Effects of Coffee Consumption on Glucose Metabolism

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Coffee with Sugar
* Other: Coffee without Sugar
* Other: Decaffeinated Coffee without Sugar
* Other: Water with Sugar
* Other: Water without Sugar


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coffee with Sugar<br>300mL of Coffee with 30g of Sugar | Other: Coffee with Sugar<br>* 300mL of Coffee with 30g of Sugar<br>|
| Experimental: Coffee without Sugar<br>300mL of Coffee without Sugar | Other: Coffee without Sugar<br>* 300mL of Coffee without Sugar<br>|
| Experimental: Decaffeinated Coffee without Sugar<br>300mL of Decaffeinated Coffee without Sugar | Other: Decaffeinated Coffee without Sugar<br>* 300mL of Decaffeinated Coffee without Sugar<br>|
| Sham Comparator: Water with Sugar<br>300mL of Water with 30g of Sugar | Other: Water with Sugar<br>* 300mL of Water with 30g of Sugar<br>|
| Sham Comparator: Water without Sugar<br>300mL of Water without Sugar | Other: Water without Sugar<br>* 300mL of Water without Sugar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coffee, Glucose, Insulin, Diabetes, Type 2 Diabetes Mellitus