supplement: 4 grams of a protein hydrolysate

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.

Dietary Supplement: 1 gram of a protein hydrolysateDietary Supplement: 2 grams of a protein hydrolysateDietary Supplement: 8 grams of a protein hydrolysate

Interventions

1 gram of a protein hydrolysateDIETARY_SUPPLEMENT

After 1 gram of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.

Escalating dose of natural protein hydrolysate - sequence AEscalating dose of natural protein hydrolysate - sequence B
2 grams of a protein hydrolysateDIETARY_SUPPLEMENT

After 2 grams of a protein hydrolysate is taken daily for 2 weeks, 1 blood draw will be taken.

Escalating dose of natural protein hydrolysate - sequence AEscalating dose of natural protein hydrolysate - sequence B
4 grams of a protein hydrolysateDIETARY_SUPPLEMENT

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 A
8 grams of a protein hydrolysateDIETARY_SUPPLEMENT

After 8 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

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gitte Jensen

Klamath Falls, Oregon, 97601, United States

RECRUITING

Study Officials

  • Gitte S Jensen

    NIS Labs

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gitte S Jensen, PhD

CONTACT

541-884-0112gitte@nislabs.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

November 4, 2021

First Posted

January 4, 2022

Study Start

November 4, 2021

Primary Completion

November 4, 2022

Study Completion

July 11, 2023

Last Updated

June 9, 2022

Record last verified: 2022-06

Locations

US(1)