Effects of Coffee Consumption on Glucose Metabolism

Healthy Clinical Trial

Official title:

Coffee and Glucose Metabolism: Clinical, Crossover and Randomized Glucose Disposal Assay Using Stable Isotopes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099929
• Other study ID #: GliCafé
• Status: Completed
• Phase: N/A
• First received: March 26, 2014
• Last updated: March 26, 2014
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Coffee with Sugar
300mL of Coffee with 30g of Sugar
• Coffee without Sugar
300mL of Coffee without Sugar
• Decaffeinated Coffee without Sugar
300mL of Decaffeinated Coffee without Sugar
• Water with Sugar
300mL of Water with 30g of Sugar
• Water without Sugar
300mL of Water without Sugar

Locations

Country	Name	City	State
Brazil	Laboratório de Bioquímica da Nutrição, Núcleo de Nutrição e Medicina Tropical, Universidade de Brasília	Brasília	DF

Sponsors (3)

Lead Sponsor	Collaborator
University of Brasilia	Conselho Nacional de Desenvolvimento Científico e Tecnológico, MRC Human Nutrition Research (UK)

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Bluck LJ, Clapperton AT, Coward WA. A stable isotope minimal model protocol with oral glucose administration. Rapid Commun Mass Spectrom. 2006;20(3):493-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ODILE minimal model analysis	The stable isotope minimal model protocol with oral glucose administration (Oral Dose Intravenous Label Experiment - ODILE)	-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.	No
Secondary	Glucose metabolism	Glucose and Insulin levels, and Insulin sensitivity indices.	-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.	No