AzTrials
AzTrials

Asymptomatic ConditionsPhase 3RMRNCT02751840

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

A Phase 3 study testing Caffeine, Coffee and Decaffeinated in people with Asymptomatic Conditions, run by Tel Hai College.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 20 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Asymptomatic Conditions
What is being tested?
Caffeine, Coffee and Decaffeinated
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
No sites listed yet
Study dates
Oct 2014to Apr 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

About this study

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)

Read more

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.

Read the 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).

Being tested
Caffeine, Placebo, Coffee, Decaffeinated
Medical subject headings
Asymptomatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaffeineDietary supplement

    200 mg of caffeine capsule before RMR measurement

  • PlaceboDietary supplement

    Placebo capsule (starch) before RMR measurement

  • CoffeeOther

    9 grams of black coffee in boiling water consumed before RMR measurement

  • DecaffeinatedOther

    9 grams of decaffeinated black coffee in boiling water consumed before RMR measurement

Study groups in NCT02751840
Study groupRoleWhat they receive
CaffeineExperimentalCaffeine capsule (200 mg) is taken prior to RMR measurement
Receives: Dietary Supplement: Caffeine; Dietary Supplement: Placebo; Other: Coffee; Other: Decaffeinated
PlaceboPlacebo comparatorPlacebo (starch) capsule is taken prior to RMR measurement
Receives: Dietary Supplement: Caffeine; Dietary Supplement: Placebo; Other: Coffee; Other: Decaffeinated
CoffeeExperimentalBlack coffee (9 grams) is consumed prior to RMR measurement
Receives: Dietary Supplement: Caffeine; Dietary Supplement: Placebo; Other: Coffee; Other: Decaffeinated
DecaffeinatedPlacebo comparatorDecaffeinated Black coffee (9 grams) is consumed prior to RMR measurement
Receives: Dietary Supplement: Caffeine; Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of resting metabolic expenditure using indirect calorimetry (open flow canopy system)

    Measured: Within two weeks (4 sessions, each 30 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2016 (estimated)
  2. Study startOct 2014
  3. Primary completionAug 2015
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02751840
Sponsor's protocol ID
Tel Hai College RMR-011
Acronym
RMR
Status last verified
Apr 2016
First submitted
21 Apr 2016
Last updated
27 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Acheson KJ, Zahorska-Markiewicz B, Pittet P, Anantharaman K, Jequier E. Caffeine and coffee: their influence on metabolic rate and substrate utilization in normal weight and obese individuals. Am J Clin Nutr. 1980 May;33(5):989-97. doi: 10.1093/ajcn/33.5.989.

    PubMed 7369170

  • Adan A, Prat G, Fabbri M, Sanchez-Turet M. Early effects of caffeinated and decaffeinated coffee on subjective state and gender differences. Prog Neuropsychopharmacol Biol Psychiatry. 2008 Oct 1;32(7):1698-703. doi: 10.1016/j.pnpbp.2008.07.005. Epub 2008 Jul 15.

    PubMed 18675877

  • Bracco D, Ferrarra JM, Arnaud MJ, Jequier E, Schutz Y. Effects of caffeine on energy metabolism, heart rate, and methylxanthine metabolism in lean and obese women. Am J Physiol. 1995 Oct;269(4 Pt 1):E671-8. doi: 10.1152/ajpendo.1995.269.4.E671.

    PubMed 7485480

  • Jeukendrup AE, Randell R. Fat burners: nutrition supplements that increase fat metabolism. Obes Rev. 2011 Oct;12(10):841-51. doi: 10.1111/j.1467-789X.2011.00908.x.

    PubMed 21951331

  • Temple JL, Ziegler AM. Gender Differences in Subjective and Physiological Responses to Caffeine and the Role of Steroid Hormones. J Caffeine Res. 2011 Mar;1(1):41-48. doi: 10.1089/jcr.2011.0005.

    PubMed 24761262

  • Pohanka M. The perspective of caffeine and caffeine derived compounds in therapy. Bratisl Lek Listy. 2015;116(9):520-30. doi: 10.4149/bll_2015_106.

    PubMed 26435014

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Caffeine, Coffee and Decaffeinated in people with Asymptomatic Conditions, run by Tel Hai College.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of resting metabolic expenditure using indirect calorimetry (open flow canopy system) (time frame: Within two weeks (4 sessions, each 30 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02751840, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in