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Food Supplement for Individuals with Metabolic Syndrome

NCT06647108 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-17

No results posted yet for this 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.

Conditions

  • Metabolic Syndrome

Interventions

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

Sponsors & Collaborators

  • ESI

    lead INDUSTRY

Principal Investigators

  • Arrigo Francesco Giuseppe Cicero, MD, PhD · University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06647108 on ClinicalTrials.gov