Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка LIMICOL® NG
  All subjects will consume 2 tablets per day during the entire intervention period, i.e. 12 weeks between V0 and V2, distributed as follows: 1 tablet in the morning at the end of or after breakfast (no taking on an empty stomach) and 1 tablet in the evening during dinner. If a dose is missed, 2 tablets can be taken at the next dose.

Первичные конечные точки

• Evolution over time (from 0 to 3 months) of the plasma concentration of LDL cholesterol [Срок оценки: To baseline at 3 months]

Вторичные конечные точки (12)

• Weight [Срок оценки: 0 month (baseline), 1 month, 3 months]
• Body Mass Index [Срок оценки: 0 month (baseline), 1 month, 3 months]
• Waist circumference [Срок оценки: 0 month (baseline), 1 month, 3 months]
• Blood pressure [Срок оценки: 0 month (baseline), 1 month, 3 months]
• Heart rate [Срок оценки: 0 month (baseline), 1 month, 3 months]
• Fasting glycemia [Срок оценки: 0 month (baseline), 1 month, 3 months]
• Lipid metabolism [Срок оценки: 0 month (baseline), 1 month, 3 months]
• Hepatic metabolism [Срок оценки: 0 month (baseline), 1 month, 3 months]
• Transaminases [Срок оценки: 0 month (baseline), 1 month, 3 months]
• Renal metabolism (Urea) [Срок оценки: 0 month (baseline), 1 month, 3 months]
• Renal metabolism (Creatinine Phophoskinase) [Срок оценки: 0 month (baseline), 1 month, 3 months]
• Renal metabolism (Lactate Deshydrogenase) [Срок оценки: 0 month (baseline), 1 month, 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• NutrInvest - Institut Pasteur de Lille — Lille

Идентификаторы

NCT: NCT06894251 · 2024-A01916-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗