ColdNCT03769012
Ability of Beta-glucan Supplementation to Augment Immune Function
A study testing Beta-Glucan in people with Cold and Cold Symptom, run by Kemin Foods LC at 1 site in Canada.
Trial summary
This proposed study is designed to assess the efficacy of a capsule containing beta-glucan taken orally daily as compared to a placebo capsule on the URTI symptoms, and the immune response change in marathon runners Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cold, Cold Symptom, Flu
- What is being tested?
- Beta-Glucan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 27 Dec 2018to 30 May 2020
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and Females 21-65 years age
- Body Mass Index (BMI) > 18 kg/m2 to < 34.99 kg/m2
- Willing to wash-out for nutritional supplements known to affect immune function
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- Agree to keep lifestyle habits consistent
- Currently registered to participate in a full marathon and on a training regimen
- Healthy as determined by laboratory results, medical history, and physical exam
- Has given voluntary, written, informed consent to participate in the study
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the occurrence of the trial
- Verbal confirmation of previous major gastrointestinal surgery or other major digestive disorder which may interfere with the absorption of nutrients
- Participant has a known allergy to the test material's active or inactive ingredients
- Chronic consumption of beta-glucan supplements
- Consumption of anti-inflammatory medications known to affect immune function
- On antibiotics within 4 weeks of baseline
Show all 14Show fewer
- Currently taking antipsychotic medications
- Prebiotics and probiotics unless on a stable regimen
- Verbal confirmation of Type I or Type II diabetes or clinically important renal, hepatic, cardiac, pulmonary, pancreatic, neurologic, or biliary disorder, or cancer to be assessed by QI
- Verbal confirmation of a diagnosed chronic inflammatory condition
- Verbal confirmation of autoimmune disease or if immune-compromised
- Chronic recurring respiratory signs and symptoms due to allergies (including seasonal allergies) or chronic bronchitis, asthma, or wheezing
- Current or history (within past 6 months) of tobacco use
- Consumption of >14 standard alcoholic drinks per week
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 Beta-glucan (to Augment Immune Function, Decrease URTI Incidence Rates, and Counter Immune Changes in Marathon Runners
This proposed study is designed to assess the efficacy of a capsule containing beta-glucan taken orally daily as compared to a placebo capsule on the URTI symptoms, and the immune response change in marathon runners
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 will 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. Each volunteer will be sequentially assigned a screening number to be entered in the screening and enrollment log. Screening assessments include: review medical history, assess inclusion and exclusion criteria, vitals, study diary, URTI symptom questionnaire, bowel diary, and GI symptom questionnaire.
The next visit will be scheduled 14 days prior to their marathon date (baseline). Participants will be reminded to complete URTI questionnaire, daily study diary, modified GI symptoms and bowel diary in advance of this baseline visit. At baseline participants will begin daily completion of study diaries, URTI questionnaires, daily bowel diaries, and GI tolerance questionnaires. In clinic subjects will complete mood and stress questionnaires, and blood sample for the analysis of CRP and NK cell activity. In addition, on the day of the marathon the participant will be instructed to complete a muscle soreness assessment.
Two and four weeks post-marathon participants will return to the clinic for with unused investigational product, completed study diaries, daily URTI questionnaires, daily bowel diaries, and GI tolerance questionnaires. In clinic subjects will complete mood and stress questionnaires, and blood sample for the analysis of CRP and NK cell activity.
- Conditions
- Cold, Cold Symptom, Flu, Flu Symptom, Supplement, Stress
- Being tested
- Beta-Glucan, Placebo
- Medical subject headings
- Common Cold, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-GlucanDietary supplement
95% beta-glucan sourced from whole cell Euglena Gracilis
PlaceboDietary supplement
microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Beta-Glucan Receives: Dietary Supplement: Beta-Glucan |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Cold/Flu Symptom Severity Score Wisconsin Upper Respiratory Symptom Survey (WURSS)
AUC for cold/flu symptoms from Wisconsin Upper Respiratory Symptom Score
Measured: ANOVA with 2 and 4 weeks post-marathon
Secondary outcomes (9)
URTI Cold/Flu Symptoms from Wisconsin Upper Respiratory Symptom Survey
Total number of symptoms
Measured: ANOVA with 2 and 4 weeks post-marathon
Severity of cold/flu symptoms from Wisconsin Upper Respiratory Symptom Survey
Total severity score (each symptom scored on scale of 0-no symptom to 7-severe symptom)
Measured: ANOVA with 2 and 4 weeks post-marathon
URTI Episodes from Wisconsin Upper Respiratory Symptom Survey
Total number of URTI Episodes/person
Measured: ANOVA with 2 and 4 weeks post-marathon
Sick days
Total number of sick days/person
Measured: ANOVA with 2 and 4 weeks post-marathon
Sick days
Percentage of subjects with sick days
Measured: ANOVA with 2 and 4 weeks post-marathon
Stress Level from the perceived stress scale
Change from baseline on the Perceived Stress Scale
Measured: ANOVA with 2 and 4 weeks post-marathon
C-Reactive Protein
Change in concentration from baseline
Measured: ANOVA with 2 and 4 weeks post-marathon
Natural Killer Cell Activity
Change from baseline
Measured: ANOVA with 2 and 4 weeks post-marathon
Gastrointestinal symptoms
Total gastrointestinal symptom rating score (GSRS)
Measured: ANOVA with 2 and 4 weeks post-marathon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start27 Dec 2018
- Primary completion30 Nov 2019
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColdStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, double-blind, placebo-controlled, parallel study
- 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
- NCT03769012
- Sponsor's protocol ID
- 19BIHK
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2018
- Last updated
- 3 Feb 2021
- 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 3 Feb 2021. 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 Beta-glucan (to Augment Immune Function, Decrease URTI Incidence Rates, and Counter Immune Changes in Marathon Runners
- ClinicalTrials.gov ID
- NCT03769012
- Acronym / sponsor ID
- 19BIHK
- Conditions
- Cold, Cold Symptom, Flu, Flu Symptom, Supplement, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kemin Foods LCIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 7 Dec 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.
This proposed study is designed to assess the efficacy of a capsule containing beta-glucan taken orally daily as compared to a placebo capsule on the URTI symptoms, and the immune response change in marathon runners
Detailed description
At screening, an informed consent form will be given to the potential volunteer. They will be required to read the information and will 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. Each volunteer will be sequentially assigned a screening number to be entered in the screening and enrollment log. Screening assessments include: review medical history, assess inclusion and exclusion criteria, vitals, study diary, URTI symptom questionnaire, bowel diary, and GI symptom questionnaire.
The next visit will be scheduled 14 days prior to their marathon date (baseline). Participants will be reminded to complete URTI questionnaire, daily study diary, modified GI symptoms and bowel diary in advance of this baseline visit. At baseline participants will begin daily completion of study diaries, URTI questionnaires, daily bowel diaries, and GI tolerance questionnaires. In clinic subjects will complete mood and stress questionnaires, and blood sample for the analysis of CRP and NK cell activity. In addition, on the day of the marathon the participant will be instructed to complete a muscle soreness assessment.
Two and four weeks post-marathon participants will return to the clinic for with unused investigational product, completed study diaries, daily URTI questionnaires, daily bowel diaries, and GI tolerance questionnaires. In clinic subjects will complete mood and stress questionnaires, and blood sample for the analysis of CRP and NK cell activity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, randomized, double-blind, placebo-controlled, parallel study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Beta-GlucanBeta-Glucan |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and Females 21-65 years age
- Body Mass Index (BMI) > 18 kg/m2 to < 34.99 kg/m2
- Willing to wash-out for nutritional supplements known to affect immune function
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- Agree to keep lifestyle habits consistent
Key exclusion criteria (14 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the occurrence of the trial
- Verbal confirmation of previous major gastrointestinal surgery or other major digestive disorder which may interfere with the absorption of nutrients
- Participant has a known allergy to the test material's active or inactive ingredients
- Chronic consumption of beta-glucan supplements
- Consumption of anti-inflammatory medications known to affect immune function
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 |
|---|---|---|
| Beta-Glucan95% beta-glucan sourced from whole cell Euglena Gracilis | Dietary supplement | Treatment |
| Placebomicrocrystalline cellulose | Dietary supplement | Placebo |
Primary outcome
Global Cold/Flu Symptom Severity Score Wisconsin Upper Respiratory Symptom Survey (WURSS)
Time frame: ANOVA with 2 and 4 weeks post-marathon
AUC for cold/flu symptoms from Wisconsin Upper Respiratory Symptom Score
9 secondary outcomes
URTI Cold/Flu Symptoms from Wisconsin Upper Respiratory Symptom Survey
Time frame: ANOVA with 2 and 4 weeks post-marathon
Severity of cold/flu symptoms from Wisconsin Upper Respiratory Symptom Survey
Time frame: ANOVA with 2 and 4 weeks post-marathon
URTI Episodes from Wisconsin Upper Respiratory Symptom Survey
Time frame: ANOVA with 2 and 4 weeks post-marathon
Sick days
Time frame: ANOVA with 2 and 4 weeks post-marathon
Sick days
Time frame: ANOVA with 2 and 4 weeks post-marathon
Stress Level from the perceived stress scale
Time frame: ANOVA with 2 and 4 weeks post-marathon
C-Reactive Protein
Time frame: ANOVA with 2 and 4 weeks post-marathon
Natural Killer Cell Activity
Time frame: ANOVA with 2 and 4 weeks post-marathon
Gastrointestinal symptoms
Time frame: ANOVA with 2 and 4 weeks post-marathon
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 3 Feb 2021.
- 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 Beta-Glucan in people with Cold and Cold Symptom, 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 8 inclusion and 14 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 3 Feb 2021. 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?
Global Cold/Flu Symptom Severity Score Wisconsin Upper Respiratory Symptom Survey (WURSS) (time frame: ANOVA with 2 and 4 weeks post-marathon). 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 3 Feb 2021.