Effect of the Consumption of Alcohol-free Beers With Different Carbohydrates Composition on Postprandial Metabolic Response

September 29, 2021 updated by: Rocio Mateo-Gallego, Universidad de Zaragoza
The overall objective of this study is to explore the glycemic index and glycemic load induced by an alcohol-free beer with modified composition (including almost full fermentation of carbohydrates and the addition of isomaltulose and a resistant maltodextrin), as well as its postprandial metabolic response, compared to the effect induced by: a) an alcohol-free beer with a usual composition; b) an alcohol-free beer with modified composition (including almost full fermentation of carbohydrates and the addition of a resistant maltodextrin). This study includes two cross-over sub-studies recruiting healthy participants. In the first one, 10 healthy volunteers receive 25 g of carbohydrates coming from: regular alcohol-free beer (RB), alcohol-free beer with almost completely eliminated maltose and enriched with isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB), alcohol-free beer with the same maltose removal enriched with resistant maltodextrin (2.0 g/100 mL) (MB) and glucose solution. In the second study, 20 healthy volunteers are provided with 50 g of carbohydrates from white bread and water and the same meal plus 14.3 g of carbohydrates coming from: RB, IMB, MB and extra white bread. Blood is sampled at baseline and for 2 h, every 15 min, after ingestion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI between 18.5 and 27.5 kg/m2.

Exclusion Criteria:

  • Presence of cardiometabolic pathology such as dyslipemia (total cholesterol > 200 mg/dL and/or triglycerides > 150 mg/dL, and/or taking lipid-lowering drugs), prediabetes or type 1 or 2 diabetes mellitus (glucose ≥ 100 mg/dL and/or glycosylated hemoglobin ≥ 5.7% and/or taking hypoglycemic drugs) or high blood pressure without drug treatment.
  • Presence of other chronic pathologies that could interfere with the results of the study such as cardiovascular disease, kidney disease, thyroid disease or liver disease.
  • Presence of intestinal malabsorption syndromes and/or presence of Chron disease or ulcerative colitis.
  • Use of drugs that may interfere with lipid and/or glycidic metabolism.
  • Presence of some analytical alteration that could interfere with the results of the study.
  • Increased or decreased body weight of ≥ 5 kg in the last 6 months.
  • Gluten intolerance.
  • Regular intake of functional foods such as phytosterols or red rice yeast, which have a significant effect on lipid or glycidic metabolism, in the last 6 weeks.
  • Intake of vitamin supplements.
  • Hormone replacement therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: First sub-study: Glucose beverage
This intervention entails the intake of a beverage including 25 g of glucose.
Other: Sub-study 1
Subjects were provided with: a) Glucose beverage; b) Regular alcohol-free beer; c) Alcohol-free beer with modified composition (isomaltulose + maltodextrin); d) Alcohol-free beer with modified composition (++ maltodextrin).
Experimental: First sub-study: Regular alcohol-free beer
This intervention entails the intake of regular alcohol-free beer including 25 of carbohydrates.
Other: Sub-study 1
Subjects were provided with: a) Glucose beverage; b) Regular alcohol-free beer; c) Alcohol-free beer with modified composition (isomaltulose + maltodextrin); d) Alcohol-free beer with modified composition (++ maltodextrin).
Experimental: First sub-study: Alcohol-free beer with modified composition (isomaltulose + maltodextrin)
This intervention entails the intake of an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched with isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB). This beverage included 25 g of carbohydrates.
Other: Sub-study 1
Subjects were provided with: a) Glucose beverage; b) Regular alcohol-free beer; c) Alcohol-free beer with modified composition (isomaltulose + maltodextrin); d) Alcohol-free beer with modified composition (++ maltodextrin).
Experimental: First sub-study: Alcohol-free beer with modified composition (++ maltodextrin)
This intervention entails the intake of an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched with a resistant maltodextrin (2.0 g/100 mL) (MB). This beverage included 25 g of carbohydrates.
Other: Sub-study 1
Subjects were provided with: a) Glucose beverage; b) Regular alcohol-free beer; c) Alcohol-free beer with modified composition (isomaltulose + maltodextrin); d) Alcohol-free beer with modified composition (++ maltodextrin).
Active Comparator: Second sub-study: White bread + Water
This intervention entails the intake of white bread (providing 50 g of carbohydrates) and water.
Other: Sub-study 2
Subjects were provided with: a) White bread + Water; b) White bread + Regular alcohol-free beer; c) White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin); d) White bread + Alcohol-free beer enriched with ++ maltodextrin; e) Extra-White bread + Water.
Experimental: Second sub-study: White bread + Regular alcohol-free beer
This intervention entails the intake of white bread (providing 50 g of carbohydrates) and regular alcohol-free beer (providing 14.3 g of carbohydrates).
Other: Sub-study 2
Subjects were provided with: a) White bread + Water; b) White bread + Regular alcohol-free beer; c) White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin); d) White bread + Alcohol-free beer enriched with ++ maltodextrin; e) Extra-White bread + Water.
Experimental: Second sub-study: White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin)
This intervention entails the intake of white bread (providing 50 g of carbohydrates) and an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched with isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB). This beverage included 14.3 g of carbohydrates.
Other: Sub-study 2
Subjects were provided with: a) White bread + Water; b) White bread + Regular alcohol-free beer; c) White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin); d) White bread + Alcohol-free beer enriched with ++ maltodextrin; e) Extra-White bread + Water.
Experimental: Second sub-study: White bread + Alcohol-free beer enriched with ++ maltodextrin
This intervention entails the intake of white bread (providing 50 g of carbohydrates) and an alcohol-free beer with modified composition in which the maltose has been almost completely eliminated and enriched a resistant maltodextrin (2.0 g/100 mL) (MB). This beverage included 14.3 g of carbohydrates.
Other: Sub-study 2
Subjects were provided with: a) White bread + Water; b) White bread + Regular alcohol-free beer; c) White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin); d) White bread + Alcohol-free beer enriched with ++ maltodextrin; e) Extra-White bread + Water.
Active Comparator: Second sub-study: Extra-White bread + Water
This intervention entails the intake of white bread which provides 64.3 g (50 g + 14.3 g) of carbohydrates and water. This intervention would be the comparator in carbohydrates-equally conditions.
Other: Sub-study 2
Subjects were provided with: a) White bread + Water; b) White bread + Regular alcohol-free beer; c) White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin); d) White bread + Alcohol-free beer enriched with ++ maltodextrin; e) Extra-White bread + Water.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Glucose
Time Frame: Change from Baseline to 15-minutes after consumption of the beverage.
Change from Baseline to 15-minutes after consumption of the beverage.
Glucose
Time Frame: Change from Baseline to 30-minutes after consumption of the beverage.
Change from Baseline to 30-minutes after consumption of the beverage.
Glucose
Time Frame: Change from Baseline to 45-minutes after consumption of the beverage.
Change from Baseline to 45-minutes after consumption of the beverage.
Glucose
Time Frame: Change from Baseline to 60-minutes after consumption of the beverage.
Change from Baseline to 60-minutes after consumption of the beverage.
Glucose
Time Frame: Change from Baseline to 75-minutes after consumption of the beverage.
Change from Baseline to 75-minutes after consumption of the beverage.
Glucose
Time Frame: Change from Baseline to 90-minutes after consumption of the beverage.
Change from Baseline to 90-minutes after consumption of the beverage.
Glucose
Time Frame: Change from Baseline to 105-minutes after consumption of the beverage.
Change from Baseline to 105-minutes after consumption of the beverage.
Glucose
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Change from Baseline to 120-minutes after consumption of the beverage.
Insulin
Time Frame: Change from Baseline to 15-minutes after consumption of the beverage.
Change from Baseline to 15-minutes after consumption of the beverage.
Insulin
Time Frame: Change from Baseline to 30-minutes after consumption of the beverage.
Change from Baseline to 30-minutes after consumption of the beverage.
Insulin
Time Frame: Change from Baseline to 45-minutes after consumption of the beverage.
Change from Baseline to 45-minutes after consumption of the beverage.
Insulin
Time Frame: Change from Baseline to 60-minutes after consumption of the beverage.
Change from Baseline to 60-minutes after consumption of the beverage.
Insulin
Time Frame: Change from Baseline to 75-minutes after consumption of the beverage.
Change from Baseline to 75-minutes after consumption of the beverage.
Insulin
Time Frame: Change from Baseline to 90-minutes after consumption of the beverage.
Change from Baseline to 90-minutes after consumption of the beverage.
Insulin
Time Frame: Change from Baseline to 105-minutes after consumption of the beverage.
Change from Baseline to 105-minutes after consumption of the beverage.
Insulin
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Change from Baseline to 120-minutes after consumption of the beverage.
GLP-1
Time Frame: Change from Baseline to 15-minutes after consumption of the beverage.
Change from Baseline to 15-minutes after consumption of the beverage.
GLP-1
Time Frame: Change from Baseline to 30-minutes after consumption of the beverage.
Change from Baseline to 30-minutes after consumption of the beverage.
GLP-1
Time Frame: Change from Baseline to 45-minutes after consumption of the beverage.
Change from Baseline to 45-minutes after consumption of the beverage.
GLP-1
Time Frame: Change from Baseline to 60-minutes after consumption of the beverage.
Change from Baseline to 60-minutes after consumption of the beverage.
GLP-1
Time Frame: Change from Baseline to 75-minutes after consumption of the beverage.
Change from Baseline to 75-minutes after consumption of the beverage.
GLP-1
Time Frame: Change from Baseline to 90-minutes after consumption of the beverage.
Change from Baseline to 90-minutes after consumption of the beverage.
GLP-1
Time Frame: Change from Baseline to 105-minutes after consumption of the beverage.
Change from Baseline to 105-minutes after consumption of the beverage.
GLP-1
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Change from Baseline to 120-minutes after consumption of the beverage.
GIP
Time Frame: Change from Baseline to 15-minutes after consumption of the beverage.
Change from Baseline to 15-minutes after consumption of the beverage.
GIP
Time Frame: Change from Baseline to 30-minutes after consumption of the beverage.
Change from Baseline to 30-minutes after consumption of the beverage.
GIP
Time Frame: Change from Baseline to 45-minutes after consumption of the beverage.
Change from Baseline to 45-minutes after consumption of the beverage.
GIP
Time Frame: Change from Baseline to 60-minutes after consumption of the beverage.
Change from Baseline to 60-minutes after consumption of the beverage.
GIP
Time Frame: Change from Baseline to 75-minutes after consumption of the beverage.
Change from Baseline to 75-minutes after consumption of the beverage.
GIP
Time Frame: Change from Baseline to 90-minutes after consumption of the beverage.
Change from Baseline to 90-minutes after consumption of the beverage.
GIP
Time Frame: Change from Baseline to 105-minutes after consumption of the beverage.
Change from Baseline to 105-minutes after consumption of the beverage.
GIP
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Change from Baseline to 120-minutes after consumption of the beverage.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Leptin
Time Frame: Change from Baseline to 60-minutes after consumption of the beverage.
Change from Baseline to 60-minutes after consumption of the beverage.
Leptin
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Change from Baseline to 120-minutes after consumption of the beverage.
Glucagon
Time Frame: Change from Baseline to 60-minutes after consumption of the beverage.
Change from Baseline to 60-minutes after consumption of the beverage.
Glucagon
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Change from Baseline to 120-minutes after consumption of the beverage.
Ghrelin
Time Frame: Change from Baseline to 60-minutes after consumption of the beverage.
Change from Baseline to 60-minutes after consumption of the beverage.
Ghrelin
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Change from Baseline to 120-minutes after consumption of the beverage.
Polypeptide Y
Time Frame: Change from Baseline to 60-minutes after consumption of the beverage.
Change from Baseline to 60-minutes after consumption of the beverage.
Polypeptide Y
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Change from Baseline to 120-minutes after consumption of the beverage.
Pancreatic polypeptide
Time Frame: Change from Baseline to 60-minutes after consumption of the beverage.
Change from Baseline to 60-minutes after consumption of the beverage.
Pancreatic polypeptide
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Change from Baseline to 120-minutes after consumption of the beverage.
HDL cholesterol
Time Frame: Change from Baseline to 60-minutes after consumption of the beverage.
Change from Baseline to 60-minutes after consumption of the beverage.
HDL cholesterol
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Change from Baseline to 120-minutes after consumption of the beverage.
LDL cholesterol
Time Frame: Change from Baseline to 60-minutes after consumption of the beverage.
Change from Baseline to 60-minutes after consumption of the beverage.
LDL cholesterol
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Change from Baseline to 120-minutes after consumption of the beverage.
Triglycerides
Time Frame: Change from Baseline to 60-minutes after consumption of the beverage.
Change from Baseline to 60-minutes after consumption of the beverage.
Triglycerides
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Change from Baseline to 120-minutes after consumption of the beverage.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Zaragoza

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto de Salud Carlos III

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI19/477

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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