Food Supplement: 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: Placebo
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Effect of the Dietary Supplement on Apo B — 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).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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