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

NCT03337828 | Unknown

• 1 other identifier: CEICA PI16/0277
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Alcohol-free beer; Carbohydrates; Overweight; Obesity; Diabetes mellitus type 2; Microbiota; Glucose metabolism

Outcome Measures

Primary Outcomes (4)

• Glucose concentration change after each alcohol-free beer phase.

  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.

  10 weeks

• Glycated hemoglobin concentration change after each alcohol-free beer phase.

  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.

  10 weeks

• Insulin concentration change after each alcohol-free beer phase.

  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.

  10 weeks

• Homeostatic model assessment (HOMA) index change after each alcohol-free beer phase.

  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.

  10 weeks

Secondary Outcomes (4)

• Lipid profile change after each alcohol-free beer phase.

  10 weeks

• Body weight change after each alcohol-free beer phase.

  10 weeks

• C reactive protein concentration change after each alcohol-free beer phase.

  10 weeks

• Micriobota change after each alcohol-free beer phase.

  10 weeks

Study Arms (2)

Alcohol-free beer with regular composition

ACTIVE COMPARATOR

Two cans (33 cl.) per day of an alcohol-free beer with regular carbohydrates composition.

Other: Alcohol-free beer with regular composition

Alcohol-free beer with modified composition

EXPERIMENTAL

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

Interventions

Alcohol-free beer with regular composition OTHER

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

Alcohol-free beer with regular composition

Alcohol-free beer with modified composition OTHER

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

Alcohol-free beer with modified composition

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Instituto Aragones de Ciencias de la Salud: lead
• Aragon Institute of Health Sciences: collaborator

Study Sites (1)

Fernando Civeira

Zaragoza, 50009, Spain

Location

Related Publications (2)

• Mateo-Gallego R , Moreno-Indias I , Bea AM , Sanchez-Alcoholado L , Fumanal AJ , Quesada-Molina M , Prieto-Martin A , Gutierrez-Repiso C , Civeira F , Tinahones FJ . An alcohol-free beer enriched with isomaltulose and a resistant dextrin modulates gut microbiome in subjects with type 2 diabetes mellitus and overweight or obesity: a pilot study. Food Funct. 2021 Apr 21;12(8):3635-3646. doi: 10.1039/d0fo03160g. Epub 2021 Mar 31.

  PMID: 33900319 DERIVED

• Mateo-Gallego R, Perez-Calahorra S, Lamiquiz-Moneo I, Marco-Benedi V, Bea AM, Fumanal AJ, Prieto-Martin A, Laclaustra M, Cenarro A, Civeira F. Effect of an alcohol-free beer enriched with isomaltulose and a resistant dextrin on insulin resistance in diabetic patients with overweight or obesity. Clin Nutr. 2020 Feb;39(2):475-483. doi: 10.1016/j.clnu.2019.02.025. Epub 2019 Mar 5.

  PMID: 30879735 DERIVED

MeSH Terms

Conditions

Glucose Metabolism Disorders; Overweight; Obesity; Diabetes Mellitus, Type 2

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Rocio Mateo-Gallego, RD, PhD

  Aragon Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 9, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Locations

ES (1)