Effects of Genistein in Postmenopausal Women With Metabolic Syndrome

NCT ID: NCT01664650

Last Updated: 2012-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-01-31

Brief Summary

The 15-25% of the population of developed countries suffers for metabolic syndrome. It is associated with a 2-4 fold increase in cardiovascular morbility and mortality and with a 5- 9 fold increase in developing type II diabetes. MS prevalence increases after the onset of menopause, because of estrogen deficiency. It is still not clear if menopause itself increases the risk of cardiovascular diseases in al women or only in those that develop MS. Many MS patients that show slight modification in cardiovascular and metabolic parameters are not generally pharmacologically treated since diabetes or alteration in the lipid profile are not evidenced. In this respect it is of importance to develop new therapeutic strategies to prevent and treat MS. Genistein (4,5,7-trihydroxyisoflavone), shown a potentially preventive role on the cardiovascular apparatus in post-menopausal women, may be termed as selective ER modulator (SERM), since it reveals both ER-alpha full agonist and ER-beta partial agonist activity.

Detailed Description

The investigators studied whether genistein may represent an efficacious and safe alternative for reducing vascular risk in postmenopausal women with metabolic syndrome. The clinical study was a randomized, double-blind, placebo-controlled study involving 150 patients with metabolic syndrome. After a 4-week stabilization on a standard fat-reduced diet, participants were randomly assigned to receive either phytoestrogen genistein (54 mg/day) or placebo for 6 months. At baseline and following treatment fasting plasma glucose, insulin, insulin resistance (HOMA-IR), lipid concentrations, plasma total homocysteine, leptin, adiponectin and visfatin were measured. Bioimpedentiometric and nutritional analysis, as well as a safety assessment of the endometrium and vagina were also performed.

Conditions

Metabolic Syndrome

Keywords

menopause; pre-diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lifestyle counseling

Placebo tablets. All participants were counseled on an moderate hypocaloric, Mediterranean-style diet composed of 25% to 30% energy from fat, less than 10% energy from saturated fatty acids, 55% to 60% energy from carbohydrates, and 15% energy from protein, with a cholesterol intake less than 300 mg/d and fiber intake of 35 g/d or greater.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Genistein

Genistein 54 mg/day in 2 tablets for 12 months. All participants were counseled on an moderate hypocaloric, Mediterranean-style diet composed of 25% to 30% energy from fat, less than 10% energy from saturated fatty acids, 55% to 60% energy from carbohydrates, and 15% energy from protein, with a cholesterol intake less than 300 mg/d and fiber intake of 35 g/d or greater.

Group Type: EXPERIMENTAL

Genistein

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Genistein

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Post-menopausal satus
• The presence of three or more of the five following criteria:

1. waist circumference ≥88 cm;

2. Triglycerides ≥150 mg/dl or on drug treatment for elevated triglycerides;

3. high-density-lipoprotein (HDL) cholesterol <50 mg/dl or on drug treatment for reduced HDL-C;

4. Fasting glucose ≥100 mg/dl or on drug treatment for elevated glucose;

5. Blood pressure ≥130/85 mmHg or on antihypertensive drug treatment in a subject with a history of hypertension.

Exclusion Criteria

• clinical or laboratory evidence of confounding systemic diseases (e.g., chronic renal or hepatic failure, chronic inflammatory diseases)
• cardiovascular disease (CVD) defined as documented myocardial infarction, ischaemic heart disease, coronary heart bypass, coronary angioplasty, cerebral thromboembolism, and peripheral amputations, or by Minnesota codes 1°1-3, 4°1-4, 5°1-3 at a standard ECG performed in the 12 months preceding the study;
• coagulopathy;
• use of oral or transdermal estrogen, progestin, androgens, selective estrogen receptor modulators, or other steroids;
• treatment in the preceding six months with polyunsaturated n-3 fatty acids supplements, non steroidal anti-inflammatory drugs (NSAIDs) or steroids, that would interfere with evaluation of the study medication;
• smoking habit of more than 2 cigarettes daily.

• Minimum Eligible Age: 49 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Education, Universities and Research, Italy

OTHER

Sponsor Role: collaborator

University of Messina

OTHER

Sponsor Role: lead

Responsible Party

Francesco Squadrito

Full Professor of Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Squadrito, MD

Role: PRINCIPAL_INVESTIGATOR

University of Messina

Locations

University of Magnia Graecia

Catanzaro, Italy, Italy

University of Messina

Messina, Italy, Italy

University of Palermo

Palermo, Italy, Italy

Countries

Italy

Other Identifiers

20073XZSR3_003

Identifier Type: -

Identifier Source: org_study_id