Randomized, Double-blind, Placebo-controlled Group, Single Center Study to Evaluate the Effect of 3 Months Policaptil Gel Retard Use on Postprandial Incretin Hormones Release and Satiety in Obese Women Regardless of Macronutrients Intake as Well as Body Mass Changes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evaluation of postprandial incretin axis activity
研究概览
简要总结
Randomized, double-blind, placebo-controlled study aimed at evaluating the effects of a 3-months treatment with Policaptil Gel Retard on postprandial incretin hormones release and satiety in obese women
详细描述
Double-blind, randomized, placebo-controlled, parallel-group study.
This study will in made of 3 phases:
- The assessment of standard dose (3 tablets) of Libramed or placebo on the incretin hormones release and satiety sensation in obese women after ingestion of four test meal administered with one day interval - run-in period, to assess incretin hormones release and satiety sensation in obese women
- A double-blind phase in which the treament with Libramed/Placebo will be administered for 3 months.
- A post (3-months) treatment assessment of the incretin hormones release and satiety sensation after ingestion of four test meals - follow-up period.
During the screening visit (V1, Week -1) patients will be evaluated with regard to the inclusion and exclusion criteria that will permit their entry into the run-in period. The results of the laboratory analyses such as lipids, glucose and insulin levels needed to check subjects' eligibility at the time of randomization [baseline visit (V2)] will be performed at the screening visit. The run-in period starts on day 2 of the menstrual cycle and ends not later than 12 days of menstrual cycle.
During the four visits of run-in period (V2, V3, V4 and V5) will be assessed the effect of double-blind single dose of Libramed or placebo on postprandial incretin axis activity, glucose and triglycerides levels, satiety feeling and subsequent food consumption in relation to macronutrients content in test meals intake. During the visit V2 patient will be trained on diary completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI 30.0-39.9 kg/m2,
- •serum fasting glucose and insulin in normal ranges (- glucose ≤ 100 mg/dl, insulin ≤ 15 uIU/ml)
- •HOMA-IR < 2.5 (normal range for insulin sensitivity among Polish population),
- •stable body mass in the last 3 months (not more than 2 kg),
- •do not use any hypocaloric diet in the last 6 months,
- •not changed then realized before physical activity in the last 3 months,
- •the lack of any known comorbidities,
- •do not use any drugs including contraceptive
- •capability to understand the study procedures and provide written informed consent.
排除标准
- •All chronic and acute disease of the digestive tract in medical history,
- •more than 3 alcoholic drinks per week (bear, glass of wine, and 50 ml vodka)
- •no patient co-operation.
结局指标
主要结局
Evaluation of postprandial incretin axis activity
时间窗: day 1 to day 91
incretin axis activity
Evaluation of postprandial glycemic profile
时间窗: day 1 to day 91
blood samples for glucose measurements ( will be collected on visits 1, 2, 3, 4 and 8, 9, 10, 11, 12 on the fasting state and during the postprandial 6-hours observations (6 time collections 1, 2, 3, 4, 5, 6 hours after the test meal intake).
Evaluation of triglycerides levels
时间窗: day 1 to day 91
Blood samples for triglycerides measurements will be collected on visits 1, 2, 3, 4 and 8, 9,10,11,12 on the fasting state and during the postprandial 6-hours observations (6 time collections 1, 2, 3, 4, 5, 6 hours after the test meal intake).
Evaluation of satiety feeling
时间窗: day 1 to day 91
On visit 2 and 8 the subjective fasting satiety and hunger sensation will be assessed on the basis of visual analogue scale (VAS) at the baseline (V2) and at the end of the double-blind treatment period (V8). In addition fasting and postprandial VAS scales will be filled by the test 5 minutes before Libramed product or placebo administration, 5 minutes before eating a test meal and 1, 2, 3, 4, 5, 6 hour after test meal consumption during the run-in period (V5) and follow-up period (V9-V12).
次要结局
- Evaluation of postprandial triglycerides - single dose assessment(day -6 to day 1)
- Waist circumference assessment(day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91)
- Evaluation of satiety feeling - single dose assessment(day -6 to day 1)
- Fasting insulin levels assessment(day 84 to day 91)
- Fasting lipids levels assessment(day 84 to day 91)
- Evaluation of postprandial glycemic profile - single dose assessment(day -6 to day 1)
- Evaluation of postprandial incretin axis activity - single dose assessment(day -6 to day 1)
- Body Mass assessment(day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91)
- Fasting incretin axis activity(day 84 to day 91)
- Evaluation of reduction in subsequent food consumption in relation to macronutrients content in test meals.(day -6 and day 84)
- Fat Mass assessment(day-7, day-6, day-4, day-2, day0, day28, day56, day84, day85, day87, day89, day91)
- Fasting glucose levels assessment(day 84 to day 91)
- Safety and tolerability(day -7 to day 91)