Impact of High Protein and Low Carbohydrate Smoothie Drinks Versus Diabetes-specific Nutritional Formulas on Postprandial Glucose Homeostasis in Type-2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Change from baseline Glycemia at 240 minutes
研究概览
简要总结
We compared between a regular high protein or a high protein and low carbohydrate smoothie drinks with conventional diabetic enteral drinks (Glucerna) on glucose homeostasis, insulin and lipid metabolism in type 2 diabetic and obese individuals.
详细描述
We aimed to determine the effect of high protein and low carbohydrate smoothie drinks on glucose homeostasis, insulin and lipid metabolism in type 2 diabetic and obese individuals. We compared between a regular high protein or a high protein and low carbohydrate smoothie drinks with conventional diabetic enteral drinks (Glucerna). A crossover design study was done in 60 diabetic participants. Participants consumed 300 kilocalories of each drink at a time with one week wash out period between drinks and glucose response curves at baseline, 30, 60, 90, 120, 180 and 240 minutes were monitored and compared. The products were formulated to supply 1 kilocalorie/milliliter (kcal/ml). Dietary compositions in regular formulas (smoothie, SM) were 30-40% carbohydrate, 20-30% protein and 30-50% fat. While in smoothie with low carbohydrate formulas (SMLS), they were 25-35% carbohydrate, 25-30% protein and 35-55% fat vs. a control formula (Glucerna).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •people with type 2 diabetes mellitus or use blood glucose-lowering drugs more than 3 months
- •BMI > 25 kg/m^2
- •HbA1c 6.5 - 8.5
- •use stable level of blood glucose-lowering drugs and blood lipid-lowering drugs more than 3 months
排除标准
- •pregnancy or breastfeeding
- •people with chronic diseases or tube feeding or dysphagia i.e. pneumonia
- •people with insulin injection or use GLP-1 analogues drugs or DPP-4 inhibitors drugs
- •people with history of bariatric surgery, gastroparesis, malabsorption
- •people with history of diseases that affect blood glucose/lipid control i.e. hyperthyroidism, endocrinology and kidney disorders
- •use long-term immunosuppressants
- •cancer patient
研究组 & 干预措施
smoothie with regular formulas (SM)
Participants were given 300 kcal smoothie with regular formulas within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes.
干预措施: smoothie with regular formulas (SM) (Dietary Supplement)
smoothie with low carbohydrate formulas (SMLS)
Participants were given 300 kcal smoothie with low carbohydrate formulas within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes.
干预措施: smoothie with low carbohydrate formulas (SMLS) (Dietary Supplement)
conventional diabetic enteral drinks (Glucerna)
Participants were given 300 kcal Glucerna within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes.
干预措施: conventional diabetic enteral drinks (Glucerna) (Dietary Supplement)
结局指标
主要结局
Change from baseline Glycemia at 240 minutes
时间窗: Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240
glucose (mg/dl)
Change from baseline Insulin at 240 minutes
时间窗: Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240
insulin (μU/ml)
次要结局
- Age(Baseline)
- Weight(Baseline)
- Height(Baseline)
- Body Mass Index(Baseline)
- Waist circumference(Baseline)
- Blood pressure(Baseline)
- Complete Blood Count (CBC)(Baseline)
- glycosylated hemoglobin (HbA1C)(Baseline)
- liver aminotransferaces activity - Serum glutamate oxaloacetate transaminase (SGOT)(Baseline)
- liver aminotransferaces activity - Serum glutamate pyruvate transaminase (SGPT)(Baseline)
- lipid profiles concentration analysis(Baseline)
- Creatinine concentration analysis(Baseline)