Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women

Osteoporosis Clinical Trial

Official title:

Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301353
• Other study ID #: Phytos QLRT-2000-00431-WP3
• Status: Completed
• Phase: N/A
• First received: March 3, 2006
• Last updated: May 20, 2015
• Start date: October 2002
• Est. completion date: July 2004

Study information

• Verified date: October 2002
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Healthy as assessed by the:

• health and lifestyle questionnaire

• physical examination

• results of the pre-study laboratory tests

2. Caucasian women

3. Postmenopausal (=12 - =60 months since last menses), determined by

• interview

• FSH level = 20 IU/l

4. Body Mass Index (BMI) =22 - =29 kg/m2

5. Voluntary participation

6. Having given their written informed consent

7. Willing to comply with the study procedures

8. Willing to accept use of all nameless data, including publication and the confidential use and storage of all data

9. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria:

1. Participation in any clinical trial including blood sampling and/or administration of products up to 90 days before Day 01 of this study

2. 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

3. 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

4. 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

5. 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)

6. Food allergy as reported by the subject (with special emphasis on soy products) and reported allergy for sunscreen products

7. 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.

8. Change in smoking habits for the last 2 months

9. Alcohol consumption > 21 units (drinks)/week

10. Reported unexplained weight loss or gain of > 5 % of usual body weight in the month prior to the pre-study screening

11. Reported slimming or medically prescribed diet

12. Professional sportswomen (> 10 hours extensive sports/week)

13. Reported vegan, vegetarian, macrobiotic food intake

14. 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

15. 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

16. Recent blood or plasma donation (<1 month prior to the start of the study)

17. Not willing to stop blood or plasma donation during the study

18. TNO Nutrition and Food Research personnel, their partner and their first and second generation relatives

19. Not having a general practitioner

20. 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

21. Mental status incompatible with the proper conduct of the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Isoflavones-enriched foods

Locations

Country	Name	City	State
France	Institute National de la Recherche Agronomique	Saint-Genes Champanelle
Italy	National Institute for Research on Food an Nutrition	Rome
Netherlands	TNO Quality of Life	Zeist

Sponsors (4)

Lead Sponsor	Collaborator
TNO	European Commission, Institut National de la Recherche Agronomique, National Institute for Research on Food and Nutrition

Countries where clinical trial is conducted

France,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density of total body and lumbar spine (DXA)
Secondary	Blood and urine markers for bone formation (ALP, PINP) and bone resorption (DPD, PYD)
Secondary	Hormones (estradiol, FSH, LH, SHBG)