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

Plain-language summary

This study examines the effects of a nutraceutical (dietary supplement) composition containing natural product derivatives, such as Silymarin, on the body's hormonal and immune systems. It enrolled healthy sedentary volunteers as well as volunteers with overweight or grade 1 obesity. It was a non-phased study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

University of Sao Paulo General Hospital

Intervention

Composition with Silymarin, Low-mineral composition without Silymarin

Start date

5/20/2021

Estimated completion

12/19/2022

Countries

Brazil

Related genes

Locations

• São Paulo, Brazil

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Healthy (healthy) and sedentary volunteers: people without chronic use of drugs for chronic inflammatory diseases that require the use of corticosteroids or NSAIDs (Non-Steroidal Anti-inflammatories) for a period of more than 15 days. BMI (Body Mass Index) of 24.9 Kg / m2.
* Sedentary overweight/obesity grade 1 volunteer: overweight people, with a BMI of 25.0 to 29.9 kg / m2; and grade 1 obesity with a BMI of 30.0 and 34.9 kg / m2, with or without dyslipidemia and/or non-insulin-dependent type 2 diabetics.

Exclusion Criteria:

* Volunteers who are allergic to some of the components of the nutraceutical formulation, who use insulin, corticosteroids, and NSAIDs for more than 15 days, AIDS, hepatitis, patients undergoing chemotherapy.