MedTrace Logo

Nutraceutical Composition Containing Natural Products Derivatives on the Modulation of the Endocrine Neuroimmune Axis

NCT04810572 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2024-02-01

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Composition with Silymarin

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.

DIETARY_SUPPLEMENT

Low-mineral composition without Silymarin

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.

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Ana Flavia M Pessoa, Ph.D · University of São Paulo - Medical School - FMUSP

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2022-05-20
Completion
2022-12-19

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

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 NCT04810572 on ClinicalTrials.gov