NCT01293045已完成1 期
Study of Change in Biological Markers of Bone Metabolism Following Consumption of Hydrolyzed Collagen for 3 Months in Healthy, Non-osteoporotic, Menopausal Women.
Nealth Sarl2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2010年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Serum C-terminal telopeptide of type 1 collagen (CTX)
研究概览
简要总结
- Preliminary scientific studies, in both animals and humans suggest that oral consumption of hydrolyzed collagen acts on the bone remodeling process by stimulating the activity of osteoblasts responsible for bone formation while improving the bone mineral density and biomechanical resistance of long bones.
- The objective of this clinical research is to measure changes in biomarkers of bone turnover in postmenopausal healthy women, not osteoporotic, in response to consumption of hydrolyzed collagen for three months.
- For this, we propose to measure blood and urinary markers of formation and bone resorption before consumption, then 45 and 90 days after daily consumption of 10 g of hydrolyzed collagen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women
- •Aged between 55 and 65 years
- •Primary or secondary amenorrhea for at least 5 years
- •BMI ≥ 20 kg/m2 and < 27 kg/m2
- •DXA > 2.5 SD
- •No history of fragility fracture bone
- •Not under guardianship
- •Not on hormone replacement or any osteoporotic therapy
- •Covered by Social Security
- •Negative serology for hepatitis B/C and HIV
- •Written informed consent form signed.
排除标准
- •Bone density < 2.5 SD (standard deviation)
- •Endocrine disease
- •No history of fragility fracture bone
- •Dietary disorder (anorexia, bulimia)
- •Hormone replacement therapy
- •Inclusion in another clinical study
- •Subjects receiving over 4,500 Euros in the last 12 months (including the present study)
- •Subjects presenting risk of non-compliance in the opinion of the recruiting doctor.
结局指标
主要结局
Serum C-terminal telopeptide of type 1 collagen (CTX)
时间窗: Day 45
MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in serum CTX at 45 days
次要结局
- Urinary telopeptide N-terminal of type 1 collagen (NTX)(Day 90)
- Serum osteocalcin(Day 90)
- Serum bone alkaline phosphatase(Day 90)
- Serum amino-terminal pro-peptide of type 1 procollagen (P1NP)(Day 90)
- Serum C-terminal telopeptide of type 1 collagen (CTX)(Day 90)
研究者
研究点 (2)
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