The Effect of a Synbiotic Formulation on Endurance Exercise Performance in Trained Cyclists: A Randomized, Double-Blinded, Placebo-Controlled, Parallel Trial
Summary
This study will explore how a 6-week synbiotic (prebiotic + probiotic) intervention influences metabolic and physiological responses to exercise. As a participant, you will be required to visit the Human Performance Lab a total of 8 times (4 pre intervention and 4 post intervention) to perform a variety of exercise tests. In the first session, you will undergo a dual-energy x-ray absorptiometry (DXA) scan, have a venous blood sample collected, and fill out a variety of questionnaires. In the second visit you will perform a maximal effort exercise test to determine your aerobic fitness. In the third visit you will complete a 60 minute moderate intensity cycling test followed by a high intensity time to exhaustion test. In the fourth visit you will perform a 20km distance cycling trial.
After you have completed your 4 pre testing visits, you will be randomized to either the synbiotic or placebo group for 6 weeks and you will be instructed to consume one packet daily. You will not know which group you are in, neither will anyone on the study team. After approximately 4 weeks you will come back to the Human Performance Lab to perform the identical 4 testing sessions you performed during pre testing.
*Please note that you will be required to provide 2 blood samples and 2 stool samples during this study
Eligibility
Eligible ages: 18 to 45
Accepts healthy participants: Yes
Inclusion criteria:
To be eligible for this study you must meet all of the criteria below:
1. Male or female between the ages of 18-45
2. Currently cycling for at least 3 hours per week for the past 3 months
3. Free of any contraindications to exercise and any medical condition that could interfere with or influence exercise responses
4. Have a resting heart rate <100 bpm and resting systolic and diastolic blood pressures <160 mmHg and <90 mmHg, respectively
5. Willing to maintain the same exercise routine and eating habits for the duration of the study
6. Willing to discontinue consumption of probiotic supplements and probiotic fortified products throughout the study
Exclusion criteria:
You are not eligible for the study if you have one or more of the below conditions:
1. Have taken antibiotics in the 4 weeks weeks prior to study enrollment (this criterion can be revoked if you pass through a 2-week washout period from the final day of antibiotic use)
2. Have regularly used prebiotics, probiotics, or synbiotics in the 4 weeks prior to study enrollment (this criterion can be revoked if you pass through a 2-week washout period from the final day of probiotics, prebiotics, or synbiotics use)
3. Currently use laxatives
4. Are a smoker or use tobacco products
5. Consume >21 units of alcohol per week
6. Have donated blood in the previous 3 months
7. Have a BMI >30kg/m2
8. Are pregnant or lactating or planning to become pregnant for the duration of the study
9. Are dieting for weight loss or are following a low carbohydrate diet
10. Have participated in another clinical trial within the 30 days prior to study enrollment
11. Are currently taking certain medications or have a medical condition that could make it unsafe for you to participate or would affect the study assessments. Our team will look at your health information to decide if it's best for you not to participate
12. Are unwilling to maintain a similar exercise routine and eating habits for the duration of the study
13. Are unwilling to discontinue consumption of probiotics supplements and probiotic fortified products throughout the study
14. Have current injuries that limit exercise capacity
15. Are non-English speaking
Participate
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Additional information
Contact information
Kate Sales
Principal investigator:
Raylene Reimer De Bruyn
Clinical trial:
Yes
REB-ID:
REB23-1161