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NOT YET RECRUITING
NCT06647108
NA

Food Supplement for Individuals with Metabolic Syndrome

Sponsor: ESI

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-01-10

Completion Date

2027-01

Last Updated

2024-10-17

Healthy Volunteers

No

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

Locations (1)

IRCCS AOU di Bologna

Bologna, Bologna, Italy