The Effect of Soy Isoflavone Supplementation on Endothelial Function

Trisakti University

Status and phase: Completed; Phase 3

Conditions: Osteoporosis; Cardiovascular Disease

Treatments: Dietary Supplement: control group; Dietary Supplement: soy isoflavone

Study type: Interventional

Funder types: Other

Identifiers

NCT01463436

Usakti

Details and patient eligibility

About

A randomized double blind controlled trial was conducted to evaluate the effect of daily supplementation with soy isoflavone 100 mg/day for 12 months on 182 postmenopausal women aged 47 to 60 years at subdistrict South Jakarta Indonesia. The study hypothesis was supplementation soy isoflavone 100 mg/day for 6 and 12 months can increase endothelial function.

Full description

The subject were randomized to the intervention group receiving tablets consisting of 100 mg soy isoflavone and calcium carbonate 500 mg and the control group receiving 500 mg calcium carbonate for 1 year. This study was carried out 13 months(13 x 28 days).

There were three outcome measure from this study; vascular cell adhesion molecule-(VCAM-1), nitric oxide (NO) and malonyldialdehyde (MDA). The outcome measure will be assessed at three times; before soy isoflavone supplementation / the beginning of study,post supplementation 6 months and 12 months. The outcome will be measured change from baseline in the level of VCAM-1, NO and MDA.

Enrollment: 200 patients

Sex: Female

Ages: 47 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy postmenopausal women
• natural cessation 1-10 years
• body mass index <=35 kg/m2
• not receiving medication and supplement in the previous 6 months

Exclusion criteria

• has chronic or terminal disease
• severe psychosis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

soy isoflavone 100 mg

Experimental group

Description:

the experimental group receiving tablet contain soy isoflavone 100 mg and calcium carbonate 500 mg

Treatment:

Dietary Supplement: soy isoflavone

calcium carbonate 500 mg

Placebo Comparator group

Description:

The control group receiving a tablet contains calcium carbonate 500 mg for 6 months and 12 months

Treatment:

Dietary Supplement: control group