CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 162 enrolled
Drug / intervention
Composition with Silymarin +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04810572
NCT04810572N/ACompleted

Evaluation of the Effects of a Nutraceutical Composition Containing Derivatives From Natural Products on the Modulation of the Endocrine Neuroimmune Axis - Translational Study.

University of Sao Paulo General Hospital·interventional·Posted Mar 23, 2021·Updated Feb 1, 2024

In Brief

A clinical study evaluating Composition with Silymarin and Low-mineral composition without Silymarin for Insulin Resistance and 3 related conditions. Completed, enrolled 162 participants across 1 site.

Detailed Summary

The use of natural products in the prevention or treatment of chronic diseases is an emerging field in current medicine. And studying the mechanisms of actions by which natural products act in our bodies contributes to the rational use of these products. And the combination of different natural products such as prebiotics (FOS- fructooligosaccharides, GOS-Galactooligosaccharides and beta-glucans derived from yeast), herbal medicine (Silybum marianum), and minerals (Se-selenium, Zn-Zinc, and Mg-Magnesium), o which would result in a synergistic association between them can contribute to achieving not only preventive effects but treatment for chronic diseases such as diabetes and obesity. The present study aims to study the effects of a composition containing natural products on factors and markers that are part of mitochondrial biogenesis and the neuroimmune-endocrine system in healthy volunteers and that present grade 1 overweight/obesity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 23, 2021
Enrollment StartMay 20, 2021
Primary CompletionMay 20, 2022
Study CompletionDec 19, 2022
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 5.3 years ago

Interventions

Composition with Silymarindietary

Volunteers will receive supplementation for 180 days. They took 4 capsules daily. Two capsules in the morning and two capsules at night. There will be blood and feces collection at zero time, before supplementation, after 30, 90 and 180 days from the beginning of supplementation.

Low-mineral composition without Silymarindietary

Volunteers will receive supplementation for 180 days. They took 4 capsules daily. Two capsules in the morning and two capsules at night. There will be blood and feces collection at zero time, before supplementation, after 30, 90 and 180 days from the beginning of supplementation.