Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Serum insulin like growth factor-1 (IGF-I) level
研究概览
简要总结
This multicentre, randomised, double-blind, 2-parallel group, controlled trial aims to investigate whether oral milk protein supplements led to increase in serum Insulin-like Growth Factor-I levels (IGF-I) as compared with a control group fed with an iso-caloric supplement, in women with anorexia nervosa. Subjects receive either 150g/day of tested product or control product for 4-week, followed by a 4-week follow-up.
详细描述
Study centres: 4 active centres in France and 2 active centres in Switzerland
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 18 to 40 years (bounds included).
- •Women with a serum IGF-I level below the 25th percentile of the reference value according to the age (bounds included).
- •Women who had given written inform consent.
- •Women with DSM-IV-confirmed anorexia nervosa lasting for at least 6 months. Women with concomitant binge eating and purging type are also included.
- •Women admitted in-hospital for weight and nutritional rehabilitation. It is anticipated that the patient will stay in-hospital during the full duration of the 4-week supplementation phase, and at least 5 weeks within the study.
- •Women being already regular consumers of dairy products.
- •For women with childbearing potential, use of a contraceptive method.
- •Discontinuation of any mineral and vitamin supplements containing calcium and vitamin D, 1 week before starting the product consumption and during the study.
排除标准
- •Women with primary amenorrhea;
- •Women with lactose intolerance;
- •Women with any other metabolic disease that could affect bone metabolism: osteogenesis imperfecta, Paget's disease of bone, hyperthyroidism, primary hyperparathyroidism;
- •Women with current or past neoplasm;
- •Women with any other severe comorbidity;
- •Pregnant or breast feeding women;
- •Women with epilepsy;
- •Women with any current or past use of the following treatments: bisphosphonates, calcitonin, steroids;
- •Patients enrolled in another clinical study within the last 4 weeks;
- •Patients having already received oral nutritional supplements or who need to receive other oral or intravenous (IV) supplements during the follow-up;
- •Patients having received oral or IV nutritional supplements within two weeks before the inclusion;
- •Patients having willed to participate in another clinical study during the present study phase and 4 weeks after the end of their participation in the present study.
研究组 & 干预措施
Iso-caloric supplement (Control product)
干预措施: Iso-caloric supplement (Control product) (Dietary Supplement)
Oral protein supplement (Tested product)
干预措施: Oral protein supplement (Tested product) (Dietary Supplement)
结局指标
主要结局
Serum insulin like growth factor-1 (IGF-I) level
时间窗: 4-week
The main study product effect criterion is the IGF-I level over the 4-week consumption period.
次要结局
未报告次要终点
研究者
Rene Rizzoli
René Rizzoli, MD (Principal Investigator)
University Hospital, Geneva