NCT03553381

Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome

Completed Last updated 12 June 2018

What this trial tests

trial testing hypocaloric balanced diet in Metabolic Syndrome in 80 participants. Completed in 30 April 2018.

Timeline

30 December 2010

Primary endpoint
30 April 2012

30 April 2018

Quick facts

Lead sponsor	roberta cazzola
Status	Completed
Study type	OBSERVATIONAL
Enrollment	80
Start date	30 December 2010
Primary completion	30 April 2012
Estimated completion	30 April 2018
Sites	2 locations across Italy

Drugs / interventions tested

• hypocaloric balanced diet

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →
• Obesity, Metabolically Benign — all drugs for Obesity, Metabolically Benign →

Sponsor

roberta cazzola

Who can join

Adults 18 to 55, any sex, with Metabolic Syndrome or Obesity, Metabolically Benign. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Obesity is associated with general low grade inflammation and, consequently, of oxidative stress that affects properties and functionality of lipoproteins. Metabolic syndrome exacerbate low grade inflammation. The intentional weight loss of at least 5% of the initial weight can modulate the pro-inflammatory state and reduce the oxidative stress related to the metabolic syndrome, thus diminishing the cardiovascular risk.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Anti-inflammatory effects of diet and caloric restriction in metabolic syndrome.
   Montefusco L, D'Addio F, Loretelli C, Ben Nasr M, et al · · 2021 · cited 51× · PMID 33686615 · DOI 10.1007/s40618-021-01547-y