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

Primary Purpose

Healthy Diet, Postprandial Hyperglycemia

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Sub-study 1

Sub-study 2

About this trial

This is an interventional prevention trial for Healthy Diet focused on measuring Carbohydrates, Alcohol-free beer, Maltodextrin, Isomaltulose

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

First sub-study: Glucose beverage

First sub-study: Regular alcohol-free beer

First sub-study: Alcohol-free beer with modified composition (isomaltulose + maltodextrin)

First sub-study: Alcohol-free beer with modified composition (++ maltodextrin)

Second sub-study: White bread + Water

Second sub-study: White bread + Regular alcohol-free beer

Second sub-study: White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin)

Second sub-study: White bread + Alcohol-free beer enriched with ++ maltodextrin

Second sub-study: Extra-White bread + Water

Arm Description

This intervention entails the intake of a beverage including 25 g of glucose.

This intervention entails the intake of regular alcohol-free beer including 25 of carbohydrates.

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.

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.

This intervention entails the intake of white bread (providing 50 g of carbohydrates) and water.

This intervention entails the intake of white bread (providing 50 g of carbohydrates) and regular alcohol-free beer (providing 14.3 g of carbohydrates).

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.

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.

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.

Outcomes

Primary Outcome Measures

Glucose

Insulin

GLP-1

GIP

Secondary Outcome Measures

Leptin

Glucagon

Ghrelin

Polypeptide Y

Pancreatic polypeptide

HDL cholesterol

LDL cholesterol

Triglycerides

Full Information

NCT ID

NCT04790877

First Posted

March 2, 2021

Last Updated

September 29, 2021

Sponsor

Universidad de Zaragoza

Collaborators

Instituto de Salud Carlos III

1. Study Identification

Unique Protocol Identification Number

NCT04790877

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

February 1, 2020 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de Zaragoza

Collaborators

Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Diet, Postprandial Hyperglycemia

Keywords

Carbohydrates, Alcohol-free beer, Maltodextrin, Isomaltulose

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

The overall study involved two sub-studies. The first one includes 4 arms and the second one includes 5 arms.

Masking

ParticipantInvestigator

Masking Description

The investigator who prepares the beverages and the bread is not blinded but the investigator who manage the samples and is plan to analyze the results is blinded.

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

First sub-study: Glucose beverage

Arm Type

Active Comparator

Arm Description

This intervention entails the intake of a beverage including 25 g of glucose.

Arm Title

First sub-study: Regular alcohol-free beer

Arm Type

Experimental

Arm Description

This intervention entails the intake of regular alcohol-free beer including 25 of carbohydrates.

Arm Title

First sub-study: Alcohol-free beer with modified composition (isomaltulose + maltodextrin)

Arm Type

Experimental

Arm Description

Arm Title

First sub-study: Alcohol-free beer with modified composition (++ maltodextrin)

Arm Type

Experimental

Arm Description

Arm Title

Second sub-study: White bread + Water

Arm Type

Active Comparator

Arm Description

This intervention entails the intake of white bread (providing 50 g of carbohydrates) and water.

Arm Title

Second sub-study: White bread + Regular alcohol-free beer

Arm Type

Experimental

Arm Description

This intervention entails the intake of white bread (providing 50 g of carbohydrates) and regular alcohol-free beer (providing 14.3 g of carbohydrates).

Arm Title

Second sub-study: White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin)

Arm Type

Experimental

Arm Description

Arm Title

Second sub-study: White bread + Alcohol-free beer enriched with ++ maltodextrin

Arm Type

Experimental

Arm Description

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.

Arm Title

Second sub-study: Extra-White bread + Water

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Sub-study 1

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Sub-study 2

Intervention Description

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.

Primary Outcome Measure Information:

Title

Glucose

Time Frame

Change from Baseline to 15-minutes after consumption of the beverage.

Title

Glucose

Time Frame

Change from Baseline to 30-minutes after consumption of the beverage.

Title

Glucose

Time Frame

Change from Baseline to 45-minutes after consumption of the beverage.

Title

Glucose

Time Frame

Change from Baseline to 60-minutes after consumption of the beverage.

Title

Glucose

Time Frame

Change from Baseline to 75-minutes after consumption of the beverage.

Title

Glucose

Time Frame

Change from Baseline to 90-minutes after consumption of the beverage.

Title

Glucose

Time Frame

Change from Baseline to 105-minutes after consumption of the beverage.

Title

Glucose

Time Frame

Change from Baseline to 120-minutes after consumption of the beverage.

Title

Insulin

Time Frame

Change from Baseline to 15-minutes after consumption of the beverage.

Title

Insulin

Time Frame

Change from Baseline to 30-minutes after consumption of the beverage.

Title

Insulin

Time Frame

Change from Baseline to 45-minutes after consumption of the beverage.

Title

Insulin

Time Frame

Change from Baseline to 60-minutes after consumption of the beverage.

Title

Insulin

Time Frame

Change from Baseline to 75-minutes after consumption of the beverage.

Title

Insulin

Time Frame

Change from Baseline to 90-minutes after consumption of the beverage.

Title

Insulin

Time Frame

Change from Baseline to 105-minutes after consumption of the beverage.

Title

Insulin

Time Frame

Change from Baseline to 120-minutes after consumption of the beverage.

Title

GLP-1

Time Frame

Change from Baseline to 15-minutes after consumption of the beverage.

Title

GLP-1

Time Frame

Change from Baseline to 30-minutes after consumption of the beverage.

Title

GLP-1

Time Frame

Change from Baseline to 45-minutes after consumption of the beverage.

Title

GLP-1

Time Frame

Change from Baseline to 60-minutes after consumption of the beverage.

Title

GLP-1

Time Frame

Change from Baseline to 75-minutes after consumption of the beverage.

Title

GLP-1

Time Frame

Change from Baseline to 90-minutes after consumption of the beverage.

Title

GLP-1

Time Frame

Change from Baseline to 105-minutes after consumption of the beverage.

Title

GLP-1

Time Frame

Change from Baseline to 120-minutes after consumption of the beverage.

Title

GIP

Time Frame

Change from Baseline to 15-minutes after consumption of the beverage.

Title

GIP

Time Frame

Change from Baseline to 30-minutes after consumption of the beverage.

Title

GIP

Time Frame

Change from Baseline to 45-minutes after consumption of the beverage.

Title

GIP

Time Frame

Change from Baseline to 60-minutes after consumption of the beverage.

Title

GIP

Time Frame

Change from Baseline to 75-minutes after consumption of the beverage.

Title

GIP

Time Frame

Change from Baseline to 90-minutes after consumption of the beverage.

Title

GIP

Time Frame

Change from Baseline to 105-minutes after consumption of the beverage.

Title

GIP

Time Frame

Change from Baseline to 120-minutes after consumption of the beverage.

Secondary Outcome Measure Information:

Title

Leptin

Time Frame

Change from Baseline to 60-minutes after consumption of the beverage.

Title

Leptin

Time Frame

Change from Baseline to 120-minutes after consumption of the beverage.

Title

Glucagon

Time Frame

Change from Baseline to 60-minutes after consumption of the beverage.

Title

Glucagon

Time Frame

Change from Baseline to 120-minutes after consumption of the beverage.

Title

Ghrelin

Time Frame

Change from Baseline to 60-minutes after consumption of the beverage.

Title

Ghrelin

Time Frame

Change from Baseline to 120-minutes after consumption of the beverage.

Title

Polypeptide Y

Time Frame

Change from Baseline to 60-minutes after consumption of the beverage.

Title

Polypeptide Y

Time Frame

Change from Baseline to 120-minutes after consumption of the beverage.

Title

Pancreatic polypeptide

Time Frame

Change from Baseline to 60-minutes after consumption of the beverage.

Title

Pancreatic polypeptide

Time Frame

Change from Baseline to 120-minutes after consumption of the beverage.

Title

HDL cholesterol

Time Frame

Change from Baseline to 60-minutes after consumption of the beverage.

Title

HDL cholesterol

Time Frame

Change from Baseline to 120-minutes after consumption of the beverage.

Title

LDL cholesterol

Time Frame

Change from Baseline to 60-minutes after consumption of the beverage.

Title

LDL cholesterol

Time Frame

Change from Baseline to 120-minutes after consumption of the beverage.

Title

Triglycerides

Time Frame

Change from Baseline to 60-minutes after consumption of the beverage.

Title

Triglycerides

Time Frame

Change from Baseline to 120-minutes after consumption of the beverage.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

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

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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