ExerciseNCT07840248
Betaine Addition to Water Loading Prior to Running Exercise
A study testing Anhydrous Betaine in people with Exercise and Hydration, run by Poznan University of Life Sciences.
Trial summary
This randomized, double-blind, placebo-controlled crossover study will investigate whether acute betaine ingestion as part of a pre-exercise hyperhydration strategy improves endurance running performance and influences hydration-related responses during prolonged exercise. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Anhydrous Betaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45 years
- Sex: men and premenopausal women
- Continuous running training for at least 12 months
- At least 3 running training sessions per week
- Willingness and ability to complete the treadmill exercise protocol: 60 minutes of running at 60% of the running velocity corresponding to VO₂max, followed by a 5-km running time trial
- Medical clearance for participation in maximal and prolonged exercise testing
Who cannot join
- Age <18 or >45 years
- Postmenopausal women
- Use of betaine, choline, folic acid/folate, or vitamin B12 supplements within 3 months prior to study participation
- Current musculoskeletal injury or injury occurring within the previous 2 months
- Uncontrolled arterial hypertension
- Pregnancy or breastfeeding
Show all 16Show fewer
- Diabetes requiring insulin therapy or inadequately controlled diabetes
- Active or severe liver disease, including ALT or AST >3× the upper limit of normal
- Renal impairment, including eGFR <60 mL/min/1.73 m²
- Untreated or unstable thyroid disease, including hypothyroidism or hyperthyroidism
- Gastrointestinal disease that may affect nutrient absorption
- Kidney disease, cardiovascular disease, irritable bowel syndrome, or adrenal disease
- Use of diuretics, SGLT2 inhibitors, laxatives, or glucocorticoids
- Any medical contraindication to physical exercise and/or failure to obtain medical clearance for exercise testing
- Elevated body temperature at the time of testing
- Cystic fibrosis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of a Betaine-Supplemented Hydration Protocol on Sweat Rate and Exercise Performance in Runners
This randomized, double-blind, placebo-controlled crossover study will investigate whether acute betaine ingestion as part of a pre-exercise hyperhydration strategy improves endurance running performance and influences hydration-related responses during prolonged exercise.
Approximately 30 recreationally trained male and premenopausal female runners will complete two experimental trials: a betaine condition and a placebo/control condition. In the betaine condition, participants will ingest anhydrous betaine at a dose of 0.07 g/kg body mass as part of a standardized pre-exercise hydration protocol providing a total fluid intake of approximately 25 mL/kg body mass.
Read more
Following the hydration protocol, participants will complete 60 minutes of treadmill running at 60% of the running velocity corresponding to VO₂max, followed by a 5-minute recovery period and a 5-km treadmill time trial.
The primary outcome will be 5-km running time-trial performance. Secondary outcomes will include exercise-induced fluid and sweat loss, urinary hydration markers, sweat electrolyte concentrations, physiological responses, exercise economy, substrate utilization, blood lactate concentration, perceived exertion, thirst, and thermal sensation.
- Being tested
- Anhydrous Betaine, Placebo
- Keywords
- betaine, hydration, endurance, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anhydrous BetaineDietary supplement
Anhydrous betaine (trimethylglycine) will be administered as a single dose of 0.07 g/kg body mass, dissolved in a commercially available sports drink (5 mL/kg body mass), 150 minutes before exercise. The betaine-containing drink will constitute the first bolus of a standardized pre-exercise hyperhydration protocol providing a total fluid intake of approximately 25 mL/kg body mass over 120 minutes.
PlaceboOther
Participants will receive the same commercially available sports drink (5 mL/kg body mass) without added betaine 150 minutes before exercise. This will be followed by four additional fluid boluses of mineral water (5 mL/kg each) administered at 120, 90, 60, and 30 minutes before exercise, for a total pre-exercise fluid intake of approximately 25 mL/kg body mass.
| Study group | Role | What they receive |
|---|---|---|
| Betaine → Placebo Sequence | Experimental | Participants will first complete the betaine-enriched hyperhydration condition. After the washout period, they will complete the placebo hyperhydration condition. Receives: Dietary Supplement: Anhydrous Betaine; Other: Placebo |
| Placebo → Betaine Sequence | Experimental | Participants will first complete the placebo hyperhydration condition. After the washout period, they will complete the betaine-enriched hyperhydration condition. Receives: Dietary Supplement: Anhydrous Betaine; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-km Running Time-Trial Performance
Time required to complete a 5-km treadmill running time trial, expressed in seconds. Participants will be instructed to complete the distance as quickly as possible and will be allowed to adjust treadmill speed throughout the trial. Lower completion time indicates better performance.
Measured: During the 5-km treadmill time trial performed after the 60-minute running preload and a 5-minute recovery period in each experimental trial.
Secondary outcomes (1)
Sweat rate
Whole-body sweat rate will be estimated from the change in body mass from immediately before exercise to completion of the 5-km time trial, adjusted for fluid intake and urine output, if applicable, and expressed as L/h. Body mass will be measured using the calibrated electronic scale integrated with the BOD POD system (COSMED, Italy) and expressed in kilograms (kg). Changes in body mass will also be calculated and reported as a percentage of pre-exercise body mass (%).
Measured: From immediately before the 60-minute running preload to completion of the subsequent 5-km time trial during each experimental trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilia Zawieja, Poznan University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840248
- Sponsor's protocol ID
- BETxSWEAT
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Betaine-Supplemented Hydration Protocol on Sweat Rate and Exercise Performance in Runners
- ClinicalTrials.gov ID
- NCT07840248
- Acronym / sponsor ID
- BETxSWEAT
- Keywords
- betaine, hydration, endurance, exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled crossover study will investigate whether acute betaine ingestion as part of a pre-exercise hyperhydration strategy improves endurance running performance and influences hydration-related responses during prolonged exercise.
Approximately 30 recreationally trained male and premenopausal female runners will complete two experimental trials: a betaine condition and a placebo/control condition. In the betaine condition, participants will ingest anhydrous betaine at a dose of 0.07 g/kg body mass as part of a standardized pre-exercise hydration protocol providing a total fluid intake of approximately 25 mL/kg body mass.
Following the hydration protocol, participants will complete 60 minutes of treadmill running at 60% of the running velocity corresponding to VO₂max, followed by a 5-minute recovery period and a 5-km treadmill time trial.
The primary outcome will be 5-km running time-trial performance. Secondary outcomes will include exercise-induced fluid and sweat loss, urinary hydration markers, sweat electrolyte concentrations, physiological responses, exercise economy, substrate utilization, blood lactate concentration, perceived exertion, thirst, and thermal sensation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betaine → Placebo Sequence | Experimental | Dietary Supplement: Anhydrous Betaine, Other: PlaceboParticipants will first complete the betaine-enriched hyperhydration condition. After the washout period, they will complete the placebo hyperhydration condition. |
| Placebo → Betaine Sequence | Experimental | Dietary Supplement: Anhydrous Betaine, Other: PlaceboParticipants will first complete the placebo hyperhydration condition. After the washout period, they will complete the betaine-enriched hyperhydration condition. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-45 years
- Sex: men and premenopausal women
- Continuous running training for at least 12 months
- At least 3 running training sessions per week
- Willingness and ability to complete the treadmill exercise protocol: 60 minutes of running at 60% of the running velocity corresponding to VO₂max, followed by a 5-km running time trial
Key exclusion criteria (16 listed)
- Age <18 or >45 years
- Postmenopausal women
- Use of betaine, choline, folic acid/folate, or vitamin B12 supplements within 3 months prior to study participation
- Current musculoskeletal injury or injury occurring within the previous 2 months
- Uncontrolled arterial hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anhydrous BetaineAnhydrous betaine (trimethylglycine) will be administered as a single dose of 0.07 g/kg body mass, dissolved in a commercially available sports drink (5 mL/kg body mass), 150 minutes before exercise. The betaine-containing drink will constitute the first bolus of a standardized pre-exercise hyperhydration protocol providing a total fluid intake of approximately 25 mL/kg body mass over 120 minutes. | Dietary supplement | Betaine → Placebo Sequence, Placebo → Betaine Sequence |
| PlaceboParticipants will receive the same commercially available sports drink (5 mL/kg body mass) without added betaine 150 minutes before exercise. This will be followed by four additional fluid boluses of mineral water (5 mL/kg each) administered at 120, 90, 60, and 30 minutes before exercise, for a total pre-exercise fluid intake of approximately 25 mL/kg body mass. | Other | Betaine → Placebo Sequence, Placebo → Betaine Sequence |
Primary outcome
5-km Running Time-Trial Performance
Time frame: During the 5-km treadmill time trial performed after the 60-minute running preload and a 5-minute recovery period in each experimental trial.
Time required to complete a 5-km treadmill running time trial, expressed in seconds. Participants will be instructed to complete the distance as quickly as possible and will be allowed to adjust treadmill speed throughout the trial. Lower completion time indicates better performance.
1 secondary outcome
Sweat rate
Time frame: From immediately before the 60-minute running preload to completion of the subsequent 5-km time trial during each experimental trial.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Anhydrous Betaine in people with Exercise and Hydration, run by Poznan University of Life Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilia Zawieja (+48500415726, emilia.zawieja@up.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-km Running Time-Trial Performance (time frame: During the 5-km treadmill time trial performed after the 60-minute running preload and a 5-minute recovery period in each experimental trial.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.