Effects of Caffeine and Coffee on Resting Metabolic Rate, Comparing Normal Weight Men to Obese Men (RMR)

April 26, 2016 updated by: Tel Hai College

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 0.05 . standard deviation (SD).

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

33 Healthy men at the age between 20-50 years. 16 normal weight men and 17 obese men.

Exclusion Criteria:

  1. Hypertension (above 140/90 mmHg)
  2. Taking medications for hypertension
  3. Heart, liver or kidney problems, diabetes, respiratory problems, hypo/hyper thyroidism.
  4. Smoking
  5. Men who consume caffeine above 400 mg/day
  6. Taking medications or dietary supplements that can affect energy expenditure
  7. Elite athletes (competitive sport)
  8. Night Eating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caffeine
Caffeine capsule (200 mg) is taken prior to RMR measurement
Dietary supplement: Caffeine
200 mg of caffeine capsule before RMR measurement
Dietary supplement: Placebo
Placebo capsule (starch) before RMR measurement
Other: Coffee
9 grams of black coffee in boiling water consumed before RMR measurement
Other: Decaffeinated
9 grams of decaffeinated black coffee in boiling water consumed before RMR measurement
Placebo Comparator: Placebo
Placebo (starch) capsule is taken prior to RMR measurement
Dietary supplement: Caffeine
200 mg of caffeine capsule before RMR measurement
Dietary supplement: Placebo
Placebo capsule (starch) before RMR measurement
Other: Coffee
9 grams of black coffee in boiling water consumed before RMR measurement
Other: Decaffeinated
9 grams of decaffeinated black coffee in boiling water consumed before RMR measurement
Experimental: Coffee
Black coffee (9 grams) is consumed prior to RMR measurement
Dietary supplement: Caffeine
200 mg of caffeine capsule before RMR measurement
Dietary supplement: Placebo
Placebo capsule (starch) before RMR measurement
Other: Coffee
9 grams of black coffee in boiling water consumed before RMR measurement
Other: Decaffeinated
9 grams of decaffeinated black coffee in boiling water consumed before RMR measurement
Placebo Comparator: Decaffeinated
Decaffeinated Black coffee (9 grams) is consumed prior to RMR measurement
Dietary supplement: Caffeine
200 mg of caffeine capsule before RMR measurement
Dietary supplement: Placebo
Placebo capsule (starch) before RMR measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of resting metabolic expenditure using indirect calorimetry (open flow canopy system)
Time Frame: Within two weeks (4 sessions, each 30 minutes)
Within two weeks (4 sessions, each 30 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel Hai College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimate)

April 26, 2016

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tel Hai College RMR-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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