A Phase 3 interventional study of Caffeine and Placebo in Asymptomatic Conditions, sponsored by Tel Hai College. Completed. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-27.
Sponsored by Tel Hai College · Phase 3, Interventional, and Basic science
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).
36 studies on the registry are indexed under Asymptomatic Diseases; 8 are open to participants now.
This study's enrollment of 33 is below the median of 50 across 26 interventional studies indexed under Asymptomatic Diseases.
Browse Asymptomatic Diseases studies →Tel Hai College is the lead sponsor of 18 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
33 Healthy men at the age between 20-50 years. 16 normal weight men and 17 obese men.
Exclusion Criteria:
Caffeine capsule (200 mg) is taken prior to RMR measurement
Dietary Supplement: Caffeine · Dietary Supplement: Placebo · Other: Coffee · Other: Decaffeinated
Placebo (starch) capsule is taken prior to RMR measurement
Dietary Supplement: Caffeine · Dietary Supplement: Placebo · Other: Coffee · Other: Decaffeinated
Black coffee (9 grams) is consumed prior to RMR measurement
Dietary Supplement: Caffeine · Dietary Supplement: Placebo · Other: Coffee · Other: Decaffeinated
Decaffeinated Black coffee (9 grams) is consumed prior to RMR measurement
Dietary Supplement: Caffeine · Dietary Supplement: Placebo
200 mg of caffeine capsule before RMR measurement
Placebo capsule (starch) before RMR measurement
9 grams of black coffee in boiling water consumed before RMR measurement
9 grams of decaffeinated black coffee in boiling water consumed before RMR measurement
Measurement of resting metabolic expenditure using indirect calorimetry (open flow canopy system)
Time frame: Within two weeks (4 sessions, each 30 minutes)
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Tel Hai College