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Completed

NCT Number: NCT02099929

Effects of Coffee Consumption on Glucose Metabolism

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Brasília, Federal District, 70910-900, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Coffee with Sugar

Other

300mL of Coffee with 30g of Sugar

Coffee without Sugar

Other

300mL of Coffee without Sugar

Decaffeinated Coffee without Sugar

Other

300mL of Decaffeinated Coffee without Sugar

Water with Sugar

Other

300mL of Water with 30g of Sugar

Water without Sugar

Other

300mL of Water without Sugar

Primary outcomes

  1. ODILE minimal model analysis

    Time frame: -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 outcomes

  1. Glucose metabolism

    Time frame: -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.

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • MRC Human Nutrition Research

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 31, 2014
Registry last updated
Mar 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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