NCT00301353

Brief Summary

Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing products may be a potential alternative to HRT for preventing bone loss during the menopausal transition. We investigated whether one-year consumption of isoflavone-enriched foods affected bone mineral density, bone metabolism and hormonal status in early postmenopausal women in a randomized double-blind, placebo controlled parallel multi-centre trial.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2002

Geographic Reach
3 countries

3 active sites

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

October 1, 2002

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2006

Completed
Last Updated

May 21, 2015

Status Verified

October 1, 2002

First QC Date

March 3, 2006

Last Update Submit

May 20, 2015

Conditions

Osteoporosis

Keywords

early menopauseisoflavones/phyto-estrogensbone metabolismbone mineral densityhormones

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density of total body and lumbar spine (DXA)

Secondary Outcomes (2)

  • Blood and urine markers for bone formation (ALP, PINP) and bone resorption (DPD, PYD)

  • Hormones (estradiol, FSH, LH, SHBG)

Interventions

Isoflavones-enriched foodsDRUG

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy as assessed by the:
  • health and lifestyle questionnaire
  • physical examination
  • results of the pre-study laboratory tests
  • Caucasian women
  • Postmenopausal (≥12 - ≤60 months since last menses), determined by
  • interview
  • FSH level ≥ 20 IU/l
  • Body Mass Index (BMI) ≥22 - ≤29 kg/m2
  • Voluntary participation
  • Having given their written informed consent
  • Willing to comply with the study procedures
  • Willing to accept use of all nameless data, including publication and the confidential use and storage of all data
  • Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned

You may not qualify if:

  • Participation in any clinical trial including blood sampling and/or administration of products up to 90 days before Day 01 of this study
  • Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of products
  • Osteoporosis, determined by
  • Questionnaire (spontaneous bone fractures, use of medication to treat osteoporosis)
  • Severe scoliosis (curvature of the spine) that could interfere with the ability of the subject to go through the DXA scanning procedure and/or with a correct reading of the DXA scans
  • Having a history of medical or surgical events that may significantly affect the study outcome, including:
  • surgical menopause (including hysterectomy)
  • antecedents and high familiar incidence of breast and/or endometrial cancer
  • gastrointestinal disease (Crohn's, short bowel syndrome, coeliac disease, gastroenteritis episodes the month before the start of the study)
  • hepatic disease (acute or viral hepatitis, chronic hepatitis)
  • cardiovascular disease and thrombosis
  • impaired renal function
  • severe immune disease
  • endocrine diseases (hyperthyroidism, hyperparathyroidism, IDDM, NIDDM)
  • Food allergy as reported by the subject (with special emphasis on soy products) and reported allergy for sunscreen products
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institute National de la Recherche Agronomique

Saint-Genès-Champanelle, 63122, France

Location

National Institute for Research on Food an Nutrition

Rome, 00178, Italy

Location

TNO Quality of Life

Zeist, 3700 AJ, Netherlands

Location

Related Publications (1)

  • Brink E, Coxam V, Robins S, Wahala K, Cassidy A, Branca F; PHYTOS Investigators. Long-term consumption of isoflavone-enriched foods does not affect bone mineral density, bone metabolism, or hormonal status in early postmenopausal women: a randomized, double-blind, placebo controlled study. Am J Clin Nutr. 2008 Mar;87(3):761-70. doi: 10.1093/ajcn/87.3.761.

    PMID: 18326616DERIVED

MeSH Terms

Conditions

OsteoporosisPrimary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Elizabeth Brink, PhD

    TNO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2006

First Posted

March 10, 2006

Study Start

October 1, 2002

Study Completion

July 1, 2004

Last Updated

May 21, 2015

Record last verified: 2002-10

Locations

IT(1)NL(1)FR(1)