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Effect of genistein supplementation on serum level of homocystein and PAI-1 (Plasminogen Activator Inhibitor-1) in postmenopausal women with type-2 diabetes mellitus.

Effect of genistein supplementation on serum level of homocystein and PAI-1 (Plasminogen Activator Inhibitor-1) in postmenopausal women with type-2 diabetes mellitus.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100408003664N23
Enrollment
60
Registered
2018-10-30
Start date
2018-09-23
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus. Type 2 diabetes mellitus

Interventions

Intervention 1: Intervention group: 54 mg/day genistein supplement in two capsule for 3 month. Intervention 2: Control group: 54 mg/day placebo in two capsule for 3 month.

Sponsors

Nutritional Reseach Center of Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 67 Years

Inclusion criteria

Inclusion criteria: Willingness to participate in the study Postmenopausal women with history of at least one year menopause Type-2 diabetes for at least 6 months using blood glucose lowering drugs (metformin)

Exclusion criteria

Exclusion criteria: Unwillingness to participate in the study Surgery leads to menopause Early menopause (before 40 years) Use of androgen and estrogen and other steroids can affect the estrogen receptor Insulin injections Use of any nutritional supplements (omega-3) or anti-inflammatory and antioxidant supplements in the last 3 months or during the study Liver and kidney failure, cardiovascular disease, breast cancer and thyroid disease Smoking and alcohol Patients taking NSAID, corticosteroids (prednisone, methylprednisolone, and hydrocortisone), antidiuretic thiazide (furosemide and hydrochlorothiazide) and anti psychotics second generation (olanzapine, clozapine)

Design outcomes

Primary

MeasureTime frame
Homocysteine. Timepoint: Before the intervention and 12 weeks after starting. Method of measurement: ELISA.;PAI-1. Timepoint: Before the intervention and 12 weeks after starting. Method of measurement: ELISA.

Secondary

MeasureTime frame
Physical activity. Timepoint: Beginning and end of intervention. Method of measurement: International Assessment of Physical Activity (IPAQ) questionnaire.;Diet. Timepoint: First, middle and end of study. Method of measurement: 3-day food record.

Countries

Iran (Islamic Republic of)

Contacts

Public Contacthassan Braxas

Tabriz University of Medical Sciences

h.nippon@yahoo.com+98 44 4625 1716

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026