Consistencies in Responses to Sodium Bicarbonate?

Sports Nutritional Physiological Phenomena Clinical Trial

Official title:

Consistencies in Responses to Sodium Bicarbonate Supplementation: a Randomised, Repeated Measures, Counterbalanced and Double-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474628
• Other study ID #: Sodium bicarbonate consistency
• Status: Completed
• Phase: N/A
• First received: June 8, 2015
• Last updated: June 17, 2015
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Intervention studies do not account for high within-individual variation potentially compromising the magnitude of an effect. Repeat administration of a treatment allows quantification of individual responses and determination of the consistency of responses. The investigators aim to determine the consistency of metabolic and exercise responses following repeated administration of sodium bicarbonate (SB). Design and Methods: 15 physically active males will complete six cycling capacity tests at 110% of maximum power output (CCT110%) following ingestion of either 0.3 g∙kg-1Body Mass of SB (4 trials) or placebo (PL, 2 trials). Blood pH, bicarbonate, base excess and lactate will be determined at baseline, pre-exercise, post-exercise and 5-min post-exercise. Total work done (TWD) will be recorded as the exercise outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• recreationally active males

Exclusion Criteria:

• use of dietary supplements in the past 6 months

• the presence of any musculoskeletal disorder

• the use of anabolic steroids

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Sports Nutritional Physiological Phenomena

Intervention

Dietary Supplement:
• sodium bicarbonate

• calcium carbonate

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pH		5 min after a physical exercise test	No
Secondary	blood bicarbonate		5 min after a physical exercise test	No
Secondary	blood lactate		5 min after a physical exercise test	No
Secondary	anaerobic exercise capacity	as assessed by cycling capacity tests at 110% of maximum power output	4 hours after supplementation	No