Isomaltulose VS Sucrose - Different Postprandial Effect on Incretin Profile and Determinants of the Second Meal Effect
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- disposition index
研究概览
简要总结
This study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as an determinant for the second meal effect.
In this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separate days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.
详细描述
Isomaltulose is a natural occurring disaccharide with a similar structure to sucrose. It is composed of glucose and fructose, but is linked by an α-1,6-glycosidic bond instead of α-1,2. Due to its binding, isomaltulose is slowly hydrolysed, which results in a rather weak postprandial glycemic-insulinemic response, accompanied by a minimal GIP secretion and a stimulated secretion of GLP-1. In addition, several studies have shown that the intake of foods with a low glycemic index, such as isomaltulose, tend to improve the metabolic reaction to a subsequent meal. As the exact mechanism of this "second meal effect" is still unknown, the investigators hypothesize that the modified release and action of GIP and GLP-1 are key players in regard to the described effects.Therefore, isomaltulose could be a suitable tool for reducing the risk of developing diabetes, obesity and CVD as well as improve blood glucose control in people with diabetes.
In summary, this study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as a determinant for the second meal effect.
In this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separated days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.
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
- Single (Participant)
盲法说明
participants were unaware of selected sugar intake prior to second meal
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for T2DM patients: insulin-independent
- •for healthy subjects: at least 1 component of the metabolic syndrom:
- •Body mass index (BMI) ≥ 30 kg/m²
- •Waist-hip ratio (WHR) ≥ 85 for women and ≥ 90 for men
- •hypertension
- •dyslipidemia
- •glucose / insulin intolerance
排除标准
- •medications: intake of medications which influence glucose metabolism
- •alcohol / drug abuse
- •physical diseases: endocrinological, malign, serious cardiovascular diseases
- •acute / chronic communicable disease
- •psychic diseases
结局指标
主要结局
disposition index
时间窗: 4 visits, separated by 1 week each
Alteration of the Insulin secretion due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved beta-cell response (Insulin secretion)
hepatic insulin extraction
时间窗: 4 visits, separated by 1 week each
Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved hepatic insulin extraction (secondary effect of improved Insulin sensitivity).
insulinogenic index
时间窗: 4 visits, separated by 1 week each
Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved second meal effect (Insulin sensitivity).
次要结局
- incretin response(4 visits, separated by 1 week each)
- inflammatory reaction(4 visits, separated by 1 week each)
- Lipid status(4 visits, separated by 1 week each)
- additional endocrine parameters(4 visits, separated by 1 week each)
研究者
Prof. Dr. med. Andreas F. H. Pfeiffer
Director (Dpt. Clinical Nutrition)
German Institute of Human Nutrition