Evaluation of Postprandial Glycemia After Eating a Pasta Dish Made With Resistant Starch.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Baseline blood glucose
研究概览
简要总结
Resistant starch partially resists hydrolyzation by digestive enzymes in humans. Consequently, it is not absorbed in the small intestine and goes directly to the large intestine, where it is fermented by the intestinal microbiota, acting as a prebiotic and stimulating the growth of beneficial bacteria in the colon. In addition, the effect of resistant starch on postprandial glucose metabolism is studying. Thus, the present research on healthy subjects has been proposed.
The main objective is to assess the effect on postprandial glycemia of eating a pasta dish made with resistant starch versus its original version.
For this purpose, a randomized, double blind crossover study has been designed.
Target sample size is 18 subjects.
详细描述
The arms of the study are two:
- Experimental group (pasta dish made with resistant starch).
- Control group (original pasta dish).
Volunteers who wish to participate in the study will be interviewed by phone to verify that they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts. Volunteers who agree to participate in the study will sign the informed consent and will be randomly assigned to one of the two arms of the study.
The two visits (clinical investigation days) of the study will take place with the volunteers in a fasting state of 4 hours and separated by at least 1 week washout period. The day before the visit, volunteers won't be able to drink alcohol, drink and eat excessively, and/or sleep few hours. Both visits will consist of eating a pasta dish in a maximum of 15 minutes. Blood samples will be taken before eating and during the 2.5 hours after (30, 60, 90, 120 and 150 minutes), in order to analyze the evolution of blood glucose and insulin levels.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The products (experimental and placebo), will be produced by an external producer, who will retain the codes. None of the researchers involved in the study development or analyses will know the association until the end of the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-65 years.
- •Body mass index: 18.5-29.9 kg/m2
- •Volunteers who like and feel good with the ingredients of the dish.
- •Good physical and psychological state.
- •Volunteers undergoing pharmacological treatment will be maintained if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function or glucose metabolism.
- •Subjects must be able to understand and be willing to sign the informed consent, and must comply with all the procedures and requirements of the study.
- •No weight variations considered relevant (+/- 3kg) in the last 3 months.
排除标准
- •Subjects with relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux, etc.
- •Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
- •Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).
- •Women who are breastfeeding or pregnant.
- •Subjects with liver disease.
- •Subjects with some type of cancer or undergoing treatment for it, or who have not had a period of at least 5 years since its eradication.
- •Subjects with allergies to any component of the product under study or any other food that interferes and makes it difficult to monitor the study.
- •Subjects who present some type of cognitive and/or psychic impairment.
- •Subjects in whom poor collaboration is expected or who, in the opinion of the investigator, have difficulties in following the study procedures.
- •Subjects who work the night shift.
- •Subjects who follow some type of supplementation that interferes with the study.
- •Subjects who are immersed in some treatment for weight loss.
结局指标
主要结局
Baseline blood glucose
时间窗: 0 min in the Clinical investigation day 1 and Clinical investigation day 2 (at least 7 days after the clinical investigation day 1)
Blood glucose levels before start eating the pasta dish in each clinical investigation day will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Postprandial blood glucose
时间窗: 30, 60, 90, 120 and 150 min after start eating the pasta dish in the Clinical investigation day 1 and Clinical investigation day 2
Blood glucose levels after start eating the pasta dish in each clinical investigation day will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Glycemia Area Under the Curve
时间窗: Baseline, 30, 60, 90, 120 and 150 minutes in the Clinical investigation day 1 and Clinical investigation day 2
Postprandial glycemia levels after eating pasta dish in each clinical investigation day will be analyzed biochemical autoanalyzer and reported in mg/dL. Glycemia AUC will be calculated by the trapezoidal rule.
次要结局
- Acceptance of pasta dish(Clinical Investigation Day 1 (after eat the pasta dish) and Clinical Investigation Day 2 (after eat the pasta dish))
- Body mass index(Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish))
- Baseline blood insulin(0 min in the Clinical investigation day 1 and Clinical investigation day 2)
- Body weight(Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish))
- Postprandial blood insulin(30, 60, 90, 120 and 150 min after start eating in the Clinical investigation day 1 and Clinical investigation day 2.)
- Insulinemia Area Under the Curve(Baseline, 30, 60, 90, 120 and 150 minutes in Clinical investigation day 1 and Clinical investigation day 2)
- Height(Clinical Investigation Day 1 (before eat the pasta dish) and Clinical Investigation Day 2 (before eat the pasta dish))