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

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.

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

Conditions
-----------------
Healthy Diet, Postprandial Hyperglycemia

Intervention / Treatment
-----------------
* Other: Sub-study 1
* Other: Sub-study 2


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The overall study involved two sub-studies. The first one includes 4 arms and the second one includes 5 arms.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First sub-study: Glucose beverage<br>This intervention entails the intake of a beverage including 25 g of glucose. | Other: Sub-study 1<br>* 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).<br>|
| Experimental: First sub-study: Regular alcohol-free beer<br>This intervention entails the intake of regular alcohol-free beer including 25 of carbohydrates. | Other: Sub-study 1<br>* 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).<br>|
| Experimental: First sub-study: Alcohol-free beer with modified composition (isomaltulose + maltodextrin)<br>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<br>* 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).<br>|
| Experimental: First sub-study: Alcohol-free beer with modified composition (++ maltodextrin)<br>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<br>* 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).<br>|
| Active Comparator: Second sub-study: White bread + Water<br>This intervention entails the intake of white bread (providing 50 g of carbohydrates) and water. | Other: Sub-study 2<br>* 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.<br>|
| Experimental: Second sub-study: White bread + Regular alcohol-free beer<br>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<br>* 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.<br>|
| Experimental: Second sub-study: White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin)<br>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<br>* 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.<br>|
| Experimental: Second sub-study: White bread + Alcohol-free beer enriched with ++ maltodextrin<br>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<br>* 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.<br>|
| Active Comparator: Second sub-study: Extra-White bread + Water<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carbohydrates, Alcohol-free beer, Maltodextrin, Isomaltulose