Effects of Coffee Consumption on Glucose Metabolism

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Coffee with Sugar; Other: Coffee without Sugar; Other: Decaffeinated Coffee without Sugar; Other: Water with Sugar; Other: Water without Sugar

• Registration Number: NCT02099929
• Lead Sponsor: 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.

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).

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-03
• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-03-26
• Last Update Submitted: 2014-03-26
• Study First Posted: 2014-03-31
• Last Update Posted: 2014-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Coffee with Sugar	Coffee with Sugar	300mL of Coffee with 30g of Sugar
Coffee without Sugar	Coffee without Sugar	300mL of Coffee without Sugar
Decaffeinated Coffee without Sugar	Decaffeinated Coffee without Sugar	300mL of Decaffeinated Coffee without Sugar
Water with Sugar	Water with Sugar	300mL of Water with 30g of Sugar
Water without Sugar	Water without Sugar	300mL of Water without Sugar

Primary Outcome Measures

Name	Time	Method
ODILE minimal model analysis	-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

Name	Time	Method
Glucose metabolism	-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.

Trial Locations

Locations (1)

Laboratório de Bioquímica da Nutrição, Núcleo de Nutrição e Medicina Tropical, Universidade de Brasília; 🇧🇷 Brasília, DF, Brazil