Effect of the Consumption of Alcohol-free Beers With Different Carbohydrates Composition on Postprandial Metabolic Response
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Zaragoza
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Glucose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Glucose
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
GLP-1
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
GIP
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Insulin
Time Frame: Change from Baseline to 120-minutes after consumption of the beverage.
Secondary Outcomes
- 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.)
Investigators
Rocio Mateo-Gallego
PhD
Universidad de Zaragoza