The Effect of Natural Carbonated Mineral Water Consumption on Gastrointestinal Transit and Gut Microbiota - A Randomized Controlled Trial

New University of Lisbon

Status: Completed

Conditions: Gastrointestinal Discomfort

Treatments: Other: Low Mineral Water; Other: Natural Carbonated Mineral Water

Study type: Interventional

Funder types: Other

Identifiers

NCT05375487

MineralWaterGut

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Carbonated Natural Mineral Water

Experimental group

Description:

Participants consume 1000 mL per day of natural carbonated mineral water throughout the 4-week study period.

Treatment:

Other: Natural Carbonated Mineral Water

Low Mineral Water

Placebo Comparator group

Description:

Participants consume 1000 mL per day of low-mineral water throughout the 4-week study period.

Treatment:

Other: Low Mineral Water