Healthy Clinical Trial
Official title:
The Impact of a Regular Mineral Water With a High Content of Sodium Bicarbonate (Borjomi®) Consumption on Anaerobic Performance
NCT number | NCT05494827 |
Other study ID # | 03/20 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | December 31, 2020 |
The effects of 2 weeks 1000 ml daily mineral water Borjomy® consumption of anaerobic performance and acid-base balance in comparison with purified electrolite smart-water and still drinking water.
Status | Completed |
Enrollment | 51 |
Est. completion date | December 31, 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Normal body weight (BMI =18-24.90 kg/m2). - Regular physical activity - at least 150 minutes of exercise per week in 2 and more trainings. Exclusion Criteria: - Peak oxygen consumption less than 50% of the norm (adjusted for sex and age). - Allergic reactions to latex. - Smokers or quit-smokers (less than 6 month of withdrawal). - Any vitamin, sport or food supplementation in 3 month prior to participation. - Any low-limb trauma in 6 month prior to participation. - Any chronic diseases on permanent treatment. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Department of Cardiovascular Pathology and Diet Therapy of Nutrition Clinic of The Federal Research Centre of Nutrition, Biotechnology and Food Safety | Moscow |
Lead Sponsor | Collaborator |
---|---|
Zaynudin Zaynudinov, MD, PhD | LLC IDS Borjomi |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of Relative Peak Power (W/kg) | The Dynamic of Relative Peak Power was evaluated by repeated 30-seconds low limb Wingate anaerobic test with 7.5% from body mass workload in accordance with standard Wingate anaerobic test procedure with individual adjustment of angle and height of handlebar, seat height and foot straps. The test was preceded by a 5 min warm-up with a 4.5% from body mass workload. Wingate anaerobic test were performed by each participant on visit 1 (day 3) and visit 2 (day 16). On visit 0 (day 1) the training Wingate anaerobic test with 4.5% from body mass workload was conducted to familiarize the participants with the testing procedure. The day before testing, participants were asked to abstain from their routine training and other physical activities. | Twice: Baseline (visit 1) and in 2 weeks (visit 2). | |
Primary | Changes of Fatigue Index (%) | The Fatigue Index was evaluated as percentage of power lost by repeated 30-seconds low limb Wingate anaerobic test with 7.5% from body mass workload in accordance with standard Wingate anaerobic test procedure with individual adjustment of angle and height of handlebar, seat height and foot straps. The test was preceded by a 5 min warm-up with a 4.5% from body mass workload. The day before testing, participants were asked to abstain from their routine training and other physical activities. | Twice: Baseline (visit 1) and in 2 weeks (visit 2). | |
Secondary | Changes of Acid-Base Balance | Cubtal veins were catheterized with Peripheral venous catheters on visits 1 (day 3) and 2 (day 16) before Wingate anaerobic test. The venous blood samples were collected three times in rest, after Wingate anaerobic test, and after 5 minutes recovery-period on visits 1 (day 3) and 2 (day 16). After the last sample collection the catheter was removed (at the same day). The blood samples were immediately analyzed for Acid-Base Balance according to standard laboratory procedures. | 6 times: visit 1 - baseline, after Wingate test, and in 5 minutes recovery-period; visit 2 - baseline, after Wingate test, and in 5 minutes recovery-period. | |
Secondary | Changes of Lactate levels | Cubtal veins were catheterized with Peripheral venous catheters on visits 1 (day 3) and 2 (day 16) before Wingate anaerobic test. The venous blood samples were collected three times in rest, after Wingate anaerobic test, and after 5 minutes recovery-period on visits 1 (day 3) and 2 (day 16). After the last sample collection the catheter was removed (at the same day). The blood samples were immediately analyzed for Lactate levels according to standard laboratory procedures. | 6 times: visit 1 - baseline, after Wingate test, and in 5 minutes recovery-period; visit 2 - baseline, after Wingate test, and in 5 minutes recovery-period. | |
Secondary | Changes of Attention stability | Attention stability was assessed in rest and after Wingate anaerobic test on visits 1 (day 3) and 2 (day 16). For attention stability assessment the standard 5x5 Schulte Table testing with calculation of work efficiency, work warm-up and psychological stability was used. | 4 times: visit 1 - baseline and after Wingate test; visit 2 - baseline and after Wingate test. |
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