Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Ratings of gastrointestinal comfort
研究概览
简要总结
The objective of the Orlifat trial is to investigate if dietary fibres from linseeds and dairy calcium (Capolac ®) may reduce gastrointestinal side effects related to increased fecal fat content, induced by treatment with Alli® (orlistat). Secondly, effect on food intake, anthropometry, Quality of Life and cardiovascular risk markers will be evaluated. The trial is designed as a randomised 2 x 2 factorial 13-weeks parallel intervention, in which 72 obese participants will be randomised to supplementation with flaxseed fibres and/or dairy calcium concentrate (Capolac) in addition to treatment with Alli ®:
- Alli® (60 mg t.i.d) plus placebo (rice flour)
- Alli® plus 5 g flaxseed fibers
- Alli® plus 1200 mg Ca from Capolac
- Alli® plus 5 g flaxseed fibers and 1200 mg Ca from Capolac
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20-60 years of age
- •men and women
- •BMI 30-40 kg/m2
排除标准
- •Dairy allergy and/or intolerance, allergy to Orlistat
- •Infectious and metabolic diseases
- •Gastrointestinal diseases (previous and current)
- •Troubles swallowing tablets and capsules
- •Dietary supplement use during the trial and 1 month prior to the trial
- •Postmenopausal (selfreported)
- •Pregnancy and lactation
- •Treatment with oral anticoagulation medications, ciclosporin, levothyroxin, antiepileptika, acarbose and amiodaron
- •Prescription medication will be considered on an individual basis at the screening visit according to SOP
- •Dieting or other changes of diet within 3 months
- •Participation in other trials
研究组 & 干预措施
Control
Alli treatment plus placebo (rice flour)
干预措施: Control (Dietary Supplement)
Capolac
Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)
干预措施: Capolac (Dietary Supplement)
Flax fiber
Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)
干预措施: Flax fiber (Dietary Supplement)
Capolac+Flax fiber
Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)
干预措施: Capolac+Flax fiber (Dietary Supplement)
结局指标
主要结局
Ratings of gastrointestinal comfort
时间窗: baseline, week 0, 2, 4, 8, 12
Subjective assessment of gastrointestinal comfort using visual analogue scales
次要结局
- Ratings of quality of life(baseline, week 0, 2, 4, 8 and 12)
- Body weight(baseline, week 0, 2, 4, 6, 8, 10 and 12)
- Total fecal fat excretion(week 0 and 4)
- Total, LDL and HDL cholesterol(baseline and 12)
- Waist and hip circumference(Baseline, week 0, 2, 4, 6, 8, 10 and 12)
- food intake(week 0 and 4)
- Habitual intake of dietary fiber and calcium(baseline)
研究者
Arne Astrup
Professer, Dr. Med.
University of Copenhagen