Effects of Genistein in Postmenopausal Women With Metabolic Syndrome
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|ClinicalTrials.gov Identifier: NCT01664650|
Recruitment Status : Completed
First Posted : August 14, 2012
Last Update Posted : August 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Dietary Supplement: Genistein Dietary Supplement: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Role of Genistein on Metabolic Syndrome in Post-menopausal Women|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||January 2011|
Placebo Comparator: 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.
Dietary Supplement: Placebo
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
- homeostasis model assessment for insulin resistance (HOMA-IR) [ Time Frame: change from baseline at 6 and 12 months ]HOMA-IR was calculated using the following formula: fasting glucose (mg/dl) X fasting insulin (uIU/ml)/22.5.
- body mass index [ Time Frame: basal, 6 and 12 months ]The body mass index (BMI) is calculated by dividing the weight measured in kilograms by the square of the height measured in metres [i.e. BMI = Weight (kg)/ Height (m)]2.
- Blood pressure [ Time Frame: basal, 6 and 12 months ]Three seated blood pressure measurements were taken on the right arm with a sphygmomanometer after the participant had been resting for at least 5 min. Blood pressure values were based on the average of the second and third measurements.
- Metabolic variables [ Time Frame: basal, 6 and 12 months ]Fasting glucose and insulin were measured in serum collected after an overnight fast using routine methods. Total cholesterol, High Density Lipoprotein-Cholesterol (HDL-C), and triglycerides were measured by using a routine enzymatic method, and the Low-Density Lipoprotein Cholesterol (LDL-C) level was calculated by using the Friedewald formula: [Total cholesterol (mg/dL) - High Density Lipoprotein-Cholesterol (HDL-C) (mg/dL) - triglycerides (mg/dL)/5].
- Inflammatory markers [ Time Frame: basal, 6 and 12 months ]Serum visfatin, adiponectin, and homocysteine were measured by using an immunoenzymatic assay was measured by using an immunoenzymatic assay.
- Adverse events [ Time Frame: basal, 6 and 12 months ]Participants were asked about symptoms at clinic visits every 6 months. Standard clinical evaluations and laboratory analyses, including hematologic, renal, and liver function tests, were done every 6 months. Endometrial thickness was evaluated by using ultrasonography at baseline, 6 months, and 1 year. The endometrial thickness was measured in the sagittal plane from 1 basal layer to the other. If the endometrial thickness was 8 mm or greater or if uterine bleeding occurred, hysteroscopy and endometrial biopsy were performed. All unfavorable and unintended clinical effects were considered adverse effects and were evaluated for severity, duration, seriousness, and relation to the study drug and outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664650
|University of Magnia Graecia|
|University of Messina|
|Messina, Italy, 98123|
|University of Palermo|
|Palermo, Italy, 90129|
|Principal Investigator:||Francesco Squadrito, MD||University of Messina|