Asymptomatic Conditions Clinical Trial
Official title:
Effects of Caffeine and Coffee on Resting Metabolic Rate, Comparing Normal Weight Men to Obese Men
Background. The prevalence of obesity has increased in the last two decades. To maintain
body weight energy expenditure (EE) should be equal to energy intake (EI). A low EE
predisposes individuals to weight gain and to obesity that can also results from low resting
metabolic rate (RMR). Caffeine (Caf) is an active food ingredient and is widely consumed
globally, and has an important impact on energy balance. Caf reduces appetite (EI) and
increases EE, thus, Caf has a potential role in body weight reduction. Caf causes higher
total daily energy expenditure (TDEE) in normal weight (NW) people compared to obese (OW).
Moreover Caf is linked to decreased fat oxidation in OW. There are differences between OW
and NW in Caf pharmacokinetics, but no differences reported between NW and OW females in its
effects on RMR. There is a gender difference in the influence of Caf on metabolism. The
investigators are aware of no previous studies which compared the effect of Caf on the RMR
of NW and OW men.
Objectives. 1) To compare the effect of Caf and coffee on resting metabolic rate (RMR)
values in healthy normal-weight (NW) men and overweight (OW) men. 2) To develop Caf intake
frequency questionnaire (in Hebrew)
Hypothesis. RMR values will be higher and respiratory exchange ratio (RER) values will be
lower in NW compared to the values measured in OW men.
Methods. 33 men (16 NW and 17 OW) were reported to the laboratory on 4 separate occasions
(placebo, Caf tablets, coffee and decaffeinated coffee). During the lab sessions they were
undergo complete anthropometric measurements and RMR measured (one of the study conditions)
using indirect calorimetry. Additionally, respiratory exchange ratio (RER) which is
calculated as the ratio between CO2 production (VCO2) and O2 consumption (VO2) (VCO2/VO2),
blood pressure and heart rate (HR) response recorded.
The importance of this study is that the results will contribute to the scientific basis of
weight control and health interventions programs (diet and physical activity) in overweight
men.
Methods. 16 NW and 17 OW men were reported to the laboratory on 4 separate occasions
(placebo, Caf tablets, coffee and decaffeinated coffee) each separated by 2-7 days. Before
the first meeting they refill caffeine, physical activity and medical questionnaires. The
investigators recruited only men who were healthy non-smokers with no comorbidities and the
daily caffeine consumption was under 400 mg. Before each meeting participants had to comply
guidelines outlined included fasting for 8 hours, avoiding intense physical activity 14
hours and moderate exercise 2 hours before measurements. The meetings conducted in the
morning when the first session included anthropometric measurements (weight, height and
waist circumference) and body composition measurements using Bioelectrical Impedance
Analysis (BIA) and a digital caliper. Each session began with a measuring resting blood
pressure and heart rate (Polar telemetric systems), after that participants were given
randomly placebo or Caf tablets or coffee or decaffeinated coffee, waiting half an hour and
then measuring the RMR and respiratory exchange ratio (RER), for half an hour using indirect
calorimetry (canopy system). Then again measured blood pressure and heart rate at rest.
The sample size was calculated for 16 participant in each group, according to an expected
change of 3% at RMR values between the groups with the power of 80% and significance of 0.05
. standard deviation (SD).
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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