Effects of Coffee Consumption on Glucose Metabolism

NCT ID: NCT02099929

Last Updated: 2014-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-12-31

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).

Conditions

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Healthy

Keywords

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Coffee Glucose Insulin Diabetes Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Coffee with Sugar

300mL of Coffee with 30g of Sugar

Group Type EXPERIMENTAL

Coffee with Sugar

Intervention Type OTHER

300mL of Coffee with 30g of Sugar

Coffee without Sugar

300mL of Coffee without Sugar

Group Type EXPERIMENTAL

Coffee without Sugar

Intervention Type OTHER

300mL of Coffee without Sugar

Decaffeinated Coffee without Sugar

300mL of Decaffeinated Coffee without Sugar

Group Type EXPERIMENTAL

Decaffeinated Coffee without Sugar

Intervention Type OTHER

300mL of Decaffeinated Coffee without Sugar

Water with Sugar

300mL of Water with 30g of Sugar

Group Type SHAM_COMPARATOR

Water with Sugar

Intervention Type OTHER

300mL of Water with 30g of Sugar

Water without Sugar

300mL of Water without Sugar

Group Type SHAM_COMPARATOR

Water without Sugar

Intervention Type OTHER

300mL of Water without Sugar

Interventions

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Coffee with Sugar

300mL of Coffee with 30g of Sugar

Intervention Type OTHER

Coffee without Sugar

300mL of Coffee without Sugar

Intervention Type OTHER

Decaffeinated Coffee without Sugar

300mL of Decaffeinated Coffee without Sugar

Intervention Type OTHER

Water with Sugar

300mL of Water with 30g of Sugar

Intervention Type OTHER

Water without Sugar

300mL of Water without Sugar

Intervention Type OTHER

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

MRC Human Nutrition Research

OTHER_GOV

Sponsor Role collaborator

University of Brasilia

OTHER

Sponsor Role lead

Responsible Party

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Caio Eduardo Gonçalves Reis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leslie JC Bluck, PhD

Role: STUDY_CHAIR

MRC Human Nutrition Research

Teresa HM da Costa, PhD

Role: STUDY_DIRECTOR

University of Brasilia

Caio EG Reis, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Brasilia

Locations

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Laboratório de Bioquímica da Nutrição, Núcleo de Nutrição e Medicina Tropical, Universidade de Brasília

Brasília, Federal District, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 16402351 (View on PubMed)

Other Identifiers

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GliCafé

Identifier Type: -

Identifier Source: org_study_id