- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05494827
The Impact of a Regular Borjomi® Consumption on an Anaerobic Performance
The Impact of a Regular Mineral Water With a High Content of Sodium Bicarbonate (Borjomi®) Consumption on Anaerobic Performance
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Moscow, Russian Federation, 115446
- Department of Cardiovascular Pathology and Diet Therapy of Nutrition Clinic of The Federal Research Centre of Nutrition, Biotechnology and Food Safety
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Borjomi
Healthy volunteers (N16, 8 males and 8 females) 30.63±1.04 y.o. with BMI 22.17±0.75
kg/m2 were randomly allocated to Borjomi group.
Participants received 30 bottles (500 ml) of natural mineral water Borjomi® for daily 1000 ml (2 bottles) water consumption for 14 days (from visits 1 and 2).
Participants drank the first bottle on the visit 1 after the first study Wingate test and the last bottle on the visit 3 before the second study Wingate test
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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.
Other Names:
|
Active Comparator: Smart Spring
Healthy volunteers (N16, 8 males and 8 females) 28.56±1.61
y.o. with BMI 23.14±0.60
kg/m2 were randomly allocated to Smart Spring group.
Participants received 30 bottles (500 ml) of processed drinking water Smart Spring® for daily 1000 ml (2 bottles) water consumption for 14 days (from visits 1 and 2).
Participants drank the first bottle on the visit 1 after the first study Wingate test and the last bottle on the visit 3 before the second study Wingate test.
|
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.
Other Names:
|
Placebo Comparator: Control group
Healthy volunteers (N16, 8 males and 8 females) 30.69±1.74 y.o. with BMI 22.67±0.51
kg/m2 were randomly allocated to Control group.
Participants received 30 bottles (500 ml) of steal drinking water Святой Источник® for daily 1000 ml (2 bottles) water consumption for 14 days (from visits 1 and 2).
Participants drank the first bottle on the visit 1 after the first study Wingate test and the last bottle on the visit 3 before the second study Wingate test.
|
Still drinking water Святой Источник®is a standard steal drinking water, that has no colour, taste, and smell.
The Святой Источник® 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of Relative Peak Power (W/kg)
Time Frame: Twice: Baseline (visit 1) and in 2 weeks (visit 2).
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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.
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Twice: Baseline (visit 1) and in 2 weeks (visit 2).
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Changes of Fatigue Index (%)
Time Frame: Twice: Baseline (visit 1) and in 2 weeks (visit 2).
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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.
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Twice: Baseline (visit 1) and in 2 weeks (visit 2).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of Acid-Base Balance
Time Frame: 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.
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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.
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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.
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Changes of Lactate levels
Time Frame: 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.
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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.
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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.
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Changes of Attention stability
Time Frame: 4 times: visit 1 - baseline and after Wingate test; visit 2 - baseline and after Wingate test.
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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.
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4 times: visit 1 - baseline and after Wingate test; visit 2 - baseline and after Wingate test.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Zaynudin M. Zaynudinov, Dr, Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 03/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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