Caffeine Clinical Trial
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:
1. Total body water and its compartments (intracellular and extracellular) assessed by by
dilution techniques, and hydration state by urine specific gravity;
2. Total energy expenditure by double labeled water, resting energy expenditure by
indirect calorimetry, and physical activity energy expenditure;
3. Energy expenditure in physical activity of daily living, in particular duration and
intensity of activity.
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.
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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