Exercise EnduranceNCT06300060
Synbiotic Supplementation in Cyclists
A study testing Synbiotic in people with Exercise Endurance, run by University of Calgary at 1 site in Canada.
Trial summary
The goal of this clinical trial is to assess the efficacy of a synbiotic blend on exercise performance and other exercise parameters in trained adult cyclists. It is hypothesized that those taking the synbiotic blend will have improved endurance exercise performance. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Endurance
- What is being tested?
- Synbiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2024to 23 Dec 2024
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between the ages of 18-45
- Currently cycling for at least 3 hours per week for the past 3 months
- Free of any contraindications to exercise and any medical condition that could interfere with or influence metabolic or cardiovascular responses to exercise
- Have a resting heart rate <100 bpm and resting systolic and diastolic blood pressures <160 mmHg and <90 mmHg, respectively.
Who cannot join
- Use of antibiotics or probiotic products within 4 weeks prior to study enrollment (note: participants will be eligible after a 2-week washout period)
- Current laxative use
- Are a smoker or use tobacco products
- Consume >21 units of alcohol per week
- Have donated blood in the previous 3 months
- Have a BMI ≥30kg/m2
Show all 13Show fewer
- Are pregnant or lactating or planning to become pregnant for the duration of the study
- Are dieting for weight loss or are following a low carbohydrate diet
- Have participated in another clinical trial within the 30 days preceding study enrollment
- Are taking medications known to affect cardiovascular or metabolic responses to exercise
- Have a medical condition that could interfere with study intervention and assessment
- Have current musculoskeletal injuries that limit exercise capacity
- Are non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Synbiotic Formulation on Endurance Exercise Performance in Trained Cyclists: A Randomized, Double-Blinded, Placebo-Controlled, Parallel Trial
The goal of this clinical trial is to assess the efficacy of a synbiotic blend on exercise performance and other exercise parameters in trained adult cyclists. It is hypothesized that those taking the synbiotic blend will have improved endurance exercise performance.
The primary objective is to assess the impact of a synbiotic on 20km distance trial performance in 36 cyclists. Secondary objectives include assessing the impact of the synbiotic on exercise metabolism, body composition, gastrointestinal and immune health.
Read the detailed description
The goal of this randomized double-blinded clinical trial is to evaluate the potential beneficial effects of a synbiotic formulation on exercise performance in trained adult cyclists. The main questions it aims to answer are related to the Synbiotic effects on:
- Cycling performance
- Exercise metabolism
- Gastrointestinal health
- Immune system
- Body composition
- Fecal Short Chain Fatty Acids (SCFAs)
- Fecal microbiome composition
Participants will be recruited and, if consenting and eligible, will undergo the initial pre-testing phase for baseline assessment (4 on-site visits). Then, they will be randomized to receive the synbiotic or placebo and instructed to consume one sachet daily for 42 consecutive days. After 4-5 weeks of intervention (Day 33), post-testing phase will start, and participants will be asked to return to the site to perform post testing assessments (over 4 on-site visits). Study visits will occur as follows, V1 (Day -9), V2 (Day -6), V3 (Day -3), V4 (Day 0), V5 (Day 33), V6 (Day 36), V7 (Day 39), and V8 (Day 42).
Researchers will compare the assessed outcomes to baseline in each group and evaluate the difference between groups following the synbiotic consumption to highlight any statistically and clinically relevant observations.
- Conditions
- Exercise Endurance
- Being tested
- Synbiotic, Placebo
- Keywords
- Exercise, Cyclists, Athlete, Synbiotic, Prebiotic, Probiotic, Gut microbiota, Metabolism
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
Combination of a probiotic and prebiotic. Daily administration in a single dose in powder form.
PlaceboDietary supplement
Placebo. Daily administration in a single dose in powder form.
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic | Experimental | Participants receive the synbiotic for 6 weeks. Receives: Dietary Supplement: Synbiotic |
| Placebo | Placebo comparator | Participants receive the placebo for 6 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endurance exercise performance measured during a 20km cycling distance trial
Assessed as time (minutes) to complete 20km cycling distance
Measured: 42 Days
Secondary outcomes (14)
Change in maximal oxygen consumption (V̇O2max) measured during a Step-Ramp-Step Test
Assessed as mL·kg-1·min-1 measured through expired air collection
Measured: 36 Days
Change in peak power output (PPO) measured during a Step-Ramp-Step Test
Assessed as highest power output in Watts
Measured: 36 Days
Change in power output corresponding to the gas exchange threshold (GET) and respiratory compensation point (RCP)
Assessed as power output in Watts at GET and RCP
Measured: 36 Days
Change in time to exhaustion measured during a cycling session at 85% of the peak power output
Assessed as time (minutes) to reach volitional exhaustion.
Measured: 39 Days
Change in fat and carbohydrate oxidation measured during exercise sessions
Assessed with the nonprotein respiratory quotient equation using expired air variables (VO2 and VCO2)
Measured: 36, 39 and 42 Days
Change in blood lactate concentration measured via pinprick capillary blood test
Assessed as mmol/L in capillary blood
Measured: 36, 39 and 42 Days
Change in body composition measured by dual energy X-ray absorptiometry (DXA)
Assessed as percent fat and muscle mass (%) with a DXA scan
Measured: 33 Days
Change in intestinal permeability markers measured in serum
Assessed in serum as pg/ml (Zonulin, Irisin, and Claudin2)
Measured: 33 Days
Change in cytokines
Assessed in serum as fg/ml (IFN-γ, IL-10, IL-12p70, IL-17, IL-1β, IL-2, IL-4, IL-6, TNF-α)
Measured: 33 Days
Change in gastrointestinal symptoms measured by self-report
Assessed via subjective ratings on a Patient-Reported Outcomes Measurement Information System® (PROMIS®)-GI scale
Measured: 33 Days
Change in fecal SCFA concentration measured by gas chromatography
Assessed as µmol/L of fecal SCFAs (acetate, butyrate, propionate, and total SCFAs)
Measured: 33 Days
Synbiotic strains quantification measured by qPCR in fecal matter
Assessed as 16S rRNA gene copies determined with qPCR
Measured: 33 Days from Day 0
Change in fecal microbiota composition
Assessed as relative abundance of the 16S rRNA amplicon obtained via sequencing
Measured: 33 Days
Incidence of adverse events
Assessed as the number of adverse events and serious adverse events reported
Measured: 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start15 Jul 2024
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise EnduranceStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel arm. Single-site, double-blinded, placebo-controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Principal investigator, Dr. Raylene Reimer, University of Calgary
- Investigators
- Raylene A Reimer, PhD, RD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300060
- Sponsor's protocol ID
- REB23-1161
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Synbiotic Formulation on Endurance Exercise Performance in Trained Cyclists: A Randomized, Double-Blinded, Placebo-Controlled, Parallel Trial
- ClinicalTrials.gov ID
- NCT06300060
- Acronym / sponsor ID
- REB23-1161
- Conditions
- Exercise Endurance
- Keywords
- Exercise, Cyclists, Athlete, Synbiotic, Prebiotic, Probiotic, Gut microbiota, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Lallemand Health Solutions
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 8 Mar 2024 (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.
The goal of this clinical trial is to assess the efficacy of a synbiotic blend on exercise performance and other exercise parameters in trained adult cyclists. It is hypothesized that those taking the synbiotic blend will have improved endurance exercise performance.
The primary objective is to assess the impact of a synbiotic on 20km distance trial performance in 36 cyclists. Secondary objectives include assessing the impact of the synbiotic on exercise metabolism, body composition, gastrointestinal and immune health.
Detailed description
The goal of this randomized double-blinded clinical trial is to evaluate the potential beneficial effects of a synbiotic formulation on exercise performance in trained adult cyclists. The main questions it aims to answer are related to the Synbiotic effects on:
- Cycling performance
- Exercise metabolism
- Gastrointestinal health
- Immune system
- Body composition
- Fecal Short Chain Fatty Acids (SCFAs)
- Fecal microbiome composition
Participants will be recruited and, if consenting and eligible, will undergo the initial pre-testing phase for baseline assessment (4 on-site visits). Then, they will be randomized to receive the synbiotic or placebo and instructed to consume one sachet daily for 42 consecutive days. After 4-5 weeks of intervention (Day 33), post-testing phase will start, and participants will be asked to return to the site to perform post testing assessments (over 4 on-site visits). Study visits will occur as follows, V1 (Day -9), V2 (Day -6), V3 (Day -3), V4 (Day 0), V5 (Day 33), V6 (Day 36), V7 (Day 39), and V8 (Day 42).
Researchers will compare the assessed outcomes to baseline in each group and evaluate the difference between groups following the synbiotic consumption to highlight any statistically and clinically relevant observations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel arm. Single-site, double-blinded, placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Synbiotic | Experimental | Dietary Supplement: SynbioticParticipants receive the synbiotic for 6 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants receive the placebo for 6 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female between the ages of 18-45
- Currently cycling for at least 3 hours per week for the past 3 months
- Free of any contraindications to exercise and any medical condition that could interfere with or influence metabolic or cardiovascular responses to exercise
- Have a resting heart rate <100 bpm and resting systolic and diastolic blood pressures <160 mmHg and <90 mmHg, respectively.
Key exclusion criteria (13 listed)
- Use of antibiotics or probiotic products within 4 weeks prior to study enrollment (note: participants will be eligible after a 2-week washout period)
- Current laxative use
- Are a smoker or use tobacco products
- Consume >21 units of alcohol per week
- Have donated blood in the previous 3 months
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 |
|---|---|---|
| SynbioticCombination of a probiotic and prebiotic. Daily administration in a single dose in powder form. | Dietary supplement | Synbiotic |
| PlaceboPlacebo. Daily administration in a single dose in powder form. | Dietary supplement | Placebo |
Primary outcome
Change in endurance exercise performance measured during a 20km cycling distance trial
Time frame: 42 Days
Assessed as time (minutes) to complete 20km cycling distance
14 secondary outcomes
Change in maximal oxygen consumption (V̇O2max) measured during a Step-Ramp-Step Test
Time frame: 36 Days
Change in peak power output (PPO) measured during a Step-Ramp-Step Test
Time frame: 36 Days
Change in power output corresponding to the gas exchange threshold (GET) and respiratory compensation point (RCP)
Time frame: 36 Days
Change in time to exhaustion measured during a cycling session at 85% of the peak power output
Time frame: 39 Days
Change in fat and carbohydrate oxidation measured during exercise sessions
Time frame: 36, 39 and 42 Days
Change in blood lactate concentration measured via pinprick capillary blood test
Time frame: 36, 39 and 42 Days
Change in body composition measured by dual energy X-ray absorptiometry (DXA)
Time frame: 33 Days
Change in intestinal permeability markers measured in serum
Time frame: 33 Days
Change in cytokines
Time frame: 33 Days
Change in gastrointestinal symptoms measured by self-report
Time frame: 33 Days
Change in fecal SCFA concentration measured by gas chromatography
Time frame: 33 Days
Synbiotic strains quantification measured by qPCR in fecal matter
Time frame: 33 Days from Day 0
Change in fecal microbiota composition
Time frame: 33 Days
Incidence of adverse events
Time frame: 42 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 1 May 2026.
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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.
Raylene A Reimer, PhD, RD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic in people with Exercise Endurance, run by University of Calgary 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 4 inclusion and 13 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 1 May 2026. 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?
Change in endurance exercise performance measured during a 20km cycling distance trial (time frame: 42 Days). 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 1 May 2026.