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Trial record 18 of 77 for:    coffee

Effects of Coffee Consumption on Glucose Metabolism

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ClinicalTrials.gov Identifier: NCT02099929
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : March 31, 2014
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
MRC Human Nutrition Research
Information provided by (Responsible Party):
Caio Eduardo Gonçalves Reis, University of Brasilia

Brief Summary:

Epidemiological studies have shown an inverse association between coffee consumption and risk of type 2 diabetes mellitus (T2DM). However the experimental studies that analysed the mechanisms are limited.

This project aims to assess the effects of coffee consumption on glucose metabolism, using stable isotope tracer (13C-glucose) to explain the possible metabolic mechanisms involved on the reduced risk for T2DM.


Condition or disease Intervention/treatment Phase
Healthy Other: Coffee with Sugar Other: Coffee without Sugar Other: Decaffeinated Coffee without Sugar Other: Water with Sugar Other: Water without Sugar Not Applicable

Detailed Description:

This is a crossover randomized clinical trial that has been studying 14 male healthy young adults, who were enrolled five treatments: coffee with sugar, coffee without sugar, decaffeinated coffee without sugar and two controls (water with and without sugar).

The stable isotope minimal model protocol with oral glucose administration (Oral Dose Intravenous Label Experiment - ODILE) was performed. The use of ODILE methodology permits separation of the glucose absorbed and removed from the circulation increasing the accuracy and the effectiveness of glucose uptake and insulin sensitivity (Bluck et al., 2006).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Coffee and Glucose Metabolism: Clinical, Crossover and Randomized Glucose Disposal Assay Using Stable Isotopes
Study Start Date : June 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: Coffee with Sugar
300mL of Coffee with 30g of Sugar
Other: Coffee with Sugar
300mL of Coffee with 30g of Sugar

Experimental: Coffee without Sugar
300mL of Coffee without Sugar
Other: Coffee without Sugar
300mL of Coffee without Sugar

Experimental: Decaffeinated Coffee without Sugar
300mL of Decaffeinated Coffee without Sugar
Other: Decaffeinated Coffee without Sugar
300mL of Decaffeinated Coffee without Sugar

Sham Comparator: Water with Sugar
300mL of Water with 30g of Sugar
Other: Water with Sugar
300mL of Water with 30g of Sugar

Sham Comparator: Water without Sugar
300mL of Water without Sugar
Other: Water without Sugar
300mL of Water without Sugar




Primary Outcome Measures :
  1. ODILE minimal model analysis [ Time Frame: -10, 0, 30, 60/0, 15, 30, 45, 47, 49, 51, 53, 55, 57, 59, 61, 65, 70, 75, 80, 85, 90, 100, 115, 135, 165, 195, 225 minutes. ]
    The stable isotope minimal model protocol with oral glucose administration (Oral Dose Intravenous Label Experiment - ODILE)


Secondary Outcome Measures :
  1. Glucose metabolism [ Time Frame: -10, 0, 30, 60/0, 15, 30, 45, 47, 49, 51, 53, 55, 57, 59, 61, 65, 70, 75, 80, 85, 90, 100, 115, 135, 165, 195, 225 minutes. ]
    Glucose and Insulin levels, and Insulin sensitivity indices.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male healthy young adults (18 - 50 years old);
  • Body mass index (BMI) between 18.5 - 28.0 kg/m²;
  • No weight changes (≥ 5 kg) in the last 3 months;
  • Not take any pills/drugs that alter metabolism, appetite and sleep;
  • Not have sleep disorders;
  • Not have donated blood in the last 3 months;
  • Regular breakfast consumption (≥100 kcal ingested up to 2 hours after waking ≥4x/week);
  • Being a habitual coffee consumer (≥100mL ≥5x/week).

Exclusion Criteria:

  • Diagnosis of anemia, metabolic and heart diseases;
  • Previous sudden fainting and convulsions;
  • Any drugs and tobacco consumption;
  • Consumption of more than 500mg of caffeine / day (5 cups of coffee, tea and cola soft drinks).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099929


Locations
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Brazil
Laboratório de Bioquímica da Nutrição, Núcleo de Nutrição e Medicina Tropical, Universidade de Brasília
Brasília, DF, Brazil, 70910-900
Sponsors and Collaborators
University of Brasilia
Conselho Nacional de Desenvolvimento Científico e Tecnológico
MRC Human Nutrition Research
Investigators
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Study Chair: Leslie JC Bluck, PhD MRC Human Nutrition Research
Study Director: Teresa HM da Costa, PhD University of Brasilia
Principal Investigator: Caio EG Reis, MSc University of Brasilia

Publications:
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Responsible Party: Caio Eduardo Gonçalves Reis, Principal Investigator, University of Brasilia
ClinicalTrials.gov Identifier: NCT02099929     History of Changes
Other Study ID Numbers: GliCafé
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014

Keywords provided by Caio Eduardo Gonçalves Reis, University of Brasilia:
Coffee
Glucose
Insulin
Diabetes
Type 2 Diabetes Mellitus