CaffeineNCT01477294
Effects of Caffeine in Hydration and Energy Metabolism
A study testing Caffeine in people with Caffeine, run by Technical University of Lisbon at 1 site in Portugal.
Trial summary
The main purposes of this randomized cross-over trial are to characterize and compare the effects of a moderate dose of caffeine intake in healthy physically active males on hydration and energy metabolism specifically: 1. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Caffeine
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2010to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- aged 18-39 years old
- body mass index between 18.5 and 29.9 kg/m2
- Subjects had to be free of any major disease with a general healthy status warranted
Who cannot join
- Smokers
- taking medication or dietary supplements that may interfere with hydration status
- body composition or energy expenditure regulation
- Caffeine consumption > 100 mg/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Caffeine Ingestion in Total-body Water, Extra and Intracellular Water Distribution, and Energy Metabolism
The main purposes of this randomized cross-over trial are to characterize and compare the effects of a moderate dose of caffeine intake in healthy physically active males on hydration and energy metabolism specifically:
- Total body water and its compartments (intracellular and extracellular) assessed by by dilution techniques, and hydration state by urine specific gravity;
- Total energy expenditure by double labeled water, resting energy expenditure by indirect calorimetry, and physical activity energy expenditure;
- Energy expenditure in physical activity of daily living, in particular duration and intensity of activity.
- If the changes occurred between placebo and caffeine ingestion on the main outcomes were dependent on specific covariates, namely body composition and dietary intake.
Read the detailed description
Although the effect of caffeine on hydration status, usually assessed by a urine specific gravity test (USG) has been extensively studied no research has been conducted to analyze its effects on total body water and its compartments using reference methods. In addition some uncertainty still remains about the influence of caffeine ingestion on hydration due to methodological limitations, specifically the use of less valid techniques for total-body water assessment, small sample size, and the lack of control for potential confounding factors. The information above specifically the methodological gaps mentioned and an inadequate experimental design lead us to further understand the effect of a moderate dose of caffeine in total body water (TBW) and its intra (ICW) and extracellular (ECW) compartments in non-caffeine consumers during a short-term period (4 days). Additionally, though caffeine effects on energy expenditure has been studied, its influence on physical activity (PA) during free-living conditions using gold standard and objective measures of PA is limited. Therefore, we also investigated the impact of a moderate dose of caffeine on resting energy expenditure (REE), PA energy expenditure (PAEE), total energy expenditure (TEE), and daily time spent in sedentary (DTSS), light (DTSL), moderate (DTSM), and vigorous (DTSV) intensity activities in non-obese physically active males. To overcome the methodological gaps in previous studies we assessed dietary intake and objective measures of physical activity throughout the experimental trial to assure that the same diet and physical activity patterns were maintained. Also it was analyzed if the effect of caffeine was independent of body composition, assessed by dual-energy x-ray absorptiometry.
To perform this research study, a total of 30 non-smoker males, low caffeine users (<100 mg/day), aged 20-39 yrs [body mass (BM): 72.7 ± 8.8 kg; Height: 1.77 ± 0.07 m] were followed in a double-blind crossover experimental design with two conditions in a random sequence: caffeine (5 mg per kg of BM/day) and malt-dextrine as placebo, both through capsules. Conditions lasted for 4 days with a 3-day washout period.
Evaluations were performed at baseline (visit-1), end of condition 1 (visit-2), and end of condition 2 (visit-3). Fat and fat-free masses (FFM) were assessed by dual energy x-ray absorptiometry. TBW and ECW were determined by dilution techniques (deuterium and bromide, specifically) while ICW was calculated as the difference between TBW and ECW (Schoeller et al., 1980. Total body water measurement in humans with 18O and 2H labeled water. Am J Clin Nutr 33:2686-2693). TEE was assessed using doubly labeled water technique by administrating two stable isotopes 2H (deuterium) and 18O (oxygen 18) with a respective dose of 0.1 g / kg and 1.8 g / kg of body water (Schoeller DA, van Santen E, 1982. Measurement of energy expenditure in humans by doubly labeled water method. J Appl Physiol 53:955-959). REE was assessed by indirect calorimetry and PAEE calculated as [TEE-(REE+0.1TEE)]. An accelerometer (ActiGraph, GT1M model, Fort Walton Beach, Florida) was used to estimate DTSS, DTSL, DTSM, and DTSV. The cutoff values used to define the intensity of physical activity and therefore to quantify the mean time in each intensity (sedentary, light, moderate or vigorous) for persons aged 18 years or older were: sedentary: < 100 counts/min; light: 100-2019 counts/min; moderate: 2,020-5,998 counts/min (corresponding to 3-5.9 METs); vigorous: ≥ 5999 counts/min (corresponding to ≥ 6 METs) (Troiano et al. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc. 2008;40:181-8).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
5 mg/ kg of body weight (capsules), twice a day (morning and afternoon), during 4 days.
PlaceboDrug
Malt dextrin (5 mg/kg body mass) twice a day during 4 days
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | Intervention with Caffeine in a random order Receives: Drug: Caffeine |
| Placebo | Placebo comparator | Placebo (malt dextrin) administered in a random order Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Total body water (TBW), extracellular water (ECW), intracellular water (ICW), and hydration status from baseline to each experimental condition (Placebo or Caffeine)
TBW was assessed by deuterium dilution using a stable Hydra gas isotope ratio mass spectrometer (PDZ, Europa Scientific, Crewe, United Kingdom).ECW was assessed by the sodium bromide dilution method. ICW was calculated as the difference between TBW and ECW. Hydration status was determined based on urine specific gravity (USG) measured by a refractrometer (Urisys 1100 Urine Analyzer, Roche, Portugal)
Measured: day 0, day 4, and day 11
Changes in total energy expenditure (TEE), resting energy expenditure (REE), and physical activity energy expenditure (PAEE) between each experimental conditions (placebo or caffeine)
TEE was assessed by the double labeled water technique, REE by indirect calorimetry, and PAEE calculated as PAEE= TEE - (0.1xTEE + REE), assuming that 10% of TEE is due to the thermogenic effect of food
Measured: Day 4 and day 11
Changes in daily time spent in sedentary activities (DTSS), light activities (DTSL), moderate activities (DTSM), and vigorous activities (DTSV) between each experimental conditions (placebo or caffeine)
DTSS, DTSL, DTSM, and DTCV were assessed by accelerometry using cut-off values based on specific counts/min interval
Measured: day 4 and day 11
Secondary outcomes (2)
Changes in body composition from baseline to each condition (Placebo or Caffeine)
Body composition was assessed by dual energy x-ray absorptiometry (DXA)
Measured: day 0, day 4, and day 11
Changes in dietary intake (energy and macro nutrient) between each condition (placebo and caffeine)
Dietary intake was assessed using a 24-h dietary records.
Measured: Day 4 and day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CaffeineStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Lisbon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Analiza M Silva, PhD, Technical University of Lisbon
- Investigators
- Analiza M Silva, PhD, Principal investigator, Faculty of Human Kinetics, Technical University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477294
- Sponsor's protocol ID
- IHS-2010
- Status last verified
- Nov 2011
- First submitted
- 11 Nov 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Silva AM, Armada-da-Silva P, Sardinha LB, Júdice PB, Magalhães JP, Matias CN & Santos DA. Efeitos da ingestão de cafeína na água corporal total, distribuição de fluidos intra e extracelulares e no dispêndio energético. A Report for the Institution of Hydration and Health, In press.
Júdice PB (2011). Determinant Factors on hydration status assessed by Urine Specific Gravity: accuracy of technical procedures and effect of caffeine ingestion. Master's Degree Thesis. Faculty of Human Kinetics-Technical University of Lisbon, Cruz-Quebrada.
Magalhães JP, Santos DA, Silva AM, Matias CN, Júdice PB, Quintas IC, Sardinha LB (2011). Total energy expenditure: combined heart rate and motion sensor vs uni-axial accelerometry models Book of abstracts of the International conference on Recent Advances and Controversies in Measuring Energy Metabolism, pp 106.
Quintas IC, Santos DA, Matias CN, Silva AM, Gobbo, LA, Gonçalves EM, Magalhães JP, Júdice PB, Sardinha LB (2011). Does caffeine intake affect resting energy expenditure? Book of abstracts of the International conference on Recent Advances and Controversies in Measuring Energy Metabolism, pp 104.
Júdice PB, Silva AM, Magalhães JP, Matias CN, Santos DA, Armada-da-Silva P, & Sardinha LB. Does caffeine intake increases energy expenditure and habitual physical activity? A double-blind randomized crossover trial. Medicine and Science in Sports and Exercise. In Review.
Francisco R, Rosa GB, Judice PB, Magalhaes JP, Cruz AD, Sardinha LB, Lukaski HC, Silva AM. Four days of a moderate dose of caffeine does not alter raw bioelectrical impedance analysis parameters in healthy males. Clin Nutr ESPEN. 2025 Oct;69:599-607. doi: 10.1016/j.clnesp.2025.08.005. Epub 2025 Aug 6.
PubMed 40774622Silva AM, Santos DA, Matias CN, Judice PB, Magalhaes JP, Ekelund U, Sardinha LB. Accuracy of a combined heart rate and motion sensor for assessing energy expenditure in free-living adults during a double-blind crossover caffeine trial using doubly labeled water as the reference method. Eur J Clin Nutr. 2015 Jan;69(1):20-7. doi: 10.1038/ejcn.2014.51. Epub 2014 Apr 2.
PubMed 24690589Judice PB, Matias CN, Santos DA, Magalhaes JP, Hamilton MT, Sardinha LB, Silva AM. Caffeine intake, short bouts of physical activity, and energy expenditure: a double-blind randomized crossover trial. PLoS One. 2013 Jul 15;8(7):e68936. doi: 10.1371/journal.pone.0068936. Print 2013.
PubMed 23869233Silva AM, Judice PB, Matias CN, Santos DA, Magalhaes JP, St-Onge MP, Goncalves EM, Armada-da-Silva P, Sardinha LB. Total body water and its compartments are not affected by ingesting a moderate dose of caffeine in healthy young adult males. Appl Physiol Nutr Metab. 2013 Jun;38(6):626-32. doi: 10.1139/apnm-2012-0253. Epub 2013 Jan 15.
PubMed 23724879Judice PB, Magalhaes JP, Santos DA, Matias CN, Carita AI, Armada-Da-Silva PA, Sardinha LB, Silva AM. A moderate dose of caffeine ingestion does not change energy expenditure but decreases sleep time in physically active males: a double-blind randomized controlled trial. Appl Physiol Nutr Metab. 2013 Jan;38(1):49-56. doi: 10.1139/apnm-2012-0145. Epub 2013 Jan 18.
PubMed 23368828
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Caffeine Ingestion in Total-body Water, Extra and Intracellular Water Distribution, and Energy Metabolism
- ClinicalTrials.gov ID
- NCT01477294
- Acronym / sponsor ID
- IHS-2010
- Conditions
- Caffeine
- Keywords
- Total, Intra and Extracellular Water, Energy Expenditure, Physical Activity, Body Composition, Dilution Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Technical University of LisbonUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 22 Nov 2011 (estimated)
- 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.
The main purposes of this randomized cross-over trial are to characterize and compare the effects of a moderate dose of caffeine intake in healthy physically active males on hydration and energy metabolism specifically:
- Total body water and its compartments (intracellular and extracellular) assessed by by dilution techniques, and hydration state by urine specific gravity;
- Total energy expenditure by double labeled water, resting energy expenditure by indirect calorimetry, and physical activity energy expenditure;
- Energy expenditure in physical activity of daily living, in particular duration and intensity of activity.
- If the changes occurred between placebo and caffeine ingestion on the main outcomes were dependent on specific covariates, namely body composition and dietary intake.
Detailed description
Although the effect of caffeine on hydration status, usually assessed by a urine specific gravity test (USG) has been extensively studied no research has been conducted to analyze its effects on total body water and its compartments using reference methods. In addition some uncertainty still remains about the influence of caffeine ingestion on hydration due to methodological limitations, specifically the use of less valid techniques for total-body water assessment, small sample size, and the lack of control for potential confounding factors. The information above specifically the methodological gaps mentioned and an inadequate experimental design lead us to further understand the effect of a moderate dose of caffeine in total body water (TBW) and its intra (ICW) and extracellular (ECW) compartments in non-caffeine consumers during a short-term period (4 days). Additionally, though caffeine effects on energy expenditure has been studied, its influence on physical activity (PA) during free-living conditions using gold standard and objective measures of PA is limited. Therefore, we also investigated the impact of a moderate dose of caffeine on resting energy expenditure (REE), PA energy expenditure (PAEE), total energy expenditure (TEE), and daily time spent in sedentary (DTSS), light (DTSL), moderate (DTSM), and vigorous (DTSV) intensity activities in non-obese physically active males. To overcome the methodological gaps in previous studies we assessed dietary intake and objective measures of physical activity throughout the experimental trial to assure that the same diet and physical activity patterns were maintained. Also it was analyzed if the effect of caffeine was independent of body composition, assessed by dual-energy x-ray absorptiometry.
To perform this research study, a total of 30 non-smoker males, low caffeine users (<100 mg/day), aged 20-39 yrs [body mass (BM): 72.7 ± 8.8 kg; Height: 1.77 ± 0.07 m] were followed in a double-blind crossover experimental design with two conditions in a random sequence: caffeine (5 mg per kg of BM/day) and malt-dextrine as placebo, both through capsules. Conditions lasted for 4 days with a 3-day washout period.
Evaluations were performed at baseline (visit-1), end of condition 1 (visit-2), and end of condition 2 (visit-3). Fat and fat-free masses (FFM) were assessed by dual energy x-ray absorptiometry. TBW and ECW were determined by dilution techniques (deuterium and bromide, specifically) while ICW was calculated as the difference between TBW and ECW (Schoeller et al., 1980. Total body water measurement in humans with 18O and 2H labeled water. Am J Clin Nutr 33:2686-2693). TEE was assessed using doubly labeled water technique by administrating two stable isotopes 2H (deuterium) and 18O (oxygen 18) with a respective dose of 0.1 g / kg and 1.8 g / kg of body water (Schoeller DA, van Santen E, 1982. Measurement of energy expenditure in humans by doubly labeled water method. J Appl Physiol 53:955-959). REE was assessed by indirect calorimetry and PAEE calculated as [TEE-(REE+0.1TEE)]. An accelerometer (ActiGraph, GT1M model, Fort Walton Beach, Florida) was used to estimate DTSS, DTSL, DTSM, and DTSV. The cutoff values used to define the intensity of physical activity and therefore to quantify the mean time in each intensity (sedentary, light, moderate or vigorous) for persons aged 18 years or older were: sedentary: < 100 counts/min; light: 100-2019 counts/min; moderate: 2,020-5,998 counts/min (corresponding to 3-5.9 METs); vigorous: ≥ 5999 counts/min (corresponding to ≥ 6 METs) (Troiano et al. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc. 2008;40:181-8).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Drug: CaffeineIntervention with Caffeine in a random order |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (malt dextrin) administered in a random order |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male
- aged 18-39 years old
- body mass index between 18.5 and 29.9 kg/m2
- Subjects had to be free of any major disease with a general healthy status warranted
Key exclusion criteria (4 listed)
- Smokers
- taking medication or dietary supplements that may interfere with hydration status
- body composition or energy expenditure regulation
- Caffeine consumption > 100 mg/day
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 |
|---|---|---|
| Caffeine5 mg/ kg of body weight (capsules), twice a day (morning and afternoon), during 4 days. | Drug | Caffeine |
| PlaceboMalt dextrin (5 mg/kg body mass) twice a day during 4 days | Drug | Placebo |
Primary outcome
Changes in Total body water (TBW), extracellular water (ECW), intracellular water (ICW), and hydration status from baseline to each experimental condition (Placebo or Caffeine)
Time frame: day 0, day 4, and day 11
TBW was assessed by deuterium dilution using a stable Hydra gas isotope ratio mass spectrometer (PDZ, Europa Scientific, Crewe, United Kingdom).ECW was assessed by the sodium bromide dilution method. ICW was calculated as the difference between TBW and ECW. Hydration status was determined based on urine specific gravity (USG) measured by a refractrometer (Urisys 1100 Urine Analyzer, Roche, Portugal)
Changes in total energy expenditure (TEE), resting energy expenditure (REE), and physical activity energy expenditure (PAEE) between each experimental conditions (placebo or caffeine)
Time frame: Day 4 and day 11
TEE was assessed by the double labeled water technique, REE by indirect calorimetry, and PAEE calculated as PAEE= TEE - (0.1xTEE + REE), assuming that 10% of TEE is due to the thermogenic effect of food
Changes in daily time spent in sedentary activities (DTSS), light activities (DTSL), moderate activities (DTSM), and vigorous activities (DTSV) between each experimental conditions (placebo or caffeine)
Time frame: day 4 and day 11
DTSS, DTSL, DTSM, and DTCV were assessed by accelerometry using cut-off values based on specific counts/min interval
2 secondary outcomes
Changes in body composition from baseline to each condition (Placebo or Caffeine)
Time frame: day 0, day 4, and day 11
Changes in dietary intake (energy and macro nutrient) between each condition (placebo and caffeine)
Time frame: Day 4 and day 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
- Results publicationSilva AM, Armada-da-Silva P, Sardinha LB, Júdice PB, Magalhães JP, Matias CN & Santos DA. Efeitos da ingestão de cafeína na água corporal total, distribuição de fluidos intra e extracelulares e no dispêndio energético. A Report for the Institution of Hydration and Health, In press.
- Results publicationJúdice PB (2011). Determinant Factors on hydration status assessed by Urine Specific Gravity: accuracy of technical procedures and effect of caffeine ingestion. Master's Degree Thesis. Faculty of Human Kinetics-Technical University of Lisbon, Cruz-Quebrada.
- Results publicationMagalhães JP, Santos DA, Silva AM, Matias CN, Júdice PB, Quintas IC, Sardinha LB (2011). Total energy expenditure: combined heart rate and motion sensor vs uni-axial accelerometry models Book of abstracts of the International conference on Recent Advances and Controversies in Measuring Energy Metabolism, pp 106.
- Results publicationQuintas IC, Santos DA, Matias CN, Silva AM, Gobbo, LA, Gonçalves EM, Magalhães JP, Júdice PB, Sardinha LB (2011). Does caffeine intake affect resting energy expenditure? Book of abstracts of the International conference on Recent Advances and Controversies in Measuring Energy Metabolism, pp 104.
- Results publicationJúdice PB, Silva AM, Magalhães JP, Matias CN, Santos DA, Armada-da-Silva P, & Sardinha LB. Does caffeine intake increases energy expenditure and habitual physical activity? A double-blind randomized crossover trial. Medicine and Science in Sports and Exercise. In Review.
- Derived from this study: PubMed 40774622Francisco R, Rosa GB, Judice PB, Magalhaes JP, Cruz AD, Sardinha LB, Lukaski HC, Silva AM. Four days of a moderate dose of caffeine does not alter raw bioelectrical impedance analysis parameters in healthy males. Clin Nutr ESPEN. 2025 Oct;69:599-607. doi: 10.1016/j.clnesp.2025.08.005. Epub 2025 Aug 6.
- Derived from this study: PubMed 24690589Silva AM, Santos DA, Matias CN, Judice PB, Magalhaes JP, Ekelund U, Sardinha LB. Accuracy of a combined heart rate and motion sensor for assessing energy expenditure in free-living adults during a double-blind crossover caffeine trial using doubly labeled water as the reference method. Eur J Clin Nutr. 2015 Jan;69(1):20-7. doi: 10.1038/ejcn.2014.51. Epub 2014 Apr 2.
- Derived from this study: PubMed 23869233Judice PB, Matias CN, Santos DA, Magalhaes JP, Hamilton MT, Sardinha LB, Silva AM. Caffeine intake, short bouts of physical activity, and energy expenditure: a double-blind randomized crossover trial. PLoS One. 2013 Jul 15;8(7):e68936. doi: 10.1371/journal.pone.0068936. Print 2013.
- Derived from this study: PubMed 23724879Silva AM, Judice PB, Matias CN, Santos DA, Magalhaes JP, St-Onge MP, Goncalves EM, Armada-da-Silva P, Sardinha LB. Total body water and its compartments are not affected by ingesting a moderate dose of caffeine in healthy young adult males. Appl Physiol Nutr Metab. 2013 Jun;38(6):626-32. doi: 10.1139/apnm-2012-0253. Epub 2013 Jan 15.
- Derived from this study: PubMed 23368828Judice PB, Magalhaes JP, Santos DA, Matias CN, Carita AI, Armada-Da-Silva PA, Sardinha LB, Silva AM. A moderate dose of caffeine ingestion does not change energy expenditure but decreases sleep time in physically active males: a double-blind randomized controlled trial. Appl Physiol Nutr Metab. 2013 Jan;38(1):49-56. doi: 10.1139/apnm-2012-0145. Epub 2013 Jan 18.
Related trials for Caffeine
RecruitingPhase 4
Improving Morning Strength and Cognitive Performance Using Caffeine or Whole-body Vibration.
Vibration Therapy, Caffeine
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Recruiting
The Effect of Short-term Supplementation of OliPhenolia® on Fat Oxidation
Healthy
Active, not recruitingPhase 4
A Study to See if an Energy Drink With Caffeine and Green Tea Increases Fat Burning When Exercising
Exercise
Not yet recruitingPhase 2
CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)
Meconium Aspiration Syndrome
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. This study is not recruiting at the moment.
Analiza M Silva, PhD principal investigator
Faculty of Human Kinetics, Technical University of Lisbon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Caffeine, run by Technical University of Lisbon at 1 site in Portugal.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Total body water (TBW), extracellular water (ECW), intracellular water (ICW), and hydration status from baseline to each experimental condition (Placebo or Caffeine) (time frame: day 0, day 4, and day 11). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01477294, which also lists 10 linked publications.
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 22 Nov 2011.