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Effect of Two Alcohol-free Beers With Different Carbohydrates Composition on Lipids and Glucose Metabolism

NCT03337828 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-11-09

No results posted yet for this study

Summary

This a controlled, double-blind, randomized, cross designed study to determine the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, comparing to an alcohol-free beer with regular composition, on glycemic metabolism (glucose, glycated hemoglobin, insulin and HOMA index) in subjects with recently diagnosed diabetes mellitus and overweight or obesity. 44 subjects were randomized to consume for 10 weeks: a) two alcohol-free beers with regular carbohydrates composition per day; b) two alcohol-free beers with modified carbohydrates composition per day. Those subjects randomized to begin with A beer during 10 weeks will change to B beer during the second phase for 10 weeks and vice versa. There is a 4-8 weeks wash-out period between two phases.

Conditions

  • Glucose Metabolism Disorders (Including Diabetes Mellitus)
  • Overweight and Obesity

Interventions

OTHER

Alcohol-free beer with regular composition

Subjects are provided with 2 alcohol-free beers with regular carbohydrates composition per day and healthy diet counselling during 10 weeks.

OTHER

Alcohol-free beer with modified composition

Subjects are provided with 2 alcohol-free beers with modified carbohydrates composition per day and healthy diet counselling during 10 weeks.

Sponsors & Collaborators

  • Aragon Institute of Health Sciences

    collaborator OTHER

  • Instituto Aragones de Ciencias de la Salud

    lead OTHER_GOV

Principal Investigators

  • Rocio Mateo-Gallego, RD, PhD · Aragon Institute of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03337828 on ClinicalTrials.gov