NCT01463436

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2011

Completed
Last Updated

November 2, 2011

Status Verified

November 1, 2011

Enrollment Period

2 months

First QC Date

October 25, 2011

Last Update Submit

November 1, 2011

Conditions

Cardiovascular DiseaseOsteoporosis

Keywords

endothelial functionpostmenopausalsoy isoflavone supplementationosteoporosis

Outcome Measures

Primary Outcomes (1)

  • the changes levels of endothelial function marker in blood after 13 months supplementation

    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

    13 months

Secondary Outcomes (1)

  • the changes levels of osteoporosis parameter after 6 months supplementation

    6 months

Study Arms (2)

soy isoflavone 100 mg

EXPERIMENTAL

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

Dietary Supplement: soy isoflavone

calcium carbonate 500 mg

PLACEBO COMPARATOR

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

Dietary Supplement: control group

Interventions

soy isoflavoneDIETARY_SUPPLEMENT

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

Also known as: kacang kedelai, soya bean
soy isoflavone 100 mg
control groupDIETARY_SUPPLEMENT

the control group receiving tablet contain calcium carbonate 500 mg/day for 6 months and 12 months

Also known as: plasebo
calcium carbonate 500 mg

Eligibility Criteria

Age47 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • has chronic or terminal disease
  • severe psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trisakti University

Jakarta, DKI Jakarta, Indonesia

Location

Related Publications (1)

  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesOsteoporosis

Interventions

Soybean ProteinsControl Groups

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and BeveragesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Pusparini Sunarno, Doctor

    Trisakti University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, staff of Clinical Pathology Department

Study Record Dates

First Submitted

October 25, 2011

First Posted

November 1, 2011

Study Start

January 1, 2010

Primary Completion

March 1, 2010

Study Completion

February 1, 2011

Last Updated

November 2, 2011

Record last verified: 2011-11

Locations

ID(1)