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

NCT05375487 | Completed

• 1 other identifier: MineralWaterGut
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Discomfort

Outcome Measures

Primary Outcomes (1)

• Difference between the intervention and control group in the change in gastrointestinal transit from baseline to the end of follow-up (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.

  4 weeks

Secondary Outcomes (8)

• 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 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 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 gut microbiota from baseline to the end of follow-up (4 weeks).

  4 weeks

Other Outcomes (1)

• Adverse events

  4 weeks

Study Arms (2)

Carbonated Natural Mineral Water

EXPERIMENTAL

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

Other: Natural Carbonated Mineral Water

Low Mineral Water

PLACEBO COMPARATOR

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

Other: Low Mineral Water

Interventions

Natural Carbonated Mineral Water OTHER

Participants consume 1000 mL per day of natural carbonated mineral water for 4 weeks, divided into four portions: before breakfast, 30 minutes before lunch, during the afternoon, and 30 minutes before dinner. Any additional water intake, if desired, is provided by the study investigators and consists exclusively of low-mineral water in both study arms. Participants record their total weekly water consumption using an electronic form.

Carbonated Natural Mineral Water

Low Mineral Water OTHER

Participants consume 1000 mL per day of low-mineral water for 4 weeks, divided into four portions: before breakfast, 30 minutes before lunch, during the afternoon, and 30 minutes before dinner. Any additional water intake, if desired, is provided by the study investigators and consists exclusively of low-mineral water in both study arms. Participants record their total weekly water consumption using an electronic form.

Low Mineral Water

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• CINTESIS - Center for Health Technology and Services Research: collaborator

Study Sites (1)

NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA

Lisbon, 1169-056, Portugal

Location

Study Officials

• Conceição Calhau, PhD

  NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

  PRINCIPAL INVESTIGATOR

• André Rosário, PhD

  NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

  STUDY DIRECTOR

• Inês Mota

  NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 16, 2022
• Study Start: April 5, 2023
• Primary Completion: October 25, 2023
• Study Completion: November 20, 2023
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)