NCT06894251招募中不适用
Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Evolution over time (from 0 to 3 months) of the plasma concentration of LDL cholesterol
研究概览
简要总结
The goal of this clinical trial is to observe a decrease in plasma LDL cholesterol concentration of 10% (or 0.20g/L) in subjects with untreated moderate hypercholesterolemia after 3 months of consumption of the Limicol®-NG food supplement, compared with a historical placebo group
详细描述
The objective is to evaluate the effect of the Limicol®-NG food supplement during the 3 months of taking it (after 1 and 3 months of consumption versus T0) and comparison versus placebo history of the evolution over time (from 0 to 3 months) of the following parameters:
- Weight,
- BMI,
- Waist circumference,
- Systolic and diastolic blood pressures,
- Resting heart rate.
- Fasting blood sugar
- LDL cholesterol
- Non-HDL cholesterol (NHC)
- Total cholesterol (TC)
- HDL cholesterol
- Triglycerides (TG)
- LDL/HDL and TC/HDL ratios,
- Safety parameters measured from blood samples at VS and V2: ASAT, ALAT, Gamma-GT, Creatine Kinase, Lactate DeHydrogenase, Bilirubin, Creatinine, and Urea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For women
- •If pre-menopausal: effective non-estrogenic contraception established for at least 2 cycles, to be maintained during the study,
- •If menopausal: without estrogenic Hormone Replacement Therapy (HRT)
- •LDL cholesterol >1.3 g/L (according to Friedewald calculation);
- •Having stable eating habits, a level of physical activity and a weight for at least 3 months before the start of the study;
- •Agreeing to maintain their lifestyle habits throughout the duration of the study;
- •Agreeing to follow the constraints generated by the study;
- •Having signed the informed consent form;
- •Social security insured.
排除标准
- •Subjects receiving hypolipidemic or anti-dyslipidemic treatment (statin, ezetimibe, cholestyramine, fibrate, etc.)
- •Subjects presenting triglyceridemia > 4g/L (Friedewald)
- •Subject requiring immediate treatment with statin
- •Subject requiring immediate dietary intervention or having fluctuating eating behavior
- •Diabetic subjects treated or not with medication
- •Subjects with unstable treatment (for less than three months), or requiring the implementation of treatment during the study which, according to the investigator, could interfere with the evaluation of the study criteria (efficacy: LDL, TG, HDL, blood sugar, blood pressure, weight; safety: markers of liver, muscle or kidney function)
- •Subjects who have consumed in the last 3 months food supplements or functional foods that could impact cholesterol or TG levels (phytosterol, phytostanol, red yeast rice, policosanols, beta-glucans at a dose greater than 3 g/day, probiotics)
- •Subjects suffering from a severe chronic condition deemed incompatible with the study by the investigator (serious digestive pathologies, renal failure, coronary pathology, immunodeficiency, heart failure, rhythm disorders, progressive tumor pathology, blood disease)
- •Subject suffering from a severe eating disorder (anorexia, bulimia, binge eating disorder)
- •Pregnant woman or planning to become pregnant during the study period or breastfeeding
- •Whose state of health or concomitant treatments are judged by the principal investigator or a qualified co-investigator to be incompatible with the proper conduct of the clinical study.
结局指标
主要结局
Evolution over time (from 0 to 3 months) of the plasma concentration of LDL cholesterol
时间窗: To baseline at 3 months
Historical placebo comparison of the evolution over time (from 0 to 3 months) of plasma LDL cholesterol concentration measured according to the Friedwald method (in g/L and %).
次要结局
- Weight(0 month (baseline), 1 month, 3 months)
- Body Mass Index(0 month (baseline), 1 month, 3 months)
- Waist circumference(0 month (baseline), 1 month, 3 months)
- Blood pressure(0 month (baseline), 1 month, 3 months)
- Lipid metabolism(0 month (baseline), 1 month, 3 months)
- Heart rate(0 month (baseline), 1 month, 3 months)
- Transaminases(0 month (baseline), 1 month, 3 months)
- Fasting glycemia(0 month (baseline), 1 month, 3 months)
- Hepatic metabolism(0 month (baseline), 1 month, 3 months)
- Renal metabolism (Urea)(0 month (baseline), 1 month, 3 months)
- Renal metabolism (Creatinine Phophoskinase)(0 month (baseline), 1 month, 3 months)
- Renal metabolism (Lactate Deshydrogenase)(0 month (baseline), 1 month, 3 months)
研究者
Coralie BERTHIER
Principal Investigator
Institut Pasteur de Lille
研究点 (2)
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