Viewing Study NCT02751840



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Last Modification Date: 2024-10-26 @ 12:01 PM
Study NCT ID: NCT02751840
Status: COMPLETED
Last Update Posted: 2016-04-27
First Post: 2016-04-21

Brief Title: Effects of Caffeine and Coffee on Resting Metabolic Rate Comparing Normal Weight Men to Obese Men
Sponsor: Tel Hai College
Organization: Tel Hai College

Study Overview

Official Title: Effects of Caffeine and Coffee on Resting Metabolic Rate Comparing Normal Weight Men to Obese Men
Status: COMPLETED
Status Verified Date: 2016-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: RMR
Brief Summary: 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 VCO2VO2 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
Detailed Description: 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 005 standard deviation SD

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None