NCT02751840

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) (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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

10 months

First QC Date

April 21, 2016

Last Update Submit

April 26, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Within two weeks (4 sessions, each 30 minutes)

Study Arms (4)

Caffeine

EXPERIMENTAL

Caffeine capsule (200 mg) is taken prior to RMR measurement

Dietary Supplement: CaffeineDietary Supplement: PlaceboOther: CoffeeOther: Decaffeinated

Placebo

PLACEBO COMPARATOR

Placebo (starch) capsule is taken prior to RMR measurement

Dietary Supplement: CaffeineDietary Supplement: PlaceboOther: CoffeeOther: Decaffeinated

Coffee

EXPERIMENTAL

Black coffee (9 grams) is consumed prior to RMR measurement

Dietary Supplement: CaffeineDietary Supplement: PlaceboOther: CoffeeOther: Decaffeinated

Decaffeinated

PLACEBO COMPARATOR

Decaffeinated Black coffee (9 grams) is consumed prior to RMR measurement

Dietary Supplement: CaffeineDietary Supplement: Placebo

Interventions

CaffeineDIETARY_SUPPLEMENT

200 mg of caffeine capsule before RMR measurement

CaffeineCoffeeDecaffeinatedPlacebo
PlaceboDIETARY_SUPPLEMENT

Placebo capsule (starch) before RMR measurement

CaffeineCoffeeDecaffeinatedPlacebo
CoffeeOTHER

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

CaffeineCoffeePlacebo

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

CaffeineCoffeePlacebo

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 7369170BACKGROUND
  • 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.

    PMID: 18675877BACKGROUND
  • 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.

    PMID: 7485480BACKGROUND
  • 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.

    PMID: 21951331BACKGROUND
  • 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.

    PMID: 24761262BACKGROUND
  • 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.

    PMID: 26435014BACKGROUND

MeSH Terms

Conditions

Asymptomatic Diseases

Interventions

CaffeineCoffee

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPlant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2016

First Posted

April 26, 2016

Study Start

October 1, 2014

Primary Completion

August 1, 2015

Study Completion

April 1, 2016

Last Updated

April 27, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share