Vascular Effects of Hesperidin in Metabolic Syndrome

University of Rome Tor Vergata

Status and phase: Unknown; Phase 2

Conditions: Endothelial Dysfunction; Metabolic Syndrome

Treatments: Drug: Placebo; Drug: Hesperidin

Study type: Interventional

Funder types: Other

Identifiers

NCT00914251

073/09

Details and patient eligibility

About

It has been suggested that cardiovascular risk factors either independently or in cluster (metabolic syndrome) increase the risk of both type 2 diabetes (DM2) and cardiovascular diseases (CVD). Consumption of citrus fruits is linked to reduced cardiovascular morbidity and mortality. Hesperidin is a flavanone abundant in citrus fruit with putative vasodilator actions in vitro. While molecular mechanisms of vascular actions of hesperidin begin to be explored, no data on in vivo vascular effect of this flavanone has been ever acquired.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metabolic Syndrome (ATPIII criteria)
• BMI <35
• Age 20-55

Exclusion criteria

• History of cancer.
• History of cardiovascular diseases.
• Any other acute or chronic illness which requires administration of steroids or other drugs able to interfere with glucose or lipid metabolism.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

30 participants in 2 patient groups, including a placebo group

Hesperidin, 500 mg per day

Active Comparator group

Description:

500 mg daily of oral Hesperidin for 3 weeks

Treatment:

Drug: Hesperidin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo