NCT06647108

Food Supplement for Individuals with Metabolic Syndrome

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: ESI · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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
OTHER	Placebo	Placebo

Timeline

• Start date: 2025-01-10
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-10-17
• Last updated: 2024-10-17

Locations

1 site across 1 country: Italy