NL-OMON49152已完成不适用
Improving constipation by stimulating fiber intake using personalized dietary advice - PAC-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age *18 years and <55 years.
- •- BMI < 30 kg/m2
- •- Has constipation-related complaints. For our study, subjects has to fulfill
- •the following criterion: response <6 to the question *how satisfied are you
- •with your stool pattern*, which is rated on a visual analog scale (VAS) from
- •1-10, together with at least one of the following criteria:
- •1. Habitual stool form of Bristol stool type 1-4 or
- •2. *4 defecations per week
- •Note: these criteria are less stringent than the official *constipation*
- •definition [35], because we preferably want to include participants that do not
- •use laxatives (yet), and we assume that in this *mild constipation* group
- •increasing fiber intake can have the most beneficial effects. Moreover, we
- •chose not to use the Rome IV criteria as definition of constipation-related
- •complaints, due to the proven inability to distinguish functional constipation
- •from Irritable Bowel Syndrome [2]. If there are sufficient eligible
- •participants, the participants with the lowest stool frequency will be selected.
- •- Relatively low fiber intake, for females <26 grams and males <33 grams, as
- •assessed by a fiber screening questionnaire which was validated in the previous
- •study. When enough eligible participants are available, we will choose the
- •participants with the lowest dietary fiber intake.
- •- Living in the surroundings of Wageningen (max. 50 km). Subjects have to visit
- •the research facilities of Human Nutrition a few times for weighing and to
- •drop-off of fecal samples, therefore it is logistically not feasible if
- •subjects life far away. If recruitment is unsuccessful, subjects who live
- •further away will be included and samples will then be collected by researchers
- •or by a parcel service.
- •- In possession of computer (with Chrome browser available) for the PDA, and a
- •mobile phone with android *4.4 or iOS system *9 to use apps. In general, phones
- •which are bought *2013 are compatible with the apps. And independently able to
- •install applications on a phone and log-in on to a website, with the use of a
- •manual and video provided by the researchers.
- •- Signed informed consent.
排除标准
- •- Subjects with a disease that may interfere with the personal dietary advice
- •or outcomes, such as a known autonomic disorder, inflammatory bowel disease,
- •coeliac disease, cancer, dialysis patients, chronic kidney failure, depression
- •or hypothyroidism.
- •- Currently following strict diet and unwilling or unable to change; for
- •example a gluten free diet or a *crash diet* using meal substitutes.
- •- Use of medication that can interfere with the study outcomes, including
- •diuretics, antidepressants, codeine, antibiotics or fiber supplements.
- •Preferably laxative use is excluded, but if recruitment is hurdled by this, we
- •at least exclude specific laxatives like resolor, relistor and constella. These
- •are laxatives who have a significant impact on bowel movements, and are only
- •available on prescription. Osmotic (over the counter available) laxatives will
- •be included if recruitment is difficult. Subjects will then be asked to keep
- •their laxative use stable or reduce, but not to increase usage from their
- •habitual pattern (unless necessary, but then report it to the researchers).
- •Moreover, additional questions regarding laxative usage will be included to
- •estimate the effect of laxatives on stool pattern.
- •- Female subjects: currently pregnant or breastfeeding, or intending to become
- •pregnant during the study, as this can affect stool patterns and wellbeing.
- •- Are simultaneously participating in another study.
- •- Unwilling or unable to fulfil the study criteria.
研究者
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