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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2022
Source Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Bicarbonate supplementation increases the efficiency of the body's buffer systems and improves anaerobic performance in athletes when taking bicarbonate just before training. In the course of studies, a similar effect was confirmed for professional swimmers at a distance of 200 meters freestyle, cyclists at distances up to 3 km and track and field athletes in steeplechase. However, these studies were conducted on professional male athletes, and it is interesting to compare the effects with non-athletes population. Borjomi® is a natural bicarbonate sodium mineral water with high taste qualities. The effects of Borjomi® as bicarbonate source on physical performance are another research interest. The aim of this study was to evaluate the comparative effectiveness of the regular use of bicarbonate-containing mineral water (Borjomi®) on anaerobic performance and acid-base balance during short-term physical activity of high intensity in comparison with purified electrolite smart-water and still drinking water.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Regular consumption of natural mineral water Borjomi® with high bicarbonate content
Natural mineral water Borjomi® is a transparent mineral water with specific alkaline taste and smell. The chemical composition includes sodium hydrocarbonate (HCO2-) 3995 mg/l (3500-5000 mg/l), chlorides (Cl-) 360 mg/l (250-500 mg/l), and nitrites (NO2-) <0.005 mg/l (up to 1 mg/l). The "Borjomi" water was packaged into standardized unlabeled 500 ml bottles. Participants were prescribed with 2 bottles (1000 ml) of daily consumption for 14 days. In order to maintain their usual water regimen, the participants additionally consumed steal drinking water on demand. The day before testing, participants were asked to abstain from their routine training and other physical activities.
Regular consumption of processed drinking water Smart Spring®
Processed drinking water Smart Spring® has no colour and smell with delicate specific taste. The chemical composition includes sodium (Na+) 33.6 mg/l, magnesium (Mg2+) 10.03 mg/l, calcium (Ca2+) 34.57 mg/l, chlorides (Cl-) 69.79 mg/l, sulfates (SO42-) 22.00 mg/l, and hydrocarbonates (HCO2-) 96.48 mg/l. The Smart Spring® water was packaged into standardized unlabeled 500 ml bottles. Participants were prescribed with 2 bottles (1000 ml) of daily consumption for 14 days. In order to maintain their usual water regimen, the participants additionally consumed steal drinking water on demand. The day before testing, participants were asked to abstain from their routine training and other physical activities.
Regular consumption of still drinking water
Still drinking water ?????? ????????®is a standard steal drinking water, that has no colour, taste, and smell. The ?????? ????????® water was packaged into standardized unlabeled 500 ml bottles. Participants were prescribed with 2 bottles (1000 ml) of daily consumption for 14 days. In order to maintain their usual water regimen, the participants additionally consumed steal drinking water on demand. Participants were asked to abstain from mineral water consumption for the entire observation period.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Zaynudin Zaynudinov, MD, PhD LLC IDS Borjomi

Country where clinical trial is conducted

Russian Federation, 

Outcome

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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