NCT03518281

Brief Summary

Upper respiratory tract infections cause cold and flu-like symptoms and are the most common form of acute illness. Certain populations are at increased risk of upper respiratory tract infections including athletes who train at a high level of intensity for prolonged periods of time. Consequently, some athletes experience higher rates of cold and flu-like symptoms than the general population. Euglena gracilis is a micro-algae which can synthesize many nutrients necessary for human health, including insoluble beta glucan. Thus, intake of whole cell Euglena may be beneficial to athletes by providing essential vitamins to optimize immune function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 31, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 28, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 5, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

January 31, 2018

Last Update Submit

December 4, 2018

Conditions

Symptoms FluSymptoms Cold

Outcome Measures

Primary Outcomes (1)

  • Incidence of upper respiratory tract infections

    incidence of very mild/mild/ moderate/ severe upper respiratory tract infection symptoms

    ANOVA of 90 day supplementation

Secondary Outcomes (5)

  • Symptom Duration

    30 and 90 days

  • Stress

    90 days

  • Secretory IgA

    90 days

  • Natural Killer (NK) Cell Population

    90 days

  • Gastrointestinal status

    30 and 90 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Treatment

EXPERIMENTAL

Whole Cell Euglena delivering βeta Glucan

Dietary Supplement: Whole Cell Euglena containing Beta Glucan

Interventions

Whole Cell Euglena containing Beta GlucanDIETARY_SUPPLEMENT

Whole Cell Euglena containing \>50% Beta Glucan

Treatment
PlaceboDIETARY_SUPPLEMENT

microcrystalline cellulose, hypromellose, titanium dioxide, water

Placebo

Eligibility Criteria

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

You may qualify if:

  • Body Mass Index (BMI) \> 18 kg/m2 to \<35 kg/m2.
  • Willing to comply with a wash-out period for nutritional supplements known to affect immune function and to not consume these supplements for the entire study period
  • Females of childbearing potential must agree to use a medically approved method of birth control
  • Agree to maintaining a consistent diet and lifestyle routine throughout the study
  • An endurance training athlete
  • Healthy as determined by laboratory results and medical history

You may not qualify if:

  • Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
  • Verbal confirmation of previous major gastrointestinal surgery
  • Consuming doses of beta-glucan-containing nutritional supplements
  • Chronic consumption of anti-inflammatory medications
  • Taking antibiotics within 4 weeks of screening and during the study period
  • Verbal confirmation of a diagnosed chronic inflammatory condition or autoimmune disorder
  • Verbal confirmation of Type I or Type II diabetes or clinically important renal, hepatic, cardiac, pulmonary, pancreatic, neurologic, or biliary disorder, or a recent history (prior 2 years) of cancer other than non-melanoma skin cancer
  • Currently taking antipsychotic medications
  • Chronic recurring respiratory signs and symptoms due to allergies (including seasonal allergies) or chronic bronchitis, asthma, or wheezing
  • Use of immunomodulators (including corticosteroids) such as immunosuppressant or immunostimulant medications within 4 weeks of baseline and during the study period
  • Chronic use of Antacids and Proton Pump Inhibitors (PPI)
  • Individuals who have received or are planning to receive the flu vaccination for the current flu season
  • Active infection or signs/symptoms of an acute infection
  • Heavy use of tobacco
  • Alcohol or drug abuse within the last 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All parties, except an outside person not involved in the study, will be blinded to the treatment conditions
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, Double-Blind, Placebo Controlled
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2018

First Posted

May 8, 2018

Study Start

March 28, 2018

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

December 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)