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.
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: 1. increased waist circumference (WC) (as per population- and country-specific definition) 2. increased levels of triglycerides (TG) (≥ 150 mg/dL) 3. reduced high-density lipoprotein cholesterol (HDL-C) levels (\< 40 mg/dL in men and \< 50 mg/dL in women) 4. increased blood pressure (BP) (systolic BP≥ 130 mmHg and/or diastolic BP≥ 85 mmHg) 5. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
The composition of the dietary supplement is the following (for 1 sachet): 450 mg glucomannan, 250 mg white mulberry dry extract (d.e.), 200 mg gymnema (d.e.), 200 mg olive (d.e.), 200 mg Cassia nomame (d.e.), 200 mg Nopal, 5 mg policosanols and 20 µg chromium
Placebo
IRCCS AOU di Bologna
Bologna, Bologna, Italy
Effect of the Dietary Supplement on Apo B
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).
Time frame: From enrollment to the end of treatment at 12 weeks
Effect of the Dietary Supplement on changes in body water
To evaluate the effect of the dietary supplement on changes in body water compared baseline and placebo after 12 weeks of treatment.
Time frame: From enrollment to the end of treatment at 12 weeks
Effect of the Dietary Supplement on changes in lean body mass
To evaluate the effect of the dietary supplement on changes in lean body mass compared baseline and placebo after 12 weeks of treatment.
Time frame: From enrollment to the end of treatment at 12 weeks
Effect of the Dietary Supplement on changes in fat body mass
To evaluate the effect of the dietary supplement on changes in fat body mass compared baseline and placebo after 12 weeks of treatment.
Time frame: From enrollment to the end of treatment at 12 weeks
Effect of the Dietary Supplement on changes in waist circumference
To evaluate the effect of the dietary supplement on changes in waist circumference compared baseline and placebo after 12 weeks of treatment.
Time frame: From enrollment to the end of treatment at 12 weeks
Dietary Supplement use and prevalence of Metabolic Syndrome
To verify whether the intake of the dietary supplement is associated with a reduction in the prevalence of metabolic syndrome, compared to baseline and compared to placebo, after 12 weeks of treatment.
Time frame: From enrollment to the end of treatment at 12 weeks
Effect of the Dietary Supplement on changes in body water midway through the study
To evaluate the effect of the dietary supplement on changes in body water compared baseline and placebo after 6 weeks of treatment
Time frame: From enrollment to 6-week follow-up
Effect of the Dietary Supplement on changes in lean body mass midway through the study
To evaluate the effect of the dietary supplement on changes in lean body mass compared baseline and placebo after 6 weeks of treatment.
Time frame: 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
To evaluate the effect of the dietary supplement on changes in fat body mass compared baseline and placebo after 6 weeks of treatment.
Time frame: From enrollment to 6-week follow-up
Effect of the Dietary Supplement on changes in waist circumference effect on cholesterol midway through the study
To evaluate the effect of the dietary supplement on changes in waist circumference compared baseline and placebo after 6 weeks of treatment.
Time frame: From enrollment to 6-week follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.