The Effect of Soy Isoflavone Supplementation on Endothelial Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. dr. Pusparini SpPK, Trisakti University
ClinicalTrials.gov Identifier:
NCT01463436
First received: October 25, 2011
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Osteoporosis
Dietary Supplement: soy isoflavone
Dietary Supplement: control group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study of Soy Isoflavone 100 mg/Day in Postmenopausal Women to Elaborate the Effect of Soy Isoflavone in Endothelial Function and to Reduce Oxidative Stress

Resource links provided by NLM:


Further study details as provided by Trisakti University:

Primary Outcome Measures:
  • the changes levels of endothelial function marker in blood after 13 months supplementation [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    this study were measured the change levels of vascular cell adhesion molecule-1 (VCAM-1), nitric oxide (NO) as endothelial function parameter and malonyldialdehide as lipid peroxidation parameter from baseline to 6 months supplementation and from baseline to 13 months supplementation


Secondary Outcome Measures:
  • the changes levels of osteoporosis parameter after 6 months supplementation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    This study have another outcome such as rank ligand, C telopeptide and osteoprotegrin as marker of osteoporosis. We will be measured the changes levels of osteoporosis marker after 6 months supplementation


Enrollment: 200
Study Start Date: January 2010
Study Completion Date: February 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: soy isoflavone 100 mg
the experimental group receiving tablet contain soy isoflavone 100 mg and calcium carbonate 500 mg
Dietary Supplement: soy isoflavone
100 mg soy isoflavone tablet containing genistein 55%, daidzein 39% and glycitein 6% and calcium carbonate 500 mg in the experimental group for 6 months and 12 months
Other Name: kacang kedelai, soya bean
Placebo Comparator: calcium carbonate 500 mg
The control group receiving a tablet contains calcium carbonate 500 mg for 6 months and 12 months
Dietary Supplement: control group
the control group receiving tablet contain calcium carbonate 500 mg/day for 6 months and 12 months
Other Name: plasebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   47 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463436

Locations
Indonesia
Trisakti University
Jakarta, DKI Jakarta, Indonesia
Sponsors and Collaborators
Trisakti University
Investigators
Principal Investigator: Pusparini Sunarno, Doctor Trisakti University
  More Information

Additional Information:
Publications:
Hall WL, Rimbach G, Williams CM. isoflavones and endothelial function. Nutrion Research Review 18:123-131, 2005. Vincent A,Fitzpatrick LA. soy Isoflavone: are they useful in menopause? Mayo clinic Proceeding 75:1171-1184, 2000

Responsible Party: Dr. dr. Pusparini SpPK, Principal investigator, staff of Clinical Pathology Department, Trisakti University
ClinicalTrials.gov Identifier: NCT01463436     History of Changes
Other Study ID Numbers: Usakti
Study First Received: October 25, 2011
Last Updated: November 1, 2011
Health Authority: Indonesia: Departement Kesehatan (Department of Health)

Keywords provided by Trisakti University:
endothelial function
postmenopausal
soy isoflavone supplementation
osteoporosis

Additional relevant MeSH terms:
Cardiovascular Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014