Effect of the Intake of Specific Formulas for Diabetes With Sucromalt and Isomaltulose on the Glycemic Index, Insulin, Glucagon-like Peptide-1, Gastric Inhibitory Peptide Levels and Subjective Appetite in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Change from baseline Insulin at 180 minutes
研究概览
简要总结
Consumption of nutritional supplements with low glycemic carbohydrates induce favorable glycemic responses in subjects with type 2 diabetes. The aim of this study was to compare the effect of the intake of specific formulas for diabetes, with different types of carbohydrates (isomaltulose and sucromaltose) on the glycemic response, release of intestinal peptides and subjective appetite in Type 2 diabetic individuals. In a randomized, double-blind, cross-over study of 4 treatments, 16 subjects (56.60 ± 1.11 years). Fasting blood samples were taking, after that they were given to consume formula or reference product assigned randomly. Subsequently, samples of capillary and venous blood were obtained at times 30, 60, 90, 120 and 180 min, after the start of consumption of the experimental beverage for the measurement of glucose, insulin, gastric inhibitory peptide (GIP) and glucagon-like peptide-1 (GLP-1). The assessment of subjective appetite was measured by Visual Analogue Scale (VAS).
详细描述
This was a randomized, double-blind, cross-over study of 4 treatments that was conducted according to the Good Clinical Practice Guidelines, with all applicable Food and Drug privacy regulations, and ethical principles based on the Declaration of Helsinki. Participants signed informed consent, approved by the Human Research Ethics Committee of the Endocrine-Metabolic Research Center of the University of Zulia, in Venezuela. All selected subjects attended a first visit, in order to determine if they met the inclusion criteria, those who gathered them, were subjected to four consumption tests to determine the glycemic index (GI) and glycemic load (GL) and 3 consumption tests for the evaluation of subjective appetite. Each treatment or consumption session was carried out on different days.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 51 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes
- •Demonstrated use of oral hypoglycemic agents (metformin), for at least two months
- •BMI of 18.5 kg/m2 to ≤ 35 kg/m2
排除标准
- •Type 1 Diabetes
- •Diabetic ketoacidosis
- •Congestive heart failure
- •Gastric, renal or hepatic diseases
- •Myocardial infarction
- •Subjects with insulin therapy, antibiotic therapy or corticosteroids
- •End-stage organ failure
- •Individuals with organ transplantation
- •Coagulation or bleeding disorder
- •Infectious or chronic contagious disease (such as tuberculosis, hepatitis B or C or HIV).
研究组 & 干预措施
Ensure® Abbott Nutrition
A standard nutritional formula not specific for diabetics
干预措施: Ensure® Abbott Nutrition (Dietary Supplement)
Glucerna® Abbott Nutrition
A formula with a patented blend of slow-digesting carbohydrates including resistant maltodextrin and sucromalt
干预措施: Glucerna® Abbott Nutrition (Dietary Supplement)
Diasip® Nutricia Advanced
A formula whose composition has isomaltulose and resistant starch
干预措施: Diasip® Nutricia Advanced (Dietary Supplement)
Glicolab®
Glucose solution
干预措施: Glicolab® (Dietary Supplement)
结局指标
主要结局
Change from baseline Insulin at 180 minutes
时间窗: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
milliunits per liter (mU/L)
Change from baseline Glycemia at 180 minutes
时间窗: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
mmol/L
Glycemic Index (GI)
时间窗: 180 minutes after intake of each formula
Low GI (≤ 55), Intermediate (55-69) and High (≥70)
Glycemic Load (GL)
时间窗: 180 minutes after intake of each formula
High GL (\> 20), Intermediate GL (11-19) and Low GL (\<10)
Change from baseline GLP-1 at 180 minutes
时间窗: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
pmol/L
Change from baseline GIP at 180 minutes
时间窗: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
pg/mL
Change from baseline Hunger at 180 minutes
时间窗: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Visual Analogue Scale (mm)
Change from baseline Fullness at 180 minutes
时间窗: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Visual Analogue Scale (mm)
Change from baseline Desire to eat at 180 minutes
时间窗: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Visual Analogue Scale (mm)
Change from baseline Subjective appetite at 180 minutes
时间窗: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Visual Analogue Scale (mm)
Change from baseline Prospective food consumption at 180 minutes
时间窗: Minutes after intake of each formula: 0, 30, 60, 90, 120, 150, 180.
Visual Analogue Scale (mm)
次要结局
- HDL-C(Baseline)
- LDL-C(Baseline)
- Height(Baseline)
- Body Mass Index(Baseline)
- Total Cholesterol(Baseline)
- Age(Baseline)
- Triacylglycerides(Baseline)
- HbA1c(Baseline)
- Weight(Baseline)
- Hip Circumference(Baseline)
研究者
Daniel J Aparicio Camargo
Principal Investigator
Universidad del Zulia