Clinical trial NCT02099929: Effects of Coffee Consumption on Glucose Metabolism
Official title: Coffee and Glucose Metabolism: Clinical, Crossover and Randomized Glucose Disposal Assay Using Stable Isotopes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Coffee
Glucose
Insulin
Diabetes
Type 2 Diabetes Mellitus
Lead sponsor: University of Brasilia
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: MRC Human Nutrition Research
First posted: 2014-03-31
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).

Eligibility 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).

Primary outcomes:
measure: ODILE minimal model analysis
timeFrame: -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 outcomes:
measure: Glucose metabolism
timeFrame: -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.
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Laboratório de Bioquímica da Nutrição, Núcleo de Nutrição e Medicina Tropical, Universidade de Brasília
state: DF
Study officials:
affiliation: MRC Human Nutrition Research
name: Leslie JC Bluck, PhD
role: STUDY_CHAIR
affiliation: University of Brasilia
name: Teresa HM da Costa, PhD
role: STUDY_DIRECTOR
affiliation: University of Brasilia
name: Caio EG Reis, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1002/rcm.2326.