The Effect of Natural Carbonated Mineral Water Consumption on Gastrointestinal Transit and Gut Microbiota - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference between the intervention and control group in the change in gastrointestinal transit from baseline to the end of follow-up (4 weeks).
研究概览
简要总结
Gastrointestinal discomfort is a common condition associated with aging, low levels of physical activity, and reduced intake of fibre, water, and magnesium. Several studies have reported a positive association between the consumption of hyper-mineral water containing high levels of bicarbonate, calcium, or magnesium and improvements in gastrointestinal transit. There is evidence that magnesium and sulphate, individually, exert a laxative effect; however, the impact of other minerals remains limited.
Different mechanisms have been described to explain how the gut microbiota influences gastrointestinal transit. It is important to understand the characteristics of the gut microbiota and to determine whether the intake of hyper-mineral water, a natural source of minerals, can positively modulate it.
The aim of this randomized, placebo-controlled trial is to evaluate the effects of carbonated mineral water consumption on gastrointestinal transit and gut microbiota composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Age between 18 and 70 years
- •History of gastrointestinal discomfort
- •Not using any laxative drug for 3 days before the screening visit
- •Drinking 1.0 ± 0.5 L of water per day
- •Accepting and signing the informed consent
排除标准
- •Treatment or disease (current or past) likely to interfere with evaluation of the study parameters
- •Taking antibiotics in the 3 months preceding the recruitment visit
- •Taking supplements or any food enriched with or containing bacteria or yeasts likely to have an effect on the gastrointestinal tract, particularly on intestinal transit, digestive comfort, gas production, or the occurrence of abdominal pain, in the 30 days preceding the recruitment visit (these products will also be banned during the study period)
- •Subject having an alcohol consumption of more than 3 glasses of wine per day, or 2 glasses of beer per day, or 1 glass of hard liquor per day
- •Subject having a coffee consumption greater than 5 cups per day
- •Subject with constipation attributable to an organic or anatomical cause (Hirschsprung's disease, hypothyroidism, mental deficiency, psychiatric illness, neurological abnormalities, history of operation of the colon or anus, colorectal cancer, anemia, etc.)
- •Subject with a history of current gastrointestinal pathology or disorder such as duodenal ulcer, chronic colitis, or chronic inflammatory disease of the gastrointestinal tract (Crohn's disease, ulcerative colitis), celiac disease, or irritable bowel syndrome
- •Subject having a history of operation of the digestive tract
- •Subject having undergone surgery in the two months preceding the recruitment visit
- •Subject having undergone bariatric surgery
- •Having participated in a weight loss program (with a 5-10% weight loss) in the last 3 months prior to the recruitment visit
- •Body mass index > 35 kg/m²
- •Taking supplements of magnesium, vitamins, or other minerals during the study period
- •Intake of other carbonated mineral waters beyond the provided water during the study period
- •Pregnancy
- •Participation in another clinical trial during the last 30 days prior to the recruitment visit
研究组 & 干预措施
Carbonated Natural Mineral Water
Participants consume 1000 mL per day of natural carbonated mineral water throughout the 4-week study period.
干预措施: Natural Carbonated Mineral Water (Other)
Low Mineral Water
Participants consume 1000 mL per day of low-mineral water throughout the 4-week study period.
干预措施: Low Mineral Water (Other)
结局指标
主要结局
Difference between the intervention and control group in the change in gastrointestinal transit from baseline to the end of follow-up (4 weeks).
时间窗: 4 weeks
Change in gastrointestinal transit measured by the percentage of responder subjects defined as a composite score of the two following Rome IV criteria: number of stools ≥ 4 or an increase of 2 stools/week and stools consistency with less than 25% of lumpy to hard stools.
次要结局
- Difference between the intervention and control group in the change in gut microbiota from baseline to the end of follow-up (4 weeks).(4 weeks)
- Difference between the intervention and control group in the change in short-chain fatty acid profiling from baseline to the end of follow-up (4 weeks).(4 weeks)
- Difference between the intervention and control group in the change in constipation Quality of Life from baseline to the end of follow-up (4 weeks).(4 weeks)
- Difference between the intervention and control group in the change in stool consistency from baseline to the end of follow-up (4 weeks).(4 weeks)
- Difference between the intervention and control group in the change in constipation symptoms from baseline to the end of follow-up (4 weeks).(4 weeks)
- Difference between the intervention and control group in the change in Perceived Stress Scale from baseline to the end of follow-up (4 weeks).(4 weeks)
- Difference between the intervention and control group in the change in urinary excretion of minerals from baseline to the end of follow-up (4 weeks).(4 weeks)
- Difference between the intervention and control group in the change in urinary pH from baseline to the end of follow-up (4 weeks).(4 weeks)