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

Not Applicable

Completed

• Conditions: Healthy Diet; Postprandial Hyperglycemia
• Interventions: Other: Sub-study 1; Other: Sub-study 2

• Registration Number: NCT04790877
• Lead Sponsor: Universidad de Zaragoza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2020-12-31
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-10
• Study Completion: 2021-03-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First sub-study: Alcohol-free beer with modified composition (isomaltulose + maltodextrin)	Sub-study 1	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.
Second sub-study: White bread + Water	Sub-study 2	This intervention entails the intake of white bread (providing 50 g of carbohydrates) and water.
First sub-study: Glucose beverage	Sub-study 1	This intervention entails the intake of a beverage including 25 g of glucose.
Second sub-study: White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin)	Sub-study 2	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.
First sub-study: Regular alcohol-free beer	Sub-study 1	This intervention entails the intake of regular alcohol-free beer including 25 of carbohydrates.
First sub-study: Alcohol-free beer with modified composition (++ maltodextrin)	Sub-study 1	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.
Second sub-study: White bread + Alcohol-free beer enriched with ++ maltodextrin	Sub-study 2	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.
Second sub-study: White bread + Regular alcohol-free beer	Sub-study 2	This intervention entails the intake of white bread (providing 50 g of carbohydrates) and regular alcohol-free beer (providing 14.3 g of carbohydrates).
Second sub-study: Extra-White bread + Water	Sub-study 2	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.

Primary Outcome Measures

Name	Time	Method
Glucose	Change from Baseline to 120-minutes after consumption of the beverage.
GLP-1	Change from Baseline to 120-minutes after consumption of the beverage.
GIP	Change from Baseline to 120-minutes after consumption of the beverage.
Insulin	Change from Baseline to 120-minutes after consumption of the beverage.

Secondary Outcome Measures

Name	Time	Method
Pancreatic polypeptide	Change from Baseline to 120-minutes after consumption of the beverage.
LDL cholesterol	Change from Baseline to 120-minutes after consumption of the beverage.
Leptin	Change from Baseline to 120-minutes after consumption of the beverage.
Polypeptide Y	Change from Baseline to 120-minutes after consumption of the beverage.
Triglycerides	Change from Baseline to 120-minutes after consumption of the beverage.
Glucagon	Change from Baseline to 120-minutes after consumption of the beverage.
Ghrelin	Change from Baseline to 120-minutes after consumption of the beverage.
HDL cholesterol	Change from Baseline to 120-minutes after consumption of the beverage.

Trial Locations

Locations (1)

Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza; 🇪🇸 Zaragoza, Spain