Effects of Caffeine in Hydration and Energy Metabolism

NCT01477294 | Completed

• 1 other identifier: IHS-2010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.Total body water and its compartments (intracellular and extracellular) assessed by by dilution techniques, and hydration state by urine specific gravity;
2. 2.Total energy expenditure by double labeled water, resting energy expenditure by indirect calorimetry, and physical activity energy expenditure;
3. 3.Energy expenditure in physical activity of daily living, in particular duration and intensity of activity.
4. 4.If the changes occurred between placebo and caffeine ingestion on the main outcomes were dependent on specific covariates, namely body composition and dietary intake.

Conditions

Caffeine

Keywords

Total; Intra and Extracellular Water; Energy Expenditure, Physical Activity; Body Composition; Dilution Techniques

Outcome Measures

Primary Outcomes (3)

• 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)

  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

  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

  day 4 and day 11

Secondary Outcomes (2)

• Changes in body composition from baseline to each condition (Placebo or Caffeine)

  day 0, day 4, and day 11

• Changes in dietary intake (energy and macro nutrient) between each condition (placebo and caffeine)

  Day 4 and day 11

Study Arms (2)

Caffeine

EXPERIMENTAL

Intervention with Caffeine in a random order

Drug: Caffeine

Placebo

PLACEBO COMPARATOR

Placebo (malt dextrin) administered in a random order

Drug: Placebo

Interventions

Caffeine DRUG

5 mg/ kg of body weight (capsules), twice a day (morning and afternoon), during 4 days.

Caffeine

Placebo DRUG

Malt dextrin (5 mg/kg body mass) twice a day during 4 days

Placebo

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Smokers
• taking medication or dietary supplements that may interfere with hydration status
• body composition or energy expenditure regulation
• Caffeine consumption \> 100 mg/day

Sponsors & Collaborators

• Technical University of Lisbon: lead

Study Sites (1)

Faculty of Human Kinetics

Lisbon, 1495-688, Portugal

Location

Related Publications (10)

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 40774622 DERIVED

• Silva 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.

  PMID: 24690589 DERIVED

• Judice 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.

  PMID: 23869233 DERIVED

• Silva 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.

  PMID: 23724879 DERIVED

• Judice 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.

  PMID: 23368828 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Analiza M Silva, PhD

  Faculty of Human Kinetics, Technical University of Lisbon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2011
• First Posted: November 22, 2011
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 22, 2011

Record last verified: 2011-11

Locations

PT (1)