A Single-blind, Parallel-group, Randomized, Placebo-controlled Clinical Trial, to Evaluate the Effects of Two Different Formulations of a Dietary Supplement on the Lipid Profile in Subjects with Mild Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment
研究概览
简要总结
A single-center, randomized, parallel-group, double-blind, placebo-controlled clinical study followed by an open-label phase to evaluate the effects of a new formulation of a supplement on lipid profile in subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet.
The study population consists of 99 subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet. The participants will be divided into three groups:
Group A: Test Product A (study product) Group B: Test Product B (comparative product) Placebo group: placebo
The following visits are scheduled during the study:
T-2 (day -35) - Screening visit, 5 weeks before T0 T-1 (day -28) - Enrollment visit, 4 weeks before T0 T0 (day 0) - Randomization visit, baseline T1 (day 56) - Interim visit, 8 weeks after T0 T2 (day 112) - Final visit, 16 weeks after T0 After the first 8 weeks of the study (double-blind), all three groups will continue with only Product A for an additional 8 weeks. This experimental design aims to highlight whether any differences between Test Product A and Test Product B observed during the first 8 weeks can be minimized when both arms receive the same treatment. Additionally, the effect of Product A will be observed at 8 and 16 weeks, thus providing efficacy data over a longer treatment period. This may also provide insights into the potential achievement of a plateau. Regarding the placebo group, it will be possible to distinguish the effect of the diet alone from the combined effect of the diet and supplementation with Test Product A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prevention of cardiovascular disease
- •Low cardiovascular risk (< 5%)
- •Sub-optimal serum levels of LDL-C (130-136 mg/dl; 3.37-4.14 mmol/l) and/or non-HDL-C (160-190 mg/dl; 4.14-4.92 mmol/l) at T-2
- •Signature of informed consent.
排除标准
- •Patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk >/= 5)
- •diabetes mellitus
- •Taking hypolipemiants, supplements or drugs that may involve lipid metabolism
- •Hypertension treatment not stabilized for at least 3 months
- •History of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease
- •Any medical-surgical treatment that may limit adherence to the study protocol
- •Pregnant and/or breastfeeding women
结局指标
主要结局
Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment
时间窗: At baseline (T0) and at 8 weeks.
Evaluation of absolute value change in Low-Density Lipoprotein Cholesterol (LDL-C) serum concentration (expressed as mg/dL), at 8 weeks (T1) of dietary supplementation with Test Product A vs baseline (T0).
次要结局
- Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B(At baseline (T0), and at 8 weeks (T1))
- Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Low-Density Lipoprotein Cholesterol (LDL-C)(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- High-Density Lipoprotein Cholesterol (HDL-C)(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Flow-Mediated Dilation (FMD) - Endothelial Function(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Serum Uric Acid(At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2))
- Creatinine Concentration(At baseline (T0), 8 weeks (T1) and 16 weeks (T2).)
- Creatine phosphokinase (CPK) Concentration(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Number of subjects with LDL-C normal concentration(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Cardiovascular Risk (CV)(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Patients' compliance with the treatment(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Patients' Tolerability of the assigned treatment(At 8 weeks (T1) and at 16 weeks (T2))
- Patient acceptability of the assigned treatment(At 8 weeks (T1) and at 16 weeks (T2))
- Patients' adherence to diet(Baseline (T0), 8 weeks (T1), 16 weeks (T2))
- Implementation of patients' lifestyle(At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2))
- Monitoring of adverse events(Through study completion, an average of 1 year)
- Body Weight(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Body Mass Index (BMI)(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Apolipoprotein B(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Serum Total Cholesterol Concentration (TC)(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Non High-Density Lipoprotein Cholesterol (Non-HDL-C)(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Triglycerides (TG)(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Systolic Blood Pressure(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Diastolic Blood Pressure(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Pulse Pressure(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Mean Arterial Pressure(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Glutamic Oxaloacetic Transaminase (GOT)(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Gamma-Glutamyl Transferase (Gamma - GT)(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Glutamic Pyruvate Transaminase (GPT)(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))
- Fasting Blood Glucose Concentration(At baseline (T0), 8 weeks (T1), and 16 weeks (T2))