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

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ClinicalTrials.gov Identifier: NCT03337828
Recruitment Status : Active, not recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
Aragon Institute of Health Sciences
Information provided by (Responsible Party):
Fernando Civeira, Aragon Institute of Health Sciences

Brief 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.

Condition or disease Intervention/treatment
Glucose Metabolism Disorders (Including Diabetes Mellitus) Overweight and Obesity Other: Alcohol-free beer with regular composition Other: Alcohol-free beer with modified composition

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Cross-over Study Comparing the Effect of Two Alcohol-free Beers With Different Carbohydrates Composition on Lipid and Glycemic Metabolism in Subjects With Prediabetes and Recently Diagnosed Diabetes and Overweight or Obesity
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Alcohol-free beer with regular composition
Two cans (33 cl.) per day of an alcohol-free beer with regular carbohydrates composition.
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.
Experimental: Alcohol-free beer with modified composition
Two cans (33 cl.) per day of alcohol-free beer with modified carbohydrates composition. This include the substitution of regular maltose by isomaltulose and the addition of maltodextrin (fiber).
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.



Primary Outcome Measures :
  1. Glucose concentration change after each alcohol-free beer phase. [ Time Frame: 10 weeks ]
    Main objective is 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 glucose concentration change.

  2. Glycated hemoglobin concentration change after each alcohol-free beer phase. [ Time Frame: 10 weeks ]
    Main objective is 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 glycated hemoglobin concentration change.

  3. Insulin concentration change after each alcohol-free beer phase. [ Time Frame: 10 weeks ]
    Main objective is 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 insulin concentration change.

  4. Homeostatic model assessment (HOMA) index change after each alcohol-free beer phase. [ Time Frame: 10 weeks ]
    Main objective is 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 HOMA index change.


Secondary Outcome Measures :
  1. Lipid profile change after each alcohol-free beer phase. [ Time Frame: 10 weeks ]
    Secondary objective involves determining 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 LDL cholesterol concentration change.

  2. Body weight change after each alcohol-free beer phase. [ Time Frame: 10 weeks ]
    Secondary objective involves determining 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 body weight.

  3. C reactive protein concentration change after each alcohol-free beer phase. [ Time Frame: 10 weeks ]
    Secondary objective involves determining 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 C reactive protein change.

  4. Micriobota change after each alcohol-free beer phase. [ Time Frame: 10 weeks ]
    Secondary objective involves determining 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 microbiota.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 18 and 80 years.
  • To provide informed consent in writing of voluntary participation in the study after having read the participant information sheet, and having consulted the doubts that may arise from it.
  • Diagnosis of prediabetes or diabetes mellitus type 2 defined as: a) fasting glucose ≥ 100 mg/dL in the last 3 months; b) glycated hemoglobin ≥ 5.7% and ≤ 6.5%.

Exclusion Criteria:

  • Gluten intolerance.
  • Taking lipid-lowering drugs.
  • Taking antidiabetic drugs, except for metformin in a stable dose in the last 3 months.
  • To be under treatment with insulin.
  • Presence of uncontrolled endocrinological disease by including hypothyroidism.
  • Regular intake of functional foods with plant sterols in the past 6 weeks.
  • Intake of vitamin supplements.
  • Hormone replacement therapy.
  • High intake of alcohol (> 30 g ethanol) on a regular basis.
  • Pregnancy or intention of pregnancy during the study since the proposed nutritional intervention may not be suitable for this situation.
  • Serious illness of any type with less than 1-year life expectancy or if, in the opinion of the investigators, it would limit a stable diet throughout the study.
  • To be under treatment with corticosteroids, hormonal treatment or antibiotics the 3 months prior to randomization.
  • To take prebiotics, probiotics, vitamin supplements and any other drug that could influence the intestinal microbiota, in the 3 months prior to randomization.
  • Any other circumstances which, according to researcher's assessment, could interfere with the correct development of nutritional intervention (e.g.: frequent trips during the study, failure to attend visits by personal or business circumstances, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337828


Locations
Spain
Fernando Civeira
Zaragoza, Spain, 50009
Sponsors and Collaborators
Instituto Aragones de Ciencias de la Salud
Aragon Institute of Health Sciences
Investigators
Principal Investigator: Rocio Mateo-Gallego, RD, PhD Aragon Institute of Health Sciences
  Study Documents (Full-Text)

Documents provided by Fernando Civeira, Aragon Institute of Health Sciences:

Responsible Party: Fernando Civeira, Professor of Medicine, Aragon Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT03337828     History of Changes
Other Study ID Numbers: CEICA PI16/0277
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fernando Civeira, Aragon Institute of Health Sciences:
Alcohol-free beer
Carbohydrates
Overweight
Obesity
Diabetes mellitus type 2
Microbiota
Glucose metabolism

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Overweight
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs