HealthyNCT05494827
The Impact of a Regular Borjomi® Consumption on an Anaerobic Performance
A study testing Regular consumption of natural mineral water Borjomi® with high bicarbonate content, Regular consumption of processed drinking water Smart Spring® and Regular consumption of still drinking water in people with Healthy, run by Zaynudin Zaynudinov, MD, PhD at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Regular consumption of natural mineral water Borjomi® with high bicarbonate content, Regular consumption of processed drinking water Smart Spring® and Regular consumption of still drinking water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Department of Cardiovascular Pathology and Diet Therapy of Nutrition Clinic of The Federal Research Centre of Nutrition, Biotechnology and Food Safety
Moscow, 115446
About this study
Official title: The Impact of a Regular Mineral Water With a High Content of Sodium Bicarbonate (Borjomi®) Consumption on Anaerobic Performance
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Regular consumption of natural mineral water Borjomi® with high bicarbonate content, Regular consumption of processed drinking water Smart Spring®, Regular consumption of still drinking water
- Keywords
- Bicarbonate mineral water, Anaerobic performance, Acid-base balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular consumption of natural mineral water Borjomi® with high bicarbonate contentOther
Also called Borjomi
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®Other
Also called 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 waterOther
Also called Water
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.
| Study group | Role | What they receive |
|---|---|---|
| Borjomi | Experimental | 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 Receives: Other: Regular consumption of natural mineral water Borjomi® with high bicarbonate content |
| Smart Spring | Active comparator | 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. Receives: Other: Regular consumption of processed drinking water Smart Spring® |
| Control group | Placebo comparator | 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. Receives: Other: Regular consumption of still drinking water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twice: Baseline (visit 1) and in 2 weeks (visit 2).
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.
Measured: Twice: Baseline (visit 1) and in 2 weeks (visit 2).
Secondary outcomes (3)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 4 times: visit 1 - baseline and after Wingate test; visit 2 - baseline and after Wingate test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Jul 2020
- Primary completion30 Sep 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zaynudin Zaynudinov, MD, PhD
- Sponsor type
- Other government
- Collaborators
- LLC IDS Borjomi
- Responsible party
- Sponsor-investigator, Zaynudin Zaynudinov, MD, PhD, Federal State Budgetary Scientific Institution
- Investigators
- Zaynudin M. Zaynudinov, Dr, Principal investigator, Federal State Budgetary Scientific Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494827
- Sponsor's protocol ID
- 03/20
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The whole data set was shared with LLC IDS Borjomi (funding provider) after personal data (name, 2nd name and surname) were changed to individual participants numbers (ID).
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Regular Mineral Water With a High Content of Sodium Bicarbonate (Borjomi®) Consumption on Anaerobic Performance
- ClinicalTrials.gov ID
- NCT05494827
- Acronym / sponsor ID
- 03/20
- Conditions
- Healthy
- Keywords
- Bicarbonate mineral water, Anaerobic performance, Acid-base balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Zaynudin Zaynudinov, MD, PhDOther government
- Collaborators
- LLC IDS Borjomi
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Borjomi | Experimental | Other: Regular consumption of natural mineral water Borjomi® with high bicarbonate contentHealthy 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 |
| Smart Spring | Active comparator | Other: Regular consumption of processed drinking water 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. |
| Control group | Placebo comparator | Other: Regular consumption of still drinking waterHealthy 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular consumption of natural mineral water Borjomi® with high bicarbonate contentAlso: BorjomiNatural 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 | Borjomi |
| Regular consumption of processed drinking water Smart Spring®Also: 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. | Other | Smart Spring |
| Regular consumption of still drinking waterAlso: WaterStill 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 | Control group |
Primary outcome
Changes of Relative Peak Power (W/kg)
Time frame: Twice: Baseline (visit 1) and in 2 weeks (visit 2).
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.
Changes of Fatigue Index (%)
Time frame: Twice: Baseline (visit 1) and in 2 weeks (visit 2).
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.
3 secondary outcomes
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.
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.
Changes of Attention stability
Time frame: 4 times: visit 1 - baseline and after Wingate test; visit 2 - baseline and after Wingate test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: Yes. The whole data set was shared with LLC IDS Borjomi (funding provider) after personal data (name, 2nd name and surname) were changed to individual participants numbers (ID).
Related trials for Healthy
Recruiting
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
Brain Mapping, Healthy Volunteer
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaynudin M. Zaynudinov, Dr principal investigator
Federal State Budgetary Scientific Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular consumption of natural mineral water Borjomi® with high bicarbonate content, Regular consumption of processed drinking water Smart Spring® and Regular consumption of still drinking water in people with Healthy, run by Zaynudin Zaynudinov, MD, PhD at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Relative Peak Power (W/kg) (time frame: Twice: Baseline (visit 1) and in 2 weeks (visit 2).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.