New forms for using Sodium Bicarbonate to improve physical performance during exercise and reduce side effects

New forms of Sodium Bicarbonate administration to enhance physical performance: an investigation into strategies to mitigate side-effects

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-4mnmwqs

Enrollment

Registered

2026-05-11

Start date

2026-03-12

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Signs and Symptoms Healthy Volunteers

Interventions

This is a randomized, double-blind, crossover, counterbalanced clinical trial. Twelve healthy (age between 18 and 40 years) individuals of both sexes who meet the established eligibility criteria will

Eligibility

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Adults of both sexes; healthy (without diagnosis, signs, or symptoms of chronic diseases), aged between 18 and 40 years

Exclusion criteria

Exclusion criteria: Presence of signs or symptoms of acute infectious disease; diagnosis of hypertension; diagnosis of renal insufficiency, use of medications that may affect gastric pH (e.g., proton pump inhibitors); and current or previous use of anabolic steroids

Design outcomes

Primary

Measure	Time frame
To evaluate the effects of new sodium bicarbonate supplementation strategies, involving the combination of enteric-coated tablets and gelatin capsules, on pharmacokinetic parameters and tolerability	—

Secondary

Measure	Time frame
To compare the pharmacokinetic parameters Cmax (maximum concentration), Tmax (time to peak), and area under the curve (AUC) of bicarbonate following sodium bicarbonate ingestion using the new strategies versus the conventional strategy. To compare the time required for blood HCO3? to reach ergogenic thresholds using the new strategies versus the conventional sodium bicarbonate supplementation strategy. To compare the duration for which blood bicarbonate remains above ergogenic thresholds using the new strategies versus the conventional supplementation strategy. The analysis of these markers will be performed through venous blood sampling, which will be arterialized using a thermal blanket applied to the forearm and hand. The first blood sample will be obtained before the ingestion of any supplement and 30 minutes after breakfast completion. Subsequent samples will be collected every 20 minutes during the first 3 hours and every 30 minutes during the following 3 hours, totaling a 6-hour assessment period. Collected blood samples will be analyzed using a blood gas analyzer ;To evaluate the incidence and severity of gastric and intestinal side effects resulting from sodium bicarbonate (NaHCO3) supplementation, comparing the new strategies versus the conventional strategy. Side effects will be recorded every 30 minutes using an adapted questionnaire assessing the intensity of gastric symptoms (belching, heartburn, nausea, stomach discomfort, and abdominal bloating); intestinal symptoms (flatulence, intestinal discomfort, and urgency to defecate); and other symptoms such as dizziness and headache	—

Measure

Time frame

To compare the pharmacokinetic parameters Cmax (maximum concentration), Tmax (time to peak), and area under the curve (AUC) of bicarbonate following sodium bicarbonate ingestion using the new strategies versus the conventional strategy. To compare the time required for blood HCO3? to reach ergogenic thresholds using the new strategies versus the conventional sodium bicarbonate supplementation strategy. To compare the duration for which blood bicarbonate remains above ergogenic thresholds using the new strategies versus the conventional supplementation strategy. The analysis of these markers will be performed through venous blood sampling, which will be arterialized using a thermal blanket applied to the forearm and hand. The first blood sample will be obtained before the ingestion of any supplement and 30 minutes after breakfast completion. Subsequent samples will be collected every 20 minutes during the first 3 hours and every 30 minutes during the following 3 hours, totaling a 6-hour assessment period. Collected blood samples will be analyzed using a blood gas analyzer ;To evaluate the incidence and severity of gastric and intestinal side effects resulting from sodium bicarbonate (NaHCO3) supplementation, comparing the new strategies versus the conventional strategy. Side effects will be recorded every 30 minutes using an adapted questionnaire assessing the intensity of gastric symptoms (belching, heartburn, nausea, stomach discomfort, and abdominal bloating); intestinal symptoms (flatulence, intestinal discomfort, and urgency to defecate); and other symptoms such as dizziness and headache

—

Countries

Contacts

Public ContactClaudine Adami

Faculdade de Medicina da Universidade de São Paulo

claudine.dullius@usp.br+5549988231785

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 11, 2026