DRKS00034871尚未招募未知
Effect of a sulfate- and magnesium-rich mineral water on symptoms of functional constipation in healthy adults - a double-blind, randomized, 2-arm, controlled clinical study - SMART-Study (Sulfate- and Magnesium-rich mineral water for Adults to Relief consTipation symptoms)
Gottfried Wilhelm Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung0 个研究点目标入组 206 人开始时间: 2024年8月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 206
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Persons capable of giving consent, diagnosis of functional constipation (Rome IV criteria), BMI 18.5 - <35.0 kg/m², physical active subjects, usual fluid consumption (beverages) at least 1500 mL/day, regulary consumption of fiber (fruits, legumes and/or whole grain)
排除标准
- •Medical and health conditions:
- •Diagnosed medical conditions: chronic diseases of the gastrointestinal tract (e.g. irritable bowel syndrome, ulcerative colitis, Crohn's disease), non-treated thyroid dysfunction, cancer within the last two years, renal conditions (e.g. renal insufficiency, urinary tract diseases), liver disease (e.g. hepatitis, liver cirrhosis, non-alcoholic fatty liver disease)
- •Reproductive status: Pregnant, breastfeeding, or intention to become pregnant during the study
- •Surgery: abdominal surgery within the last 3 months prior to study participation, planned surgeries within the next 3 months
- •Health status: immobile subjects (e.g. bedridden subjects, wheelchair users)
- •Medication and supplements:
- •Medication and supplement alterations: changes to medication or supplement intake that are known to cause constipation (e.g. diuretics, antidepressants, antihypertensive drugs) within the past month prior to study participation and during the intervention study
- •Laxatives: use of laxatives (e.g. bisacodyl-, sodium picosulfate- and makrogol containing drugs) 3 days before run-in
- •Dietary and consumption patterns:
- •Mineral water: consumption of mineral water other than the water provided for the study
- •Dietary modification: planned or suspected modification of dietary habits within stidy period an shortly before
- •Lifestyle factors:
- •Physical activity: planned or suspected modification of physical activity habits within the study period
- •Illicit drug use and medication abuse: current or past-year history
- •Tobacco/nicotine: important changes in nicotine consumption within the past month prior to study participation and during the study period (e.g. stopping nicotine consumption)
- •Legal and regulatory concerns:
- •Study participation: simultaneous participation in another clinical study or within the past 2 months prior to study start
研究者
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