Clinical trial NCT04790877: Effect of the Consumption of Alcohol-free Beers With Different Carbohydrates Composition on Postprandial Metabolic Response
Official title: Effect of the Consumption of Alcohol-free Beers With Different Carbohydrates Composition on Postprandial Metabolic Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Diet
Postprandial Hyperglycemia
Keywords: Carbohydrates
Alcohol-free beer
Maltodextrin
Isomaltulose
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2021-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The overall study involved two sub-studies. The first one includes 4 arms and the second one includes 5 arms.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glucose
timeFrame: Change from Baseline to 15-minutes after consumption of the beverage.
measure: Glucose
timeFrame: Change from Baseline to 30-minutes after consumption of the beverage.
measure: Glucose
timeFrame: Change from Baseline to 45-minutes after consumption of the beverage.
measure: Glucose
timeFrame: Change from Baseline to 60-minutes after consumption of the beverage.
measure: Glucose
timeFrame: Change from Baseline to 75-minutes after consumption of the beverage.
measure: Glucose
timeFrame: Change from Baseline to 90-minutes after consumption of the beverage.
measure: Glucose
timeFrame: Change from Baseline to 105-minutes after consumption of the beverage.
measure: Glucose
timeFrame: Change from Baseline to 120-minutes after consumption of the beverage.
measure: Insulin
timeFrame: Change from Baseline to 15-minutes after consumption of the beverage.
measure: Insulin
timeFrame: Change from Baseline to 30-minutes after consumption of the beverage.
measure: Insulin
timeFrame: Change from Baseline to 45-minutes after consumption of the beverage.
measure: Insulin
timeFrame: Change from Baseline to 60-minutes after consumption of the beverage.
measure: Insulin
timeFrame: Change from Baseline to 75-minutes after consumption of the beverage.
measure: Insulin
timeFrame: Change from Baseline to 90-minutes after consumption of the beverage.
measure: Insulin
timeFrame: Change from Baseline to 105-minutes after consumption of the beverage.
measure: Insulin
timeFrame: Change from Baseline to 120-minutes after consumption of the beverage.
measure: GLP-1
timeFrame: Change from Baseline to 15-minutes after consumption of the beverage.
measure: GLP-1
timeFrame: Change from Baseline to 30-minutes after consumption of the beverage.
measure: GLP-1
timeFrame: Change from Baseline to 45-minutes after consumption of the beverage.
measure: GLP-1
timeFrame: Change from Baseline to 60-minutes after consumption of the beverage.
measure: GLP-1
timeFrame: Change from Baseline to 75-minutes after consumption of the beverage.
measure: GLP-1
timeFrame: Change from Baseline to 90-minutes after consumption of the beverage.
measure: GLP-1
timeFrame: Change from Baseline to 105-minutes after consumption of the beverage.
measure: GLP-1
timeFrame: Change from Baseline to 120-minutes after consumption of the beverage.
measure: GIP
timeFrame: Change from Baseline to 15-minutes after consumption of the beverage.
measure: GIP
timeFrame: Change from Baseline to 30-minutes after consumption of the beverage.
measure: GIP
timeFrame: Change from Baseline to 45-minutes after consumption of the beverage.
measure: GIP
timeFrame: Change from Baseline to 60-minutes after consumption of the beverage.
measure: GIP
timeFrame: Change from Baseline to 75-minutes after consumption of the beverage.
measure: GIP
timeFrame: Change from Baseline to 90-minutes after consumption of the beverage.
measure: GIP
timeFrame: Change from Baseline to 105-minutes after consumption of the beverage.
measure: GIP
timeFrame: Change from Baseline to 120-minutes after consumption of the beverage.
Secondary outcomes:
measure: Leptin
timeFrame: Change from Baseline to 60-minutes after consumption of the beverage.
measure: Leptin
timeFrame: Change from Baseline to 120-minutes after consumption of the beverage.
measure: Glucagon
timeFrame: Change from Baseline to 60-minutes after consumption of the beverage.
measure: Glucagon
timeFrame: Change from Baseline to 120-minutes after consumption of the beverage.
measure: Ghrelin
timeFrame: Change from Baseline to 60-minutes after consumption of the beverage.
measure: Ghrelin
timeFrame: Change from Baseline to 120-minutes after consumption of the beverage.
measure: Polypeptide Y
timeFrame: Change from Baseline to 60-minutes after consumption of the beverage.
measure: Polypeptide Y
timeFrame: Change from Baseline to 120-minutes after consumption of the beverage.
measure: Pancreatic polypeptide
timeFrame: Change from Baseline to 60-minutes after consumption of the beverage.
measure: Pancreatic polypeptide
timeFrame: Change from Baseline to 120-minutes after consumption of the beverage.
measure: HDL cholesterol
timeFrame: Change from Baseline to 60-minutes after consumption of the beverage.
measure: HDL cholesterol
timeFrame: Change from Baseline to 120-minutes after consumption of the beverage.
measure: LDL cholesterol
timeFrame: Change from Baseline to 60-minutes after consumption of the beverage.
measure: LDL cholesterol
timeFrame: Change from Baseline to 120-minutes after consumption of the beverage.
measure: Triglycerides
timeFrame: Change from Baseline to 60-minutes after consumption of the beverage.
measure: Triglycerides
timeFrame: Change from Baseline to 120-minutes after consumption of the beverage.
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza
Study officials:
References: