Effects of Genistein in Postmenopausal Women With Metabolic Syndrome

NCT01664650 | Completed Phase 2

• 1 other identifier: 20073XZSR3_003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Metabolic Syndrome

Keywords

menopause; pre-diabetes

Outcome Measures

Primary Outcomes (1)

• homeostasis model assessment for insulin resistance (HOMA-IR)

  HOMA-IR was calculated using the following formula: fasting glucose (mg/dl) X fasting insulin (uIU/ml)/22.5.

  change from baseline at 6 and 12 months

Secondary Outcomes (5)

• body mass index

  basal, 6 and 12 months

• Blood pressure

  basal, 6 and 12 months

• Metabolic variables

  basal, 6 and 12 months

• Inflammatory markers

  basal, 6 and 12 months

• Adverse events

  basal, 6 and 12 months

Study Arms (2)

Lifestyle counseling

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Genistein

EXPERIMENTAL

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.

Dietary Supplement: Genistein

Interventions

Genistein DIETARY_SUPPLEMENT

Genistein

Placebo DIETARY_SUPPLEMENT

Lifestyle counseling

Eligibility Criteria

• Age: 49 Years - 67 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal satus
• The presence of three or more of the five following criteria:
• waist circumference ≥88 cm;
• Triglycerides ≥150 mg/dl or on drug treatment for elevated triglycerides;
• high-density-lipoprotein (HDL) cholesterol \<50 mg/dl or on drug treatment for reduced HDL-C;
• Fasting glucose ≥100 mg/dl or on drug treatment for elevated glucose;
• Blood pressure ≥130/85 mmHg or on antihypertensive drug treatment in a subject with a history of hypertension.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Messina: lead
• Ministry of Education, Universities and Research, Italy: collaborator

Study Sites (3)

University of Magnia Graecia

Catanzaro, Italy, Italy

Location

University of Messina

Messina, Italy, 98123, Italy

Location

University of Palermo

Palermo, Italy, 90129, Italy

Location

MeSH Terms

Conditions

Metabolic Syndrome; Glucose Intolerance

Interventions

Genistein

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Francesco Squadrito, MD

  University of Messina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Pharmacology

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 14, 2012
• Study Start: September 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2011
• Last Updated: August 14, 2012

Record last verified: 2012-08

Locations

IT (3)