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临床试验/NCT02867917
NCT02867917已完成不适用

Comparison of Taste and Texture of Metamucil, Volcolon and Psyllium Orange Generic

Amsterdam UMC, location VUmc0 个研究点目标入组 100 人开始时间: 2016年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
主要终点
Taste: 5-point likert scale

研究概览

简要总结

The purpose of this study is to compare 1. taste and 2. texture/palatability of Metamucil orange®, Volcolon® and generic orange psyllium.

详细描述

Background of the study:

A pleasant taste of a prescription improves patient compliance and adherence. According to the literature, only 50% of patients who suffer from chronic diseases adhere to treatment recommendations (1). This results in suboptimal outcomes (2). There are numerous factors that affect adherence, including characteristics of the illness, interaction between physician and patient, the complexity and duration of treatment, side effects of treatment and costs of treatment (3). Furthermore, medication palatability is also crucial for adherence. Several studies have addressed the palatability of medication for different disorders, like hypertension, HIV and Alzheimer's disease (4-6). Therefore, pharmaceutical companies pay attention to manufacture more formulations and add pleasant flavours which may improve the palatability. Fiber supplements are increasingly used for treatment of chronic constipation both in adults and children. In the Netherlands several formulas are available such as Metamucil orange®, Volcolon® en generic psyllium orange. These are effective and save formulas. Little literature is available concerning taste and laxatives or fibers, although many patients complain about taste and texture of the preparations. Studies with polyethylene glycol preparations performed by our research group demonstrated some differences in palatability between these preparations (7-9). There are hardly any studies about fibers and taste. The taste is mentioned to be acceptable; one study compares dried prunes with psyllium and concludes there is no difference in taste experience (10). In order to improve patient compliance, it is of clinical importance to know which preparations are the most acceptable to the patient, and use that as first choice. We hypothese that the taste and palatability of Metamucil orange® is preferable.

Objective of the study:

Comparison of 1. taste and 2. texture/palatability of Metamucil orange®, Volcolon® and generic orange psyllium.

Study design:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteer
  • In good health
  • Able to understand the instruction and give informed consent

排除标准

  • Gastrointestinal problems
  • Swallowing disorders
  • Rheumatic related diseases
  • Known hypersensitivity to the study medication

研究组 & 干预措施

Total group

Other

Volcolon sugar free & Metamucil Orange & Psyllium Orange in a randomized order.

干预措施: Volcolon sugar free (Drug)

Total group

Other

Volcolon sugar free & Metamucil Orange & Psyllium Orange in a randomized order.

干预措施: Metamucil Orange (Drug)

Total group

Other

Volcolon sugar free & Metamucil Orange & Psyllium Orange in a randomized order.

干预措施: Psyllium Orange (Drug)

结局指标

主要结局

Taste: 5-point likert scale

时间窗: Directly after consuming the fiber (1 minute)

1. = very poor taste / unpleasant 2. = poor taste / unpleasant 3. = neutral 4. = tasty / pleasant 5. = very tasty/ very pleasant

Texture: 5-point likert scale

时间窗: Directly after consuming the fiber (1 minute)

1. = very poor taste / unpleasant 2. = poor taste / unpleasant 3. = neutral 4. = tasty / pleasant 5. = very tasty/ very pleasant

次要结局

未报告次要终点

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

PF Vollebregt

MD

Amsterdam UMC, location VUmc

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