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

Healthy Diet Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790877
• Other study ID #: PI19/477
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: September 2021
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Diet
• Hyperglycemia
• Postprandial Hyperglycemia

Intervention

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).
• 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.

Locations

Country	Name	City	State
Spain	Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Zaragoza	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose		Change from Baseline to 15-minutes after consumption of the beverage.
Primary	Glucose		Change from Baseline to 30-minutes after consumption of the beverage.
Primary	Glucose		Change from Baseline to 45-minutes after consumption of the beverage.
Primary	Glucose		Change from Baseline to 60-minutes after consumption of the beverage.
Primary	Glucose		Change from Baseline to 75-minutes after consumption of the beverage.
Primary	Glucose		Change from Baseline to 90-minutes after consumption of the beverage.
Primary	Glucose		Change from Baseline to 105-minutes after consumption of the beverage.
Primary	Glucose		Change from Baseline to 120-minutes after consumption of the beverage.
Primary	Insulin		Change from Baseline to 15-minutes after consumption of the beverage.
Primary	Insulin		Change from Baseline to 30-minutes after consumption of the beverage.
Primary	Insulin		Change from Baseline to 45-minutes after consumption of the beverage.
Primary	Insulin		Change from Baseline to 60-minutes after consumption of the beverage.
Primary	Insulin		Change from Baseline to 75-minutes after consumption of the beverage.
Primary	Insulin		Change from Baseline to 90-minutes after consumption of the beverage.
Primary	Insulin		Change from Baseline to 105-minutes after consumption of the beverage.
Primary	Insulin		Change from Baseline to 120-minutes after consumption of the beverage.
Primary	GLP-1		Change from Baseline to 15-minutes after consumption of the beverage.
Primary	GLP-1		Change from Baseline to 30-minutes after consumption of the beverage.
Primary	GLP-1		Change from Baseline to 45-minutes after consumption of the beverage.
Primary	GLP-1		Change from Baseline to 60-minutes after consumption of the beverage.
Primary	GLP-1		Change from Baseline to 75-minutes after consumption of the beverage.
Primary	GLP-1		Change from Baseline to 90-minutes after consumption of the beverage.
Primary	GLP-1		Change from Baseline to 105-minutes after consumption of the beverage.
Primary	GLP-1		Change from Baseline to 120-minutes after consumption of the beverage.
Primary	GIP		Change from Baseline to 15-minutes after consumption of the beverage.
Primary	GIP		Change from Baseline to 30-minutes after consumption of the beverage.
Primary	GIP		Change from Baseline to 45-minutes after consumption of the beverage.
Primary	GIP		Change from Baseline to 60-minutes after consumption of the beverage.
Primary	GIP		Change from Baseline to 75-minutes after consumption of the beverage.
Primary	GIP		Change from Baseline to 90-minutes after consumption of the beverage.
Primary	GIP		Change from Baseline to 105-minutes after consumption of the beverage.
Primary	GIP		Change from Baseline to 120-minutes after consumption of the beverage.
Secondary	Leptin		Change from Baseline to 60-minutes after consumption of the beverage.
Secondary	Leptin		Change from Baseline to 120-minutes after consumption of the beverage.
Secondary	Glucagon		Change from Baseline to 60-minutes after consumption of the beverage.
Secondary	Glucagon		Change from Baseline to 120-minutes after consumption of the beverage.
Secondary	Ghrelin		Change from Baseline to 60-minutes after consumption of the beverage.
Secondary	Ghrelin		Change from Baseline to 120-minutes after consumption of the beverage.
Secondary	Polypeptide Y		Change from Baseline to 60-minutes after consumption of the beverage.
Secondary	Polypeptide Y		Change from Baseline to 120-minutes after consumption of the beverage.
Secondary	Pancreatic polypeptide		Change from Baseline to 60-minutes after consumption of the beverage.
Secondary	Pancreatic polypeptide		Change from Baseline to 120-minutes after consumption of the beverage.
Secondary	HDL cholesterol		Change from Baseline to 60-minutes after consumption of the beverage.
Secondary	HDL cholesterol		Change from Baseline to 120-minutes after consumption of the beverage.
Secondary	LDL cholesterol		Change from Baseline to 60-minutes after consumption of the beverage.
Secondary	LDL cholesterol		Change from Baseline to 120-minutes after consumption of the beverage.
Secondary	Triglycerides		Change from Baseline to 60-minutes after consumption of the beverage.
Secondary	Triglycerides		Change from Baseline to 120-minutes after consumption of the beverage.