OsteoporosisNCT00301353
Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women
A study testing Isoflavones-enriched foods in people with Osteoporosis, run by TNO at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Isoflavones-enriched foods
- How many people
- 300 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2002to Jul 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
France1 site
Institute National de la Recherche Agronomique
Saint-Genès-Champanelle, 63122
About this study
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Isoflavones-enriched foods
- Keywords
- early menopause, isoflavones/phyto-estrogens, bone metabolism, bone mineral density, hormones
- Medical subject headings
- Osteoporosis, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoflavones-enriched foodsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startOct 2002
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, National Institute for Research on Food and Nutrition, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Elizabeth Brink, PhD, Principal investigator, TNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301353
- Sponsor's protocol ID
- Phytos QLRT-2000-00431-WP3
- Status last verified
- Oct 2002
- First submitted
- 3 Mar 2006
- Last updated
- 21 May 2015
- Results posted
- No
Publications
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.
PubMed 18326616
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00301353
- Acronym / sponsor ID
- Phytos QLRT-2000-00431-WP3
- Conditions
- Osteoporosis
- Keywords
- early menopause, isoflavones/phyto-estrogens, bone metabolism, bone mineral density, hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- European Commission, National Institute for Research on Food and Nutrition, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- Oct 2002
- Study completion
- Jul 2004
- First posted
- 10 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy as assessed by the:
- Caucasian women
- Postmenopausal (≥12 - ≤60 months since last menses), determined by
- Body Mass Index (BMI) ≥22 - ≤29 kg/m2
- Voluntary participation
Key exclusion criteria (35 listed)
- 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
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isoflavones-enriched foods | Drug | – |
Primary outcome
Bone mineral density of total body and lumbar spine (DXA)
2 secondary outcomes
Blood and urine markers for bone formation (ALP, PINP) and bone resorption (DPD, PYD)
Hormones (estradiol, FSH, LH, SHBG)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- Derived from this study: PubMed 18326616Brink 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Brink, PhD principal investigator
TNO
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoflavones-enriched foods in people with Osteoporosis, run by TNO at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density of total body and lumbar spine (DXA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00301353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.