- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00301353
Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women
May 20, 2015 updated by: TNO
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.
Study Overview
Detailed Description
Two hundred and thirty-seven healthy early post-menopausal women (age 53 ± 3 y; time since last menses 33 ± 15 months) consumed isoflavone-enriched foods providing a mean daily intake of 110 mg isoflavone aglycones or control products for 1 yr whilst continuing their habitual diet and lifestyle.
Outcome measures included bone mineral density of lumbar spine and total body, markers for bone formation and bone resorption, hormones, isoflavones in plasma and urine, safety parameters and reporting of adverse events.
Study Type
Interventional
Enrollment
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saint-Genes Champanelle, France, 63122
- Institute National de la Recherche Agronomique
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Rome, Italy, 00178
- National Institute for Research on Food an Nutrition
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Zeist, Netherlands, 3700 AJ
- TNO Quality of Life
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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)
- DXA scans of the lumbar spine between day -14 and day 1 of the study; exclusion threshold is set at -2z score of BMD
- 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
Use of concomitant medication including
- Hormonal replacement therapy (during the study and within the last 6 months before day 01 of the study)
- Current use of corticosteroids (including Aerosol therapy) or past use for more than 10 days within the last 6 months
- Osteoporosis treatment (biphosphonates, SERM's, calcitonin, injectable PTH)
- Other medications known to affect bone metabolism (statins). Use of antibiotics will be carefully recorded.
- Change in smoking habits for the last 2 months
- Alcohol consumption > 21 units (drinks)/week
- Reported unexplained weight loss or gain of > 5 % of usual body weight in the month prior to the pre-study screening
- Reported slimming or medically prescribed diet
- Professional sportswomen (> 10 hours extensive sports/week)
- Reported vegan, vegetarian, macrobiotic food intake
- Regular intake of soy based foods (>2 servings per week). Participation is possible when the subject is prepared to stop consumption from screening until the end of the study
- Taking supplements containing isoflavones, in the 3 months prior to enrolment and during the study. Subjects should not start taking calcium and vitamin D supplements during the study. However, subjects who already take calcium and vitamin D supplements should maintain this intake during the study
- Recent blood or plasma donation (<1 month prior to the start of the study)
- Not willing to stop blood or plasma donation during the study
- TNO Nutrition and Food Research personnel, their partner and their first and second generation relatives
- Not having a general practitioner
- Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health. For example, laboratory results, findings at health and lifestyle questionnaire interview, or physical examination and eventual adverse events communicated to and from their general practitioner
- Mental status incompatible with the proper conduct of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Bone mineral density of total body and lumbar spine (DXA)
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Secondary Outcome Measures
Outcome Measure |
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Blood and urine markers for bone formation (ALP, PINP) and bone resorption (DPD, PYD)
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Hormones (estradiol, FSH, LH, SHBG)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth Brink, PhD, TNO
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Study Completion
July 1, 2004
Study Registration Dates
First Submitted
March 3, 2006
First Submitted That Met QC Criteria
March 8, 2006
First Posted (Estimate)
March 10, 2006
Study Record Updates
Last Update Posted (Estimate)
May 21, 2015
Last Update Submitted That Met QC Criteria
May 20, 2015
Last Verified
October 1, 2002
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Phytos QLRT-2000-00431-WP3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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