Effect of Genistein in Women With Metabolic Syndrome

NCT00541710 | Completed Phase 2

• 2 other identifiers: RODA-1225420073XZSR3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine whether the phytoestrogen genistein is effective in improving bone condition in pre-menopausal and post-menopausal women suffering for osteopenia. Since, during the study the investigators realized that at least 70% of post-menopausal recruited women suffered for metabolic syndrome (MS), we have added only in these women, as secondary outcome measures, the evaluation of markers of cardiovascular risk.

Conditions

Metabolic Syndrome

Keywords

menopause; genistein; pre-diabetes

Outcome Measures

Primary Outcomes (2)

• markers of bone reabsorption: CTX (C-telopeptide of type I collagen ) and of bone formation: bone ALP (Alkaline phosphatase), plus calcaneus ultrasonography variation values

  baseline and six months for markers of bone reabsorption, while baseline and 12 months for evaluation of calcaneus ultrasonography variation values

• 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

  baseline, 6 months 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: genistein

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: placebo

Interventions

genistein DIETARY_SUPPLEMENT

pills of 27 mg, twice per day for 12 months

Lifestyle counseling

placebo DIETARY_SUPPLEMENT

sugar pills twice per day for 12 months

Genistein

Eligibility Criteria

• Age: 45 Years - 70 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 Palermo

Palermo, Italy, 90129, Italy

Location

Azienda Policlinico Universitario, G. Martino

Messina, 090, Italy

Location

Related Publications (5)

• Marini H, Minutoli L, Polito F, Bitto A, Altavilla D, Atteritano M, Gaudio A, Mazzaferro S, Frisina A, Frisina N, Lubrano C, Bonaiuto M, D'Anna R, Cannata ML, Corrado F, Adamo EB, Wilson S, Squadrito F. Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):839-47. doi: 10.7326/0003-4819-146-12-200706190-00005.

  PMID: 17577003 BACKGROUND

• D'Anna R, Cannata ML, Atteritano M, Cancellieri F, Corrado F, Baviera G, Triolo O, Antico F, Gaudio A, Frisina N, Bitto A, Polito F, Minutoli L, Altavilla D, Marini H, Squadrito F. Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 1-year randomized, double-blind, placebo-controlled study. Menopause. 2007 Jul-Aug;14(4):648-55. doi: 10.1097/01.gme.0000248708.60698.98.

  PMID: 17251874 BACKGROUND

• Crisafulli A, Altavilla D, Squadrito G, Romeo A, Adamo EB, Marini R, Inferrera MA, Marini H, Bitto A, D'Anna R, Corrado F, Bartolone S, Frisina N, Squadrito F. Effects of the phytoestrogen genistein on the circulating soluble receptor activator of nuclear factor kappaB ligand-osteoprotegerin system in early postmenopausal women. J Clin Endocrinol Metab. 2004 Jan;89(1):188-92. doi: 10.1210/jc.2003-030891.

  PMID: 14715848 BACKGROUND

• Morabito N, Crisafulli A, Vergara C, Gaudio A, Lasco A, Frisina N, D'Anna R, Corrado F, Pizzoleo MA, Cincotta M, Altavilla D, Ientile R, Squadrito F. Effects of genistein and hormone-replacement therapy on bone loss in early postmenopausal women: a randomized double-blind placebo-controlled study. J Bone Miner Res. 2002 Oct;17(10):1904-12. doi: 10.1359/jbmr.2002.17.10.1904.

  PMID: 12369794 BACKGROUND

• Irace C, Marini H, Bitto A, Altavilla D, Polito F, Adamo EB, Arcoraci V, Minutoli L, Di Benedetto A, Di Vieste G, de Gregorio C, Gnasso A, Corrao S, Licata G, Squadrito F. Genistein and endothelial function in postmenopausal women with metabolic syndrome. Eur J Clin Invest. 2013 Oct;43(10):1025-31. doi: 10.1111/eci.12139. Epub 2013 Jul 30.

  PMID: 23899172 DERIVED

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

• Rosario D'Anna, professor

  University of Messina, Italy

  PRINCIPAL INVESTIGATOR

• 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: Associate Professor

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 10, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 14, 2012

Record last verified: 2012-09

Locations

IT (3)