NCT02099929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

1.5 years

First QC Date

March 26, 2014

Last Update Submit

March 26, 2014

Conditions

Healthy

Keywords

CoffeeGlucoseInsulinDiabetesType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (5)

Coffee with Sugar

EXPERIMENTAL

300mL of Coffee with 30g of Sugar

Other: Coffee with Sugar

Coffee without Sugar

EXPERIMENTAL

300mL of Coffee without Sugar

Other: Coffee without Sugar

Decaffeinated Coffee without Sugar

EXPERIMENTAL

300mL of Decaffeinated Coffee without Sugar

Other: Decaffeinated Coffee without Sugar

Water with Sugar

SHAM COMPARATOR

300mL of Water with 30g of Sugar

Other: Water with Sugar

Water without Sugar

SHAM COMPARATOR

300mL of Water without Sugar

Other: Water without Sugar

Interventions

Coffee with SugarOTHER

300mL of Coffee with 30g of Sugar

Coffee with Sugar
Coffee without SugarOTHER

300mL of Coffee without Sugar

Coffee without Sugar
Decaffeinated Coffee without SugarOTHER

300mL of Decaffeinated Coffee without Sugar

Decaffeinated Coffee without Sugar
Water with SugarOTHER

300mL of Water with 30g of Sugar

Water with Sugar
Water without SugarOTHER

300mL of Water without Sugar

Water without Sugar

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Brasília, Federal District, 70910-900, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 16402351BACKGROUND

MeSH Terms

Conditions

Insulin ResistanceDiabetes MellitusDiabetes Mellitus, Type 2

Interventions

CoffeeSugarsWater

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesCarbohydratesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Leslie JC Bluck, PhD

    MRC Human Nutrition Research

    STUDY CHAIR

  • Teresa HM da Costa, PhD

    University of Brasilia

    STUDY DIRECTOR

  • Caio EG Reis, MSc

    University of Brasilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2014

First Posted

March 31, 2014

Study Start

June 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

BR(1)