The Impact of a Regular Borjomi® Consumption on an Anaerobic Performance

NCT05494827 | Completed DMC

• 1 other identifier: 03/20
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Bicarbonate mineral water; Anaerobic performance; Acid-base balance

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (3)

• Changes of Acid-Base Balance

  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

  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

  4 times: visit 1 - baseline and after Wingate test; visit 2 - baseline and after Wingate test.

Study Arms (3)

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

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.

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.

Other: Regular consumption of still drinking water

Interventions

Regular consumption of natural mineral water Borjomi® with high bicarbonate content OTHER

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.

Also known as: Borjomi

Borjomi

Regular consumption of processed drinking water Smart Spring® OTHER

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.

Also known as: Smart Spring®

Smart Spring

Regular consumption of still drinking water OTHER

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.

Also known as: Water

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zaynudin Zaynudinov, MD, PhD: lead
• LLC IDS Borjomi: collaborator

Study Sites (1)

Department of Cardiovascular Pathology and Diet Therapy of Nutrition Clinic of The Federal Research Centre of Nutrition, Biotechnology and Food Safety

Moscow, 115446, Russia

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Zaynudin M. Zaynudinov, Dr

  Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The intervention (drinking water) was masked for participants through the same indistinguishable bottle design, whereas the taste of the water was different. The research team was unmasked as visits for participants from comparable groups assigned for separate days in order to prevent the possible discussion of water taste between groups.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: July 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data set was shared at December 2020 after the study completion.
• Access Criteria: Anonymous data set was shared for statistical analysis, manuscript preparation and power calculations of future research projects.

Locations

RU (1)