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

NCT05375487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-17

No results posted yet for this study

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

Interventions

OTHER

Natural Carbonated Mineral Water

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.

OTHER

Low Mineral Water

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.

Sponsors & Collaborators

  • CINTESIS - Center for Health Technology and Services Research

    collaborator UNKNOWN
  • Universidade Nova de Lisboa

    lead OTHER

Principal Investigators

  • Conceição Calhau, PhD · NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

  • André Rosário, PhD · NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

  • Inês Mota · NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-05
Primary Completion
2023-10-25
Completion
2023-11-20

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05375487 on ClinicalTrials.gov