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

NCT04790877 | Completed

• 1 other identifier: PI19/477
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Diet; Postprandial Hyperglycemia

Keywords

Carbohydrates; Alcohol-free beer; Maltodextrin; Isomaltulose

Outcome Measures

Primary Outcomes (32)

• 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 Outcomes (16)

• 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.

Study Arms (9)

First sub-study: Glucose beverage

ACTIVE COMPARATOR

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

Other: Sub-study 1

First sub-study: Regular alcohol-free beer

EXPERIMENTAL

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

Other: Sub-study 1

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Second sub-study: White bread + Water

ACTIVE COMPARATOR

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

Other: Sub-study 2

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Second sub-study: Extra-White bread + Water

ACTIVE COMPARATOR

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

Interventions

Sub-study 1 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); First sub-study: Alcohol-free beer with modified composition (isomaltulose + maltodextrin); First sub-study: Glucose beverage; First sub-study: Regular alcohol-free beer

Sub-study 2 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; Second sub-study: White bread + Alcohol-free beer enriched with ++ maltodextrin; Second sub-study: White bread + Regular alcohol-free beer; Second sub-study: White bread + Water; Second sub-study: White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI between 18.5 and 27.5 kg/m2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

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

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

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

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 10, 2021
• Study Start: February 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: March 30, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)