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

NCT ID: NCT04790877

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Diet Postprandial Hyperglycemia

Keywords

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Carbohydrates Alcohol-free beer Maltodextrin Isomaltulose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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First sub-study: Glucose beverage

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

Group Type ACTIVE_COMPARATOR

Sub-study 1

Intervention Type OTHER

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).

First sub-study: Regular alcohol-free beer

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

Group Type EXPERIMENTAL

Sub-study 1

Intervention Type OTHER

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).

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.

Group Type EXPERIMENTAL

Sub-study 1

Intervention Type OTHER

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).

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.

Group Type EXPERIMENTAL

Sub-study 1

Intervention Type OTHER

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).

Second sub-study: White bread + Water

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

Group Type ACTIVE_COMPARATOR

Sub-study 2

Intervention Type OTHER

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.

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).

Group Type EXPERIMENTAL

Sub-study 2

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Sub-study 2

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Sub-study 2

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Sub-study 2

Intervention Type OTHER

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.

Interventions

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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).

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Universidad de Zaragoza

OTHER

Sponsor Role lead

Responsible Party

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Rocio Mateo-Gallego

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PI19/477

Identifier Type: -

Identifier Source: org_study_id