Clinical Proof-of-concept Study on Immune Surveillance and Alertness

NCT05431751 | Unknown

• 1 other identifier: 153-012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical proof-of-concept study comparing the acute. effects of an algae-based dietary supplement on immune surveillance and alertness. This study involves twenty-four participants composed of healthy adults, who will be taking either a placebo or supplement at different times. Testing for immune status, cytokine levels, and immune responsiveness will be conducted to determine the acute impact of the supplement on immune function compared to a placebo. Long term effects and lingering effects will be tested using the same parameters, following a consumption period of one week, as well as a washout period of one week.

Conditions

Immune Surveillance

Outcome Measures

Primary Outcomes (1)

• Immune Surveillance and Alerness

  Observation of changes in immune cell trafficking and status of immune cell alertness, ie. the changes in immune cell populations and activation following administration.

  2 hours, 1 week

Secondary Outcomes (1)

• Immune communication

  2 hours, 1 week

Other Outcomes (1)

• Immune Responsiveness

  2 hours, 1 week

Study Arms (1)

Experimental Group A

EXPERIMENTAL

Crossover study: Participants will be consuming placebo on a clinic day at least 1 week prior to a clinic day where they will consume the active intervention. Following the second clinic day, the participant will consume active intervention for 7 days. The participant will then undergo a washout period of 7 days.

Dietary Supplement: Whole Algae

Interventions

Whole Algae DIETARY_SUPPLEMENT

Whole Euglena gracilis algae, produced by proprietary fermentation.

Experimental Group A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults
• Veins easy to see in both arms
• Willing to comply with a 24-hours 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, tobacco use, 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
• Willing to abstain from music, candy, gum, computer/cellphone use during clinic visits

You may not qualify if:

• Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder)
• Taking anti-inflammatory medications on a daily basis (81 mg aspirin is acceptable)
• Vaccination during past 2 weeks
• Currently experiencing intense stressful events/ life changes
• Currently in intensive athletic training (such as marathon runners)
• Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel
• An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights)
• Unwilling to maintain a constant intake of supplements over the duration of the study
• Anxiety about having blood drawn
• People of childbearing potential: Pregnant, nursing, or trying to become pregnant
• Known food allergies or sensitivities related to the test product or placebo
• Prescription medication will be evaluated on a case-by-case basis

Sponsors & Collaborators

• Natural Immune Systems Inc: lead

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo-controlled, cross-over study design

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: July 12, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 1, 2023
• Last Updated: August 7, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)