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| Name | Class |
|---|---|
| Lallemand Health Solutions | INDUSTRY |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic | Experimental | Participants receive the synbiotic for 6 weeks. |
|
| Placebo | Placebo Comparator | Participants receive the placebo for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synbiotic | Dietary Supplement | Combination of a probiotic and prebiotic. Daily administration in a single dose in powder form. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in endurance exercise performance measured during a 20km cycling distance trial | Assessed as time (minutes) to complete 20km cycling distance | 42 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 36 Days |
| Change in peak power output (PPO) measured during a Step-Ramp-Step Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raylene A Reimer, PhD, RD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D058616 | Synbiotics |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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Parallel arm. Single-site, double-blinded, placebo-controlled trial.
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The synbiotic and placebo are both powders identical in taste and appearance and are equally dissolvable in cold water.
| Placebo | Dietary Supplement | Placebo. Daily administration in a single dose in powder form. |
|
Assessed as highest power output in Watts
| 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 | 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. | 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) | 36, 39 and 42 Days |
| Change in blood lactate concentration measured via pinprick capillary blood test | Assessed as mmol/L in capillary blood | 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 | 33 Days |
| Change in intestinal permeability markers measured in serum | Assessed in serum as pg/ml (Zonulin, Irisin, and Claudin2) | 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) | 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 | 33 Days |
| Change in fecal SCFA concentration measured by gas chromatography | Assessed as µmol/L of fecal SCFAs (acetate, butyrate, propionate, and total SCFAs) | 33 Days |
| Synbiotic strains quantification measured by qPCR in fecal matter | Assessed as 16S rRNA gene copies determined with qPCR | 33 Days from Day 0 |
| Change in fecal microbiota composition | Assessed as relative abundance of the 16S rRNA amplicon obtained via sequencing | 33 Days |
| Incidence of adverse events | Assessed as the number of adverse events and serious adverse events reported | 42 Days |
| D010829 |
| Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |