Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effect of a Food Supplement on Apolipoprotein B in Individuals with Metabolic Syndrome Adhering to the Mediterranean Diet
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ESI
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Effect of the Dietary Supplement on Apo B
研究概览
简要总结
In metabolic syndrome, blood levels of apolipoprotein B (Apo B) reveal the presence of quantitative and qualitative alterations of atherogenic lipoproteins and therefore represent an indicator of the risk of developing cardiovascular disease (CVD). The objective of this study is to evaluate the effect of a combined dietary supplement containing glucomannan, white mulberry dry extract (d.e.), gymnema (d.e.), olive (d.e.), Cassia nomame (d.e.), Nopal, policosanols and chromium, compared to placebo, on Apo B in individuals with metabolic syndrome adhering to the Mediterranean diet. Furthermore, the effect of the dietary supplement on anthropometric parameters, waist circumference and body composition will be investigated.
详细描述
Metabolic syndrome is a highly prevalent condition characterized by the simultaneous presence of multiple cardiometabolic risk factors, such as arterial hypertension, atherogenic dyslipidemia, hyperglycemia and abdominal obesity. According to the International Atherosclerosis Society (IAS), metabolic syndrome is a clustering of at least three of the following five medical conditions:
- increased waist circumference (WC) (as per population- and country-specific definition)
- increased levels of triglycerides (TG) (≥ 150 mg/dL)
- reduced high-density lipoprotein cholesterol (HDL-C) levels (< 40 mg/dL in men and < 50 mg/dL in women)
- increased blood pressure (BP) (systolic BP≥ 130 mmHg and/or diastolic BP≥ 85 mmHg)
- impaired fasting glucose [fasting plasma glucose (FPG)≥ 100 mg/dL] In metabolic syndrome, blood levels of apolipoprotein B (Apo B) reveal the presence of quantitative and qualitative alterations of atherogenic lipoproteins and therefore represent an indicator of the risk of developing cardiovascular disease (CVD).
Troubling increases in high FPG, high body mass index (BMI), and other risk factors related to obesity and metabolic syndrome indicate an urgent need to identify and implement interventions, as shown by the Global Burden of Disease (GBD) Study Group. To date, several active ingredients of natural origin have been shown to favorably modify the individual components that have revealed the presence of metabolic syndrome. Among these, we find glucomannan and white mulberry dry extract.
The purpose of this study is to evaluate if a dietary supplement containing glucomannan, white mulberry dry extract (d.e.), gymnema (d.e.), olive (d.e.), Cassia nomame (d.e.), Nopal, policosanols and chromium, is able to significantly influence serum levels of apo B in individuals with metabolic syndrome adhering to the Mediterranean diet. Furthermore, the effect of the dietary supplement on anthropometric parameters, waist circumference and body composition will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Male or female aged ≥ 18 years and ≤ 70 years old;
- •Subjects with metabolic syndrome (according to the IAS criteria);
- •Subjects with an estimated 10-year risk of CVD< 10% (as per the SCORE risk prediction algorithm of the ESC)
- •Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements;
- •Subjects agree to participate in the study and having dated and signed the informed consent form
排除标准
- •Treatment with lipid-lowering drugs or taking food supplements that are effective on blood lipid levels;
- •Chronic pharmacological treatments for any clinical condition not stabilized for at least 3 months;
- •Known alterations in thyroid, renal or hepatic function (including transaminase values ≥ 3 times the times the upper limit of the normal range (ULN));
- •Present or previous alcohol abuse;
- •Pregnancy and breastfeeding;
- •Subjects with known intolerance to one of the components of the tested dietary supplement;
- •History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study.
结局指标
主要结局
Effect of the Dietary Supplement on Apo B
时间窗: From enrollment to the end of treatment at 12 weeks
The primary objective is to compare the effect on Apo B after 12 weeks of treatment with the dietary supplement or placebo, in combination with the Mediterranean diet (Standard of Care - SOC).
次要结局
- Effect of the Dietary Supplement on changes in body water(From enrollment to the end of treatment at 12 weeks)
- Effect of the Dietary Supplement on changes in lean body mass(From enrollment to the end of treatment at 12 weeks)
- Effect of the Dietary Supplement on changes in fat body mass(From enrollment to the end of treatment at 12 weeks)
- Effect of the Dietary Supplement on changes in waist circumference(From enrollment to the end of treatment at 12 weeks)
- Dietary Supplement use and prevalence of Metabolic Syndrome(From enrollment to the end of treatment at 12 weeks)
- Effect of the Dietary Supplement on changes in body water midway through the study(From enrollment to 6-week follow-up)
- Effect of the Dietary Supplement on changes in lean body mass midway through the study(From enrollment to 6-week follow-up)
- Effect of the Dietary Supplement on changes in fat body mass effect on cholesterol midway through the study(From enrollment to 6-week follow-up)
- Effect of the Dietary Supplement on changes in waist circumference effect on cholesterol midway through the study(From enrollment to 6-week follow-up)