Lipidrive Dietary Supplement Tolerance Study Based on Blood, Urine, and Hemodynamic Biological Parameters.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Valbiotis
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in fasting HOMA-IR
研究概览
简要总结
The objectives of this clinical study are to determine the tolerance of dietary supplement Lipidrive through the evaluation of several parameters :
- Various blood biological parameters
- Urinary parameters
- Hemodynamic indicators
- Cardiac function
- Anthropometric variables
详细描述
Primary objectives of this study :
Evaluate the effects of two doses of the product on:
- Various blood biological parameters for tolerance (preprandial): blood glucose, insulin, HOMA-IR, glycated hemoglobin, fructosamine, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT, alkaline phosphatase, bilirubin, urea.
- Urinary parameters: urea, creatinine.
- Hemodynamic indicators: heart rate and blood pressure.
- Cardiac function: ECG.
- Anthropometric variables: weight, waist, hips, waist/hip ratio, body composition using bioelectric impendence analysis.
Secondary objectives of this study:
Evaluate the effects of the highest dose on:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged 45 to 65 years (inclusive)
- •BMI between 30 kg/m² (inclusive) and 40 kg/m² (non-inclusive) and/or a waist/hips ratio > 0.9
- •Non-smoker or smokes maximum 10 cigarettes per day
- •Stable weight for at least 3 months before the start of the study
- •Regular physical activity for 3 months before the start of the study, subject agreeing to maintain this level of activity over the course of the study
- •Stable eating habits for 3 months before the start of the study, subject agreeing to maintain these eating habits over the course of the study
- •Willing and able to comply with the protocol, subject agreeing to give their informed written consent
- •Registered with a social security scheme
- •Subject agreeing to be registered in the national directory of volunteers participating in biomedical research
- •Following the biological screening conducted during the inclusion visit, run-in subjects will be included at the following visit according to the following criteria:
- •FBC with no clinically significant anomalies according to the investigator
- •ASAT ≤ 1.55 μkat/L or ≤ 92 U/L
- •ALAT ≤ 1.7 μkat/L or ≤ 101 U/L
- •gGT ≤ 2.55 μkat/L or ≤ 152 U/L
- •45 ≤ Creatinine ≤ 104 μmol/L (± 10%)
- •Total bilirubin < 17.1 μmol/L (± 10%)
- •1.7 mmol/L ≤ Urea ≤ 8.3 mmol/L (± 10%)
- •us-CRP ≤ 5 mg/L (± 10%).
排除标准
- •Confirmed or suspected food allergy to the test product (describe)
- •Subject with chronic condition or specific circumstances that the investigator considers incompatible with participation in the study
- •Subject taking anti-diabetic treatment
- •Subject taking lipo-regulating (fibrates, statins, nicotinic acid) or anti-dyslipidemia drugs
- •Subject consuming dietary supplements (V0 could be conducted at least 1 month after completely stopping the supplements)
- •Subject consuming grapefruit or orange juice (enzyme inhibitor)
- •Subject consuming food products supplemented with phytosterols, beta glucans, konjac, and/or cinnamon (V0 could be conducted at least 3 months after completely stopping the supplements) (list to be drawn up at the time of the study)
- •Unstable blood pressure equal to or over 160/95
- •Subject undergoing treatment that, according to the investigator, could interfere with the evaluation of the study criteria
- •Subject who has been on a low-calorie diet in the 3 months prior to the study and/or intends to go on a diet during the study
- •Subject with serious history of anorexia nervosa, bulimia or other eating disorders
- •Vegetarian or vegan
- •Extreme eating habits
- •Subject participating in another clinical study or in an exclusion period following a previous clinical study
- •Subject who has received over 4500 euros in compensation since the start of the calendar year (sum can vary according to regulations)
- •Subject with a linguistic or physical incapacity to provide written informed consent
- •Refusal to provide written consent
- •Subject deprived of liberty by administrative or judicial order, under trusteeship or guardianship
- •Subject who cannot be contacted by telephone in case of emergency
研究组 & 干预措施
Lipidrive
Dose 1 : 2,6 g (4 capsules) Lipidrive per day during 12 weeks Dose 2 : 5,2 g (8 capsules) Lipidrive per day during 12 weeks, 2 weeks (wash-out period) between the 2 doses
干预措施: Lipidrive (Dietary Supplement)
结局指标
主要结局
Changes in fasting HOMA-IR
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks)
Changes in fasting blood glucose
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L
Changes in fasting insulinemia
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mUI/L
Changes in glycated hemoglobin
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in %
Changes in fasting fructosamin
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in µmol/L
Changes in fasting total cholesterol
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L
Changes in fasting HDL cholesterol
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L
Changes in fasting LDL cholesterol
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L
Changes in oxidized LDL
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L
Changes in us-CRP
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L
Changes in blood creatinine
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mg/dL
Changes in fasting blood levels of ASAT (Aspartate aminotransferase) and ALAT (Alanine aminotransferase)
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in UI/L
Changes in fasting triglycerides
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmol/L
Changes in fasting blood levels of GGT (Gamma glutamyltransferase)
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in UI/L
Changes in fasting alkaline phosphatase
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in UI/L
Changes in fasting blood bilirubin
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in µmol/L
Changes in fasting blood urea
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mg/dL
Changes in heart rate
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in bpm
Changes in SBP (systolic blood pressure) and DBP (diastolic blood pressure)
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in mmHg (mean of the two measures for each parameter at each visit)
Changes in cardiac function (electrocardiogram, ECG)
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks)
Changes in body weight
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks) in kg
Changes in WC (waist circumference)
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks)
Changes in HC (hip circumference)
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks)
Changes in WHR (waist to hip ratio)
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks)
Changes in body composition
时间窗: 26 weeks
Defined as the difference V5 (26 weeks) - V4 (14 weeks), using bioelectric impendence analysis
次要结局
- Changes in fasting blood adiponectin(26 weeks)
- Changes in fasting blood leptin(26 weeks)
- Changes in the evolution of glycemia during an oral glucid tolerance test(26 weeks)
- Changes in the incremental area under the curve (glycemia response) during an oral glucid tolerance test(26 weeks)
- Changes in the glycemia Cmax during an oral glucid tolerance test(26 weeks)
- Changes in the glycemia Δpeak during an oral glucid tolerance test(26 weeks)
- Changes in the evolution of insulinemia during an oral glucid tolerance test(26 weeks)
- Changes in the incremental area under the curve (insulinemia response) during an oral glucid tolerance test(26 weeks)
- Changes in the insulinemia Cmax during an oral glucid tolerance test(26 weeks)
- Changes in the insulinemia Δpeak during an oral glucid tolerance test(26 weeks)