Immune Response Regulation and Nutritional Status of Crohn's Disease Patients Under Anti-TNF-alpha and Azathioprine Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Body mass index
研究概览
简要总结
The objective of this study was to evaluate the effect of Whey Protein (WP) and Soy Protein (SP) nutritional supplements on nutritional status and disease activity in Crohn's disease patients.
详细描述
The patients were split into two groups: one group was supplemented with whey protein and the other, with soy protein. Participants were assessed at three moments: before starting the intervention and after 8 and 16 weeks. The nutritional status and body composition were measured using bioimpedance analysis, anthropometry and albumin and pre-albumin dosages. Dietary intake was determined by 24-h dietary recalls. The disease activity was evaluated by Crohn's Disease Activity Index, serum cytokines and C-reactive protein dosages.
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Crohn's disease patients treated with azathioprine or anti-tumor necrosis factor-alpha (anti-TNF-alpha) or azathioprine and anti-TNF-alpha
排除标准
- •who were using other medication or nutritional supplements.
结局指标
主要结局
Body mass index
时间窗: 16 weeks
Body mass index (BMI) was calculated from weight and height (kilograms per meter squared) and classified according to the World Health Organization.
次要结局
- Body fat percentage(16 weeks)
- Body lean percentage(16 weeks)
- Mid-arm circumference(16 weeks)
- Mid-arm muscle circumference(16 weeks)
- Corrected arm muscle area(16 weeks)
- Crohn's Disease Activity Index(16 weeks)
- C-reactive protein(16 weeks)
- Serum albumin(16 weeks)
- Pre-albumin(16 weeks)
- Triceps skin fold thickness(16 weeks)
研究者
PhD Maria Marluce dos Santos Vilela
MD, PhD
University of Campinas, Brazil