Blood, Muscle and Exercise Responses to Sodium Bicarbonate Supplementation

Sports Nutritional Physiological Phenomena Clinical Trial

Official title:

Blood and Muscle Responses to Sodium Bicarbonate Supplementation and Subsequent Exercise Performance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03505970
• Other study ID #: SB_BloodMuscle
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2019
• Est. completion date: December 2020

Study information

• Verified date: June 2019
• Source: University of Sao Paulo
• Contact: Bruno Gualano, PhD
• Phone: 3061-8789
• Email: gualano[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the changes in activity of transporters of H+ (monocarboxylate transporters; MCT1, MCT4, NHE) following sodium bicarbonate supplementation and subsequent exercise performance. Fifteen healthy men (age 18-35 years) will be invited to attend the laboratory on five separate visits to a randomized, double-blind, placebo-controlled study. Participants will be supplemented with a 0.3 g/kg dose of sodium bicarbonate or placebo (Analytical Pharmacy, Brazil) in opaque gelatin capsules. One hour after supplementation they will perform a 1-km time trial and every 10 minutes a blood sample will be collected. A muscle biopsy will be taken prior to supplementation, immediately prior to exercise, and immediately post-exercise. A questionnaire will be also used to evaluate the side-effects associated with sodium bicarbonate supplementation. Muscle and blood samples will be analysed for acidity and H+ and muscle samples will be analysed for H+ transporters (MCT1, MCT4, NHE).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy males

Exclusion Criteria:

• Smokers

• Chronic disease

• Prior or current use of steroids

• Use of creatine in the last 6 months

• Use of beta-alanine in the last 6 months

Related Conditions & MeSH terms

• Sports Nutritional Physiological Phenomena

Intervention

Dietary Supplement:
• Sodium bicarbonate
Sodium bicarbonate in powder form ingested in gelatine capsules. This leads to an increase bicarbonate concentration in blood, increasing buffering capacity which may lead to improvements in exercise
• Maltodextrin
Maltodextrin will be used as a placebo as it will not lead to any increases in circulating bicarbonate and, at this dose, will not likely have any physiological effect.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H+ transporter activity	Change in activity of transporters related to H+	5 minutes Post-exercise
Secondary	Exercise performance	Change in 1 km cycling time-trial performance	1 hour Post-supplementation