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

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: Completed
• Conditions: Healthy Diet; Postprandial Hyperglycemia
• Intervention / Treatment: Other: Sub-study 1; Other: Sub-study 2

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 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

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Glucose	Change from Baseline to 15-minutes after consumption of the beverage.
Glucose	Change from Baseline to 30-minutes after consumption of the beverage.
Glucose	Change from Baseline to 45-minutes after consumption of the beverage.
Glucose	Change from Baseline to 60-minutes after consumption of the beverage.
Glucose	Change from Baseline to 75-minutes after consumption of the beverage.
Glucose	Change from Baseline to 90-minutes after consumption of the beverage.
Glucose	Change from Baseline to 105-minutes after consumption of the beverage.
Glucose	Change from Baseline to 120-minutes after consumption of the beverage.
Insulin	Change from Baseline to 15-minutes after consumption of the beverage.
Insulin	Change from Baseline to 30-minutes after consumption of the beverage.
Insulin	Change from Baseline to 45-minutes after consumption of the beverage.
Insulin	Change from Baseline to 60-minutes after consumption of the beverage.
Insulin	Change from Baseline to 75-minutes after consumption of the beverage.
Insulin	Change from Baseline to 90-minutes after consumption of the beverage.
Insulin	Change from Baseline to 105-minutes after consumption of the beverage.
Insulin	Change from Baseline to 120-minutes after consumption of the beverage.
GLP-1	Change from Baseline to 15-minutes after consumption of the beverage.
GLP-1	Change from Baseline to 30-minutes after consumption of the beverage.
GLP-1	Change from Baseline to 45-minutes after consumption of the beverage.
GLP-1	Change from Baseline to 60-minutes after consumption of the beverage.
GLP-1	Change from Baseline to 75-minutes after consumption of the beverage.
GLP-1	Change from Baseline to 90-minutes after consumption of the beverage.
GLP-1	Change from Baseline to 105-minutes after consumption of the beverage.
GLP-1	Change from Baseline to 120-minutes after consumption of the beverage.
GIP	Change from Baseline to 15-minutes after consumption of the beverage.
GIP	Change from Baseline to 30-minutes after consumption of the beverage.
GIP	Change from Baseline to 45-minutes after consumption of the beverage.
GIP	Change from Baseline to 60-minutes after consumption of the beverage.
GIP	Change from Baseline to 75-minutes after consumption of the beverage.
GIP	Change from Baseline to 90-minutes after consumption of the beverage.
GIP	Change from Baseline to 105-minutes after consumption of the beverage.
GIP	Change from Baseline to 120-minutes after consumption of the beverage.

Secondary Outcome Measures

Outcome Measure	Time Frame
Leptin	Change from Baseline to 60-minutes after consumption of the beverage.
Leptin	Change from Baseline to 120-minutes after consumption of the beverage.
Glucagon	Change from Baseline to 60-minutes after consumption of the beverage.
Glucagon	Change from Baseline to 120-minutes after consumption of the beverage.
Ghrelin	Change from Baseline to 60-minutes after consumption of the beverage.
Ghrelin	Change from Baseline to 120-minutes after consumption of the beverage.
Polypeptide Y	Change from Baseline to 60-minutes after consumption of the beverage.
Polypeptide Y	Change from Baseline to 120-minutes after consumption of the beverage.
Pancreatic polypeptide	Change from Baseline to 60-minutes after consumption of the beverage.
Pancreatic polypeptide	Change from Baseline to 120-minutes after consumption of the beverage.
HDL cholesterol	Change from Baseline to 60-minutes after consumption of the beverage.
HDL cholesterol	Change from Baseline to 120-minutes after consumption of the beverage.
LDL cholesterol	Change from Baseline to 60-minutes after consumption of the beverage.
LDL cholesterol	Change from Baseline to 120-minutes after consumption of the beverage.
Triglycerides	Change from Baseline to 60-minutes after consumption of the beverage.
Triglycerides	Change from Baseline to 120-minutes after consumption of the beverage.

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza
• Collaborators: Instituto de Salud Carlos III

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Carbohydrates; Isomaltulose; Maltodextrin; Alcohol-free beer
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID 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