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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Isoflavones-enriched foods
Sponsored by
TNO
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring early menopause, isoflavones/phyto-estrogens, bone metabolism, bone mineral density, hormones

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Institute National de la Recherche Agronomique
  • National Institute for Research on Food an Nutrition
  • TNO Quality of Life

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Blood and urine markers for bone formation (ALP, PINP) and bone resorption (DPD, PYD)
Hormones (estradiol, FSH, LH, SHBG)

Full Information

First Posted
March 3, 2006
Last Updated
May 20, 2015
Sponsor
TNO
Collaborators
European Commission, National Institute for Research on Food and Nutrition, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
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1. Study Identification

Unique Protocol Identification Number
NCT00301353
Brief Title
Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women
Official Title
Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2002
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
TNO
Collaborators
European Commission, National Institute for Research on Food and Nutrition, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
early menopause, isoflavones/phyto-estrogens, bone metabolism, bone mineral density, hormones

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Isoflavones-enriched foods
Primary Outcome Measure Information:
Title
Bone mineral density of total body and lumbar spine (DXA)
Secondary Outcome Measure Information:
Title
Blood and urine markers for bone formation (ALP, PINP) and bone resorption (DPD, PYD)
Title
Hormones (estradiol, FSH, LH, SHBG)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Brink, PhD
Organizational Affiliation
TNO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute National de la Recherche Agronomique
City
Saint-Genes Champanelle
ZIP/Postal Code
63122
Country
France
Facility Name
National Institute for Research on Food an Nutrition
City
Rome
ZIP/Postal Code
00178
Country
Italy
Facility Name
TNO Quality of Life
City
Zeist
ZIP/Postal Code
3700 AJ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
18326616
Citation
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.
Results Reference
derived

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

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