NCT00301353已完成不适用
Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women
TNO6 个研究点 分布在 3 个国家目标入组 300 人开始时间: 2002年10月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Bone mineral density of total body and lumbar spine (DXA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Bone mineral density of total body and lumbar spine (DXA)
次要结局
- Blood and urine markers for bone formation (ALP, PINP) and bone resorption (DPD, PYD)
- Hormones (estradiol, FSH, LH, SHBG)
研究者
研究点 (6)
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