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

University of Zaragoza

Status: Completed

Conditions: Postprandial Hyperglycemia; Healthy Diet

Treatments: Other: Sub-study 1; Other: Sub-study 2

Study type: Interventional

Funder types: Other

Identifiers

NCT04790877

PI19/477

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 9 patient groups

First sub-study: Glucose beverage

Active Comparator group

Description:

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

Treatment:

Other: Sub-study 1

First sub-study: Regular alcohol-free beer

Experimental group

Description:

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

Treatment:

Other: Sub-study 1

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

Experimental group

Description:

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.

Treatment:

Other: Sub-study 1

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

Experimental group

Description:

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.

Treatment:

Other: Sub-study 1

Second sub-study: White bread + Water

Active Comparator group

Description:

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

Treatment:

Other: Sub-study 2

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

Experimental group

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).

Treatment:

Other: Sub-study 2

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

Experimental group

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 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.

Treatment:

Other: Sub-study 2

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

Experimental group

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.

Treatment:

Other: Sub-study 2

Second sub-study: Extra-White bread + Water

Active Comparator group

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.

Treatment:

Other: Sub-study 2