Symptoms FluNCT03518281
Ability of a Euglena Beta Glucan Supplementation to Augment Immune Function
A study testing Whole Cell Euglena containing Beta Glucan in people with Symptoms Flu and Symptoms Cold, run by Kemin Foods LC at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptoms Flu, Symptoms Cold
- What is being tested?
- Whole Cell Euglena containing Beta Glucan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 28 Mar 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Ability of a Euglena Beta Glucan Supplementation to Augment Immune Function in Endurance Athletes
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.
Read the detailed description
At screening, an informed consent form will be given to the potential volunteer. They will be required to read the information and be given the opportunity to seek more information if needed, or provided with the option of taking the consent form home to review prior to making their decision. If agreeable, the volunteer will sign the consent form and receive a duplicate of the signed copy. Once consent has been obtained, the screening visit will proceed.
Screening assessments include:
- Review of medical history, concomitant therapies and current health status (weight, height, BMI, vital signs, safety blood work)
- Assesses inclusion and exclusion criteria
- Urine pregnancy test for female potential participants that are not post-menopausal
Eligible participants will return to the clinic for baseline assessments. Baseline (day 0) assessments include:
- Review of concomitant therapies and current health status
- Review pre-supplement emergent AEs
- Reassess inclusion and exclusion criteria
- Randomization of eligible participants
- Dispense daily upper respiratory tract symptom questionnaire
- Collect saliva sample for measurement of secretory IgA
- Collect blood sample for the analysis of cell activity
- Administer mood and stress questionnaire in-clinic
- Dispense daily gastrointestinal and bowel questionnaire
- Dispense investigational product and instruct participants on use
- Dispense daily study diary
At the end-of-study visit (Day 90) participants will return to the clinic for Visit 3 assessments with unused investigational product, completed study diaries, daily symptom questionnaires, daily gastrointestinal and bowel diaries.
Visit 3 assessments include:
- Collection of all study diaries
- Return of unused investigational product and calculate compliance
- Review of concomitant therapies and adverse events
- Check of health status (vitals, BMI, safety bloodwork)
- Administer mood and stress questionnaire in-clinic.
- Collect saliva sample for an end-of-study measurement of secretory IgA
- Complete Product Tolerability and Perception Questionnaire
- Conditions
- Symptoms Flu, Symptoms Cold
- Being tested
- Whole Cell Euglena containing Beta Glucan, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Cell Euglena containing Beta GlucanDietary supplement
Whole Cell Euglena containing >50% Beta Glucan
PlaceboDietary supplement
microcrystalline cellulose, hypromellose, titanium dioxide, water
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Treatment | Experimental | Whole Cell Euglena delivering βeta Glucan Receives: Dietary Supplement: Whole Cell Euglena containing Beta Glucan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of upper respiratory tract infections
incidence of very mild/mild/ moderate/ severe upper respiratory tract infection symptoms
Measured: ANOVA of 90 day supplementation
Secondary outcomes (5)
Symptom Duration
Duration of very mild/mild/moderate/sever upper respiratory tract infection symptoms
Measured: 30 and 90 days
Stress
Effect of treatment on Stress via Perceived Stress Scale Total Score
Measured: 90 days
Secretory IgA
Effect of treatment on secretory IgA levels
Measured: 90 days
Natural Killer (NK) Cell Population
Effect of treatment on NK cell population changes
Measured: 90 days
Gastrointestinal status
Effect of treatment on gastrointestinal status via questionnaire
Measured: 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start28 Mar 2018
- Primary completion1 Sep 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptoms FluStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kemin Foods LC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518281
- Sponsor's protocol ID
- 18ECHK-1
- Status last verified
- Jan 2018
- First submitted
- 31 Jan 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Ability of a Euglena Beta Glucan Supplementation to Augment Immune Function in Endurance Athletes
- ClinicalTrials.gov ID
- NCT03518281
- Acronym / sponsor ID
- 18ECHK-1
- Conditions
- Symptoms Flu, Symptoms Cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kemin Foods LCIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At screening, an informed consent form will be given to the potential volunteer. They will be required to read the information and be given the opportunity to seek more information if needed, or provided with the option of taking the consent form home to review prior to making their decision. If agreeable, the volunteer will sign the consent form and receive a duplicate of the signed copy. Once consent has been obtained, the screening visit will proceed.
Screening assessments include:
- Review of medical history, concomitant therapies and current health status (weight, height, BMI, vital signs, safety blood work)
- Assesses inclusion and exclusion criteria
- Urine pregnancy test for female potential participants that are not post-menopausal
Eligible participants will return to the clinic for baseline assessments. Baseline (day 0) assessments include:
- Review of concomitant therapies and current health status
- Review pre-supplement emergent AEs
- Reassess inclusion and exclusion criteria
- Randomization of eligible participants
- Dispense daily upper respiratory tract symptom questionnaire
- Collect saliva sample for measurement of secretory IgA
- Collect blood sample for the analysis of cell activity
- Administer mood and stress questionnaire in-clinic
- Dispense daily gastrointestinal and bowel questionnaire
- Dispense investigational product and instruct participants on use
- Dispense daily study diary
At the end-of-study visit (Day 90) participants will return to the clinic for Visit 3 assessments with unused investigational product, completed study diaries, daily symptom questionnaires, daily gastrointestinal and bowel diaries.
Visit 3 assessments include:
- Collection of all study diaries
- Return of unused investigational product and calculate compliance
- Review of concomitant therapies and adverse events
- Check of health status (vitals, BMI, safety bloodwork)
- Administer mood and stress questionnaire in-clinic.
- Collect saliva sample for an end-of-study measurement of secretory IgA
- Complete Product Tolerability and Perception Questionnaire
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo Controlled
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Treatment | Experimental | Dietary Supplement: Whole Cell Euglena containing Beta GlucanWhole Cell Euglena delivering βeta Glucan |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Cell Euglena containing Beta GlucanWhole Cell Euglena containing >50% Beta Glucan | Dietary supplement | Treatment |
| Placebomicrocrystalline cellulose, hypromellose, titanium dioxide, water | Dietary supplement | Placebo |
Primary outcome
Incidence of upper respiratory tract infections
Time frame: ANOVA of 90 day supplementation
incidence of very mild/mild/ moderate/ severe upper respiratory tract infection symptoms
5 secondary outcomes
Symptom Duration
Time frame: 30 and 90 days
Stress
Time frame: 90 days
Secretory IgA
Time frame: 90 days
Natural Killer (NK) Cell Population
Time frame: 90 days
Gastrointestinal status
Time frame: 30 and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Cell Euglena containing Beta Glucan in people with Symptoms Flu and Symptoms Cold, run by Kemin Foods LC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of upper respiratory tract infections (time frame: ANOVA of 90 day supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018; AzTrials last refreshed its copy on 26 Oct 2026.