NCT06704321招募中不适用
A Parallel, Randomized, Placebo-Controlled, Double-Blinded Clinical Trial of the Effects of TOTUM-448 on Liver Fat Content, Cardiometabolic Risk Factors and Gut Microbiota Among Both Men and Women with MASLD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Valbiotis
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Evolution of liver fat content
研究概览
简要总结
This clinical trial aims to investigate the effects of TOTUM-448, a mix of 5 plant extracts and choline, consumed at the daily regimen of two times per day, on liver fat content, cardiometabolic risk factors and gut microbiota among both men and women with MASLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Men and women aged between 18 and 75 years (including ranges);
- •CAP Score ≥288dB/m with liver stiffness results <8kPa (corresponding to F0 to F1 fibrosis score) assessed by Fibroscan®;
- •BMI ≥25 and <40 kg/m2 and WC thresholds according to the NAFLD Nomenclature consensus group (Rinella.
- •Hepatology);
- •Weight stable within ± 5% in the last three months.
排除标准
- •Contraindications to MRI, Fibroscan® and DEXA;
- •Suffering from a metabolic disorder susceptible to significantly affect glucose metabolism or plasma lipid levels or that might affect the study outcomes according to the investigator;
- •Suffering from an uncontrolled arterial hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
- •With a history of atherosclerotic cardiovascular disease (ASCVD);
- •Taking medication which may affect the study outcomes;
- •Alcohol consumption over ≥10 drinks/week for women and ≥15 drinks/week for men (women consuming more than 3 drinks/day and men consuming more than 4 drinks/day will also be excluded) or not agreeing to keep their alcohol consumption habits unchanged throughout the study.
结局指标
主要结局
Evolution of liver fat content
时间窗: Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3)
Liver fat content measured by MRI
次要结局
- Evolution of lipid profile(Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3))
- Evolution of glucose homeostasis(Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3))
- Evolution of liver health(Screening (V0), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3))
- Evolution of inflammation(Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3))
- Evolution of anthropometric variables(Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3))
- Evolution of body composition(Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3))
- Evolution of health-related quality of life(Baseline (V1) and End of supplementation after 16 weeks of supplementation (V3))
- Evolution of hepatic function(Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3))
- Evolution of kidney function(Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3))
- Evolution of hemodynamic measurements(Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3))
- Evolution of complete blood count(Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3))
- Evolution of thyroid stimulating hormone(Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3))
- Evolution of adverse events (TEAE, STEAE, TEAE leading to investigational product discontinuation, TEAR)(Screening (V0), Baseline (V1), Following 8 weeks of supplementation (V2) and End of supplementation after 16 weeks of supplementation (V3))
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood PressurePrehypertensionElevated Blood PressureBlood PressureMetabolic SyndromeNCT05469503Valbiotis410
已完成
不适用
Effect of Totum-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia (REVERSE-IT)Prediabetic StateDiabetes type2DysglycemiaNCT04423302Valbiotis636
已完成
不适用
Effect of Totum-070 on Lipid Metabolism in Moderate Hypercholesterolemic SubjectsHypercholesterolemiaCardiovascular Risk FactorDyslipidemiasOverweight and ObesityAtherosclerosisNCT04760951Valbiotis120
已完成
不适用
Mode of Action (MoA) Study of TOTUM-63 in Individuals at Increased Cardio-metabolic RiskPrediabetic StateDysglycemiaOverweight and ObesityNCT05369585Valbiotis20
Unknown
不适用
Effect of the Food Supplement TOTUM-070 on Lipid MetabolismHypercholesterolemiaNCT06243484Valbiotis180