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临床试验/NCT03104712
NCT03104712已完成不适用

The Importance of Glycemic Index on Postprandial Glycemia and Insulinemia in the Context of the Addition of Fat to Carbohydrate Foods: A Randomized Controlled Trial on Spaghetti Versus Rice as Mixed Meals

University of Parma1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2017年4月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Glycemic Index

研究概览

简要总结

Pasta and rice are two of the most commonly consumed grains worldwide, where the former has a low GI (e.g. spaghetti) and the latter, usually (as it depends on the type) has a higher GI (e.g. white rice). The most typical ways in which pasta and rice are consumed are with the addition of oil or tomato sauce, and are recommended to be consumed in this way in the Mediterranean diet. The Mediterranean diet has been demonstrated to reduce the risk of cardiovascular disease, improve glycemic control and is encouraged in many clinical guidelines globally for both cardiovascular risk reduction. Some studies have explored the differences in glycemic response of different carbohydrate foods consumed with the addition of fat demonstrating that the glycemic response is indeed reduced.However, the GI may remain of importance even when other means to reduce glycemic response are introduced.

The investigators therefore designed a randomized controlled crossover study to explore whether the addition of fat in the form of commonly consumed sauces which are recommended as part of a Mediterranean diet, affects the difference in glycemic response between a commonly consumed low GI and a higher GI carbohydrate food.

详细描述

Background:

Pasta and rice are two of the most commonly consumed grains worldwide, where the former has a low GI (e.g. spaghetti) and the latter, usually (as it depends on the type) has a higher GI (e.g. white rice). Low GI foods have been demonstrated to improve glycemic control, insulin sensitivity and diabetes management, and have been associated with reduced risk of chronic disease, including coronary heart disease. Therefore, GI is of importance as a potential dietary strategy to reduce postprandial glycemia and improve glycemic control, particularly with the increasing rates of diabetes.

Several studies have demonstrated how the addition of fat to a meal can reduce the glycemic response, some of which have suggested in a dose response manner. The mechanism by which increasing fat reduces the glycemic response may be through the effects on gastric emptying. Fat may modulate the gut hormones cholecystokinin (CCK) and peptide YY, which delay gastric emptying, which is known to be a major determinant of postprandial glycemia where small changes can have a substantial effect. Low GI foods result in lower glycemic excursions compared to higher GI foods, which, in addition to gastric emptying, may exert this effect through various pathways. Thus, there is importance of exploring the potential additional benefit beyond reducing the glycemic response with the addition of fat.

The most typical ways in which pasta and rice are consumed are with the addition of oil or tomato sauce, and are recommended to be consumed in this way in the Mediterranean diet. Among many benefits, the Mediterranean diet has been demonstrated to reduce the risk of cardiovascular disease, improved glycemic control and is encouraged in many clinical guidelines globally for both cardiovascular risk reduction and for diabetes. Some studies have explored the differences in glycemic response of different carbohydrate foods consumed with the addition of fat demonstrating that the glycemic response is indeed reduced.However, the GI may remain of importance even when other means to reduce glycemic response are introduced.

The investigators therefore designed a randomized controlled crossover study to explore whether the addition of fat in the form of commonly consumed sauces which are recommended as part of a Mediterranean diet, affects the difference in glycemic response between a commonly consumed low GI and a higher GI carbohydrate food.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

The outcomes assessor will be unaware of the intervention associated with the samples being analyzed.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •generally healthy

排除标准

  • •BMI≥30kg/m2
  • •have any health conditions (including anemia and metabolic conditions such as hypertension, dyslipidemia, impaired glucose intolerance or diabetes)
  • •have celiac disease
  • •perform intense physical activity (LAF ≥2.10 - LARN 2014)
  • •currently taking any prescription medication for chronic diseases (including psychiatric)
  • •dietary supplements affecting the metabolism
  • •Women who are pregnant or breastfeeding

研究组 & 干预措施

Rice

Active Comparator

50 grams of available carbohydrate from white rice will be cooked according to package instructions and consumed as a test meal

干预措施: Rice (Other)

Glucose #1

Other

50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal

干预措施: Glucose #1 (Other)

Spaghetti

Active Comparator

50 grams of available carbohydrate from spaghetti will be cooked according to package instructions and consumed as a test meal

干预措施: Spaghetti (Other)

Spaghetti + tomato sauce

Active Comparator

50 grams of available carbohydrate from spaghetti plus tomato sauce (1:1 ratio) will be cooked according to package instructions and consumed as a test meal

干预措施: Spaghetti + Tomato Sauce (Other)

Rice + tomato sauce

Active Comparator

50 grams of available carbohydrate from white rice plus tomato sauce (1:1 ratio) will be cooked according to package instructions and consumed as a test meal

干预措施: Rice + Tomato Sauce (Other)

Spaghetti + Pesto

Active Comparator

50 grams of available carbohydrate from spaghetti plus pesto sauce (1:0.5 ratio) will be cooked according to package instructions and consumed as a test meal

干预措施: Spaghetti + Pesto (Other)

Rice + Pesto

Active Comparator

50 grams of available carbohydrate from white rice plus pesto sauce (1:0.5 ratio) will be cooked according to package instructions and consumed as a test meal

干预措施: Rice + Pesto (Other)

Glucose #2

Other

50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal

干预措施: Glucose #2 (Other)

Glucose #3

Other

50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal

干预措施: Glucose #3 (Other)

结局指标

主要结局

Glycemic Index

时间窗: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)

postprandial response for glucose (IAUC); Comparisons will be made between the spaghetti and rice IAUCs in each of the 3 contexts (alone, with tomato sauce, with pesto)

次要结局

  • Postprandial C-peptide(2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes))
  • Postprandial Insulin(2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes))
  • Peak Glucose(2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesca Scazzina Ph.D.

Assistant Professor

University of Parma

研究点 (1)

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