Effect of the Consumption of Alcohol-free Beers With Different Carbohydrates Composition on Postprandial Metabolic Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- GLP-1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.5 and 27.5 kg/m2.
排除标准
- •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.
研究组 & 干预措施
First sub-study: Glucose beverage
This intervention entails the intake of a beverage including 25 g of glucose.
干预措施: Sub-study 1 (Other)
First sub-study: Regular alcohol-free beer
This intervention entails the intake of regular alcohol-free beer including 25 of carbohydrates.
干预措施: Sub-study 1 (Other)
First sub-study: Alcohol-free beer with modified composition (isomaltulose + maltodextrin)
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.
干预措施: Sub-study 1 (Other)
First sub-study: Alcohol-free beer with modified composition (++ maltodextrin)
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.
干预措施: Sub-study 1 (Other)
Second sub-study: White bread + Water
This intervention entails the intake of white bread (providing 50 g of carbohydrates) and water.
干预措施: Sub-study 2 (Other)
Second sub-study: White bread + Regular alcohol-free beer
This intervention entails the intake of white bread (providing 50 g of carbohydrates) and regular alcohol-free beer (providing 14.3 g of carbohydrates).
干预措施: Sub-study 2 (Other)
Second sub-study: White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin)
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.
干预措施: Sub-study 2 (Other)
Second sub-study: White bread + Alcohol-free beer enriched with ++ maltodextrin
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.
干预措施: Sub-study 2 (Other)
Second sub-study: Extra-White bread + Water
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.
干预措施: Sub-study 2 (Other)
结局指标
主要结局
GLP-1
时间窗: Change from Baseline to 120-minutes after consumption of the beverage.
Glucose
时间窗: Change from Baseline to 120-minutes after consumption of the beverage.
GIP
时间窗: Change from Baseline to 120-minutes after consumption of the beverage.
Insulin
时间窗: Change from Baseline to 120-minutes after consumption of the beverage.
GIP
时间窗: Change from Baseline to 45-minutes after consumption of the beverage.
GIP
时间窗: Change from Baseline to 60-minutes after consumption of the beverage.
GIP
时间窗: Change from Baseline to 75-minutes after consumption of the beverage.
GIP
时间窗: Change from Baseline to 90-minutes after consumption of the beverage.
GIP
时间窗: Change from Baseline to 105-minutes after consumption of the beverage.
GLP-1
时间窗: Change from Baseline to 30-minutes after consumption of the beverage.
GLP-1
时间窗: Change from Baseline to 45-minutes after consumption of the beverage.
GLP-1
时间窗: Change from Baseline to 60-minutes after consumption of the beverage.
Glucose
时间窗: Change from Baseline to 75-minutes after consumption of the beverage.
Glucose
时间窗: Change from Baseline to 90-minutes after consumption of the beverage.
Glucose
时间窗: Change from Baseline to 15-minutes after consumption of the beverage.
Glucose
时间窗: Change from Baseline to 30-minutes after consumption of the beverage.
Glucose
时间窗: Change from Baseline to 45-minutes after consumption of the beverage.
Glucose
时间窗: Change from Baseline to 60-minutes after consumption of the beverage.
Glucose
时间窗: Change from Baseline to 105-minutes after consumption of the beverage.
Insulin
时间窗: Change from Baseline to 15-minutes after consumption of the beverage.
Insulin
时间窗: Change from Baseline to 30-minutes after consumption of the beverage.
Insulin
时间窗: Change from Baseline to 45-minutes after consumption of the beverage.
Insulin
时间窗: Change from Baseline to 60-minutes after consumption of the beverage.
Insulin
时间窗: Change from Baseline to 75-minutes after consumption of the beverage.
Insulin
时间窗: Change from Baseline to 90-minutes after consumption of the beverage.
Insulin
时间窗: Change from Baseline to 105-minutes after consumption of the beverage.
GLP-1
时间窗: Change from Baseline to 15-minutes after consumption of the beverage.
GLP-1
时间窗: Change from Baseline to 75-minutes after consumption of the beverage.
GLP-1
时间窗: Change from Baseline to 90-minutes after consumption of the beverage.
GLP-1
时间窗: Change from Baseline to 105-minutes after consumption of the beverage.
GIP
时间窗: Change from Baseline to 15-minutes after consumption of the beverage.
GIP
时间窗: Change from Baseline to 30-minutes after consumption of the beverage.
次要结局
- Leptin(Change from Baseline to 120-minutes after consumption of the beverage.)
- 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.)
- 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.)
- Leptin(Change from Baseline to 60-minutes after consumption of the beverage.)
- Glucagon(Change from Baseline to 60-minutes after consumption of the beverage.)
- Ghrelin(Change from Baseline to 60-minutes after consumption of the beverage.)
- Polypeptide Y(Change from Baseline to 60-minutes after consumption of the beverage.)
- Pancreatic polypeptide(Change from Baseline to 60-minutes after consumption of the beverage.)
- HDL cholesterol(Change from Baseline to 60-minutes after consumption of the beverage.)
- LDL cholesterol(Change from Baseline to 60-minutes after consumption of the beverage.)
- Triglycerides(Change from Baseline to 60-minutes after consumption of the beverage.)
研究者
Rocio Mateo-Gallego
PhD
Universidad de Zaragoza