NCT00545116已完成2 期
Short-term Effects of Hesperidin on Bone Biomarkers in Postmenopausal Women: a Randomized Placebo-controlled Trial
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2007年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers
研究概览
简要总结
The primary objective of this clinical trial is to determine the effects of hesperidin on biochemical markers of bone in post-menopausal women.
The secondary objectives are:
- To investigate changes in bone formation and bone resorption markers in response to hesperidin intake
- To compare the efficacy of hesperidin in a milk versus biscuit
- To collect safety information of hesperidin consumption in a human trial
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Community dwelling women
- •More than 4 years post-menopause (natural or surgical)
- •Generally healthy as determined by standard medical assessment on physical and mental health
- •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
- •Having received both oral and written explanations about the study
- •Having provided her written informed consent
排除标准
- •Intestinal or severe metabolic diseases / disorders such as diabetes, renal, hepatic or pancreatic diseases / disorders, ulcer, hyperthyroidism, malignance, chronic malnutrition
- •Have had major gastrointestinal surgery
- •On therapy with drugs known to interfere with bone metabolism such as steroids, vitamin D or its derivatives, bisphosphonates, strontium ranelate, PTH, calcitonin, raloxifene, etc.
- •Had sustained a fracture in the preceding 12 months
- •On hormone replacement therapy (HRT) in the previous 3 months before entering the study
- •Taking medications containing hesperidin (e.g.Daflon) or known to interfere with hesperidin (statins, therapy for circulatory disorders, anti-depressants)
- •Known to have allergic reactions to citrus-containing foods
- •Baseline calcium intake less than 500 mg/day
- •Have an alcohol intake > 2 glasses of wine per day (3dL/day), or > 2 beers (3dL/d) or > 1 shot glass of hard alcohol
- •Heavy smoker (more than 10 cigs a day)
- •Special dietary habits (vegetarians)
- •Phytoestrogens or antioxidants (dietary supplements) consumption
研究组 & 干预措施
d
Placebo Comparator
Placebo carrier 2: liquid skim milk with the same nutrient composition and appearance as the active milk carrier but minus hesperidin
干预措施: Hesperidin (Other)
c
Placebo Comparator
Placebo carrier 1: biscuit with the same nutrient composition and appearance as the active biscuit carrier but minus hesperidin
干预措施: Hesperidin (Other)
b
Experimental
Active carrier 2: liquid skim milk providing 250 mg hesperidin/serve (200 ml) and containing around 300 mg calcium/serving
干预措施: Hesperidin (Other)
a
Experimental
Active carrier 1: biscuit providing 250 mg hesperidin per piece(6g)
干预措施: Hesperidin (Other)
结局指标
主要结局
Percentage change from baseline for bone formation (serum P1NP & osteocalcin) and bone resorption (urinary NTX & serum CTX) markers
时间窗: Six months
次要结局
- Full blood biochemistry analyses including lipid profile(6 months)
- Percentage change from baseline for osteoarthritis markers (CTX2 and others)(6 months)
研究者
研究点 (1)
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