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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02751840
Other study ID # Tel Hai College RMR-011
Secondary ID
Status Completed
Phase Phase 3
First received April 21, 2016
Last updated April 26, 2016
Start date October 2014
Est. completion date April 2016

Study information

Verified date April 2016
Source Tel Hai College
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical 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). 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date April 2016
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Caffeine
200 mg of caffeine capsule before RMR measurement
Placebo
Placebo capsule (starch) before RMR measurement
Other:
Coffee
9 grams of black coffee in boiling water consumed before RMR measurement
Decaffeinated
9 grams of decaffeinated black coffee in boiling water consumed before RMR measurement

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tel Hai College

References & Publications (6)

Acheson KJ, Zahorska-Markiewicz B, Pittet P, Anantharaman K, Jéquier 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. — View Citation

Adan A, Prat G, Fabbri M, Sànchez-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. — View Citation

Bracco D, Ferrarra JM, Arnaud MJ, Jéquier 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. — View Citation

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. Review. — View Citation

Pohanka M. The perspective of caffeine and caffeine derived compounds in therapy. Bratisl Lek Listy. 2015;116(9):520-30. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of resting metabolic expenditure using indirect calorimetry (open flow canopy system) Within two weeks (4 sessions, each 30 minutes) No
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