None listed
Conditions
Brief summary
The research comprises a randomized, placebo-controlled, double-blind trial to evaluate the safety, tolerability, and physiological effects of a hydrogel-encapsulated sodium bicarbonate formulation co-delivered with caffeine and carbohydrates. The study seeks to establish whether this intervention improves exercise tolerance, with minimal adverse effects, in healthy volunteers. Phase 1 will involve 16 healthy adults (8 per group). Participants will complete two test visits. During the first visit participants will undertake a cycling based exercise test (INSCYD lactate test) to define baseline exercise tolerance. During the second visit, 96 hours later, they will ingest either the active hydrogel formulation or a placebo hydrogel before undertaking the same INSCYD lactate test. Physiological responses will be assessed using capillary lactate sampling, venous blood gas (VBG) analysis, and subjective effort ratings. Tolerability will be evaluated using GI symptom questionnaires, palatability scores, and protocol adherence. Performance outcomes will include maximal 4-minute power output, and detailed metabolic profiling via INSCYD software. Statistical analyses will include repeated-measures ANOVA and chi-square tests for tolerability. Both intention-to-treat and per-protocol analyses will be conducted.
Interventions
The research comprises a randomised double-blind placebo-controlled trial to evaluate the safety, tolerability, and physiological effects of a hydrogel-encapsulated sodium bicarbonate formulation co-delivered with caffeine and carbohydrates. The study seeks to establish whether this intervention improves exercise tolerance and mitigates symptoms of fatigue.
Phase 1 will involve 16 healthy adults (8 per intervention and control group). Participants will complete two test visits at the laborator
The research comprises a randomised double-blind placebo-controlled trial to evaluate the safety, tolerability, and physiological effects of a hydrogel-encapsulated sodium bicarbonate formulation co-delivered with caffeine and carbohydrates. The study seeks to establish whether this intervention improves exercise tolerance and mitigates symptoms of fatigue. Phase 1 will involve 16 healthy adults (8 per intervention and control group). Participants will complete two test visits at the laboratory in the Flinders University Health and Medicine Research building. During the first visit participants will undertake a cycling based exercise test (INSCYD lactate test) to define baseline exercise tolerance. During the second visit, 96 hours later, they will orally ingest either an active hydrogel formulation containing 0.25 g/kg of body mass of sodium bicarbonate (90 min pre-exercise), as well as 100 mg caffeine and 25 g of carbohydrate (45 min pre-exercise) before undertaking the same INSCYD lactate test. To ensure adherence, treatment ingestion will occur under researcher supervision. Physiological responses will be assessed using capillary lactate sampling, venous blood gas analysis, and subjective effort ratings. Tolerability will be evaluated using gastrointestinal distress symptom questionnaires, palatability scores, and protocol adherence.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must meet all of the following criteria: 1. Aged over 18 to under 65 years. 2. Body mass index (BMI) between 18–30 kg/m². 3. Recreationally active, defined as participating in structured physical activity at least twice per week. 4. Able and willing to provide written informed consent. 5. Able to attend all scheduled study visits and comply with study procedures.
Exclusion criteria
1. Cardiovascular risk/conditions: known coronary artery disease, heart failure, clinically significant valvular disease, uncontrolled or labile hypertension, history of syncope/arrhythmia or clinically significant palpitations, or any ACSM contraindication to maximal/submaximal exercise testing. 2. Respiratory disease that limits safe exercise testing (e.g., unstable asthma, COPD exacerbation). 3. Renal impairment or history of clinically significant electrolyte disorders; known predisposition to alkalosis. 4. Gastrointestinal disease likely to worsen with oral supplements (e.g., active peptic ulcer disease, inflammatory bowel disease flare, severe GERD), prior or existing severe (Grade =3) treatment-related GI toxicity, or prior GI surgery that materially affects absorption. 5. Metabolic/endocrine disorders that increase risk with bicarbonate/caffeine or confound outcomes (e.g., uncompensated thyroid disease, untreated metabolic acidosis/alkalosis). 6. Diabetes requiring medication or unstable glycaemic control (risk of adverse glycaemic responses to carbohydrate/caffeine). 7. Bleeding risk: coagulopathy or use of anticoagulants/antiplatelets at doses that meaningfully increase bleeding risk from venipuncture/capillary sampling. 8. Neurological or psychiatric conditions that would preclude consent, protocol adherence, or safe exercise (e.g. uncontrolled anxiety/panic disorder relevant to caffeine ingestion). 9. Allergy/intolerance to any study product or excipient (sodium bicarbonate, caffeine, maltodextrin/fructose, hydrogel components). 10. Medication/supplement conflicts: current use of agents that materially affect acid–base balance or lactate kinetics (e.g., acetazolamide), or other performance-enhancing supplements within washout periods (see below). 11. Substance use likely to interfere with safety or data integrity (investigator judgement). 12. Pregnancy or lactation (self-report and/or testing as per institutional policy). 13. Acute illness/infection within 14 days (e.g., febrile illness) or any condition that, in the opinion of the investigator, makes participation unsafe. 14. Inability to safely complete cycling ergometer testing (e.g., limiting musculoskeletal injury). 15. Participation in another interventional trial within 30 days or concurrent participation that could confound outcomes. Standard washouts ): 1. Beta-alanine use within the past 6 months. 2. Other ergogenic aids (e.g., nitrate/beetroot, high-dose sodium bicarbonate outside the study, creatine loading) within 4 weeks unless otherwise approved by the PI. 3. Caffeine on the day of testing outside the protocol (participants must abstain per pre-test instructions).
Outcome results
None listed