The Effect of Natural Carbonated Mineral Water Consumption on Gastrointestinal Transit and on Gut Microbiota in Subjects With Functional Constipation: A Randomized, Placebo-Controlled Pilot Trial

NCT ID: NCT05375487

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2022-12-31

Brief Summary

Functional constipation (FC) is a common condition associated with aging, lower socioeconomic status, low physical activity and also with reduced fibre, water and magnesium intakes. Different studies have reported a positive association between the intake of hyper-mineral water containing a high content of bicarbonate, calcium, or magnesium, and the improve of the gastrointestinal transit. There is evidence that magnesium and sulphate, both individually, have a laxative action. However, the impact of other minerals is scarce. It has been described different mechanisms explaining how gut microbiota influence the gastrointestinal transit. Specifically, in FC patients, it is important to understand the particularities of their gut microbiota and understand whether the intake of hyper-mineral water, a natural source of minerals, can modify positively the gut microbiota. The aim of the present randomized placebo-controlled pilot trial is to evaluate, for the first time, the effect of the carbonated mineral water consumption in the gastrointestinal transit and in the gut microbiota of subjects with FC.

Conditions

Functional Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Carbonated Natural Mineral Water

750 mL/day of carbonated natural mineral water, with high content of bicarbonate, calcium and magnesium.

Group Type: EXPERIMENTAL

Carbonated Natural Mineral Water

Intervention Type: OTHER

750 mL/day of carbonated natural mineral water, with high content of bicarbonate, calcium, and magnesium, in three portions of 250 mL (one portion 30 minutes prior to lunch, one during the afternoon and the last portion minutes before dinner), during 4 weeks.

Low Mineral Water

750 mL/day of low mineral water.

Group Type: PLACEBO_COMPARATOR

Low Mineral Water

Intervention Type: OTHER

750 mL/day of low mineral water (one third prior to lunch, one third during the afternoon and the last third 30 minutes before dinner), during 4 weeks.

Interventions

Carbonated Natural Mineral Water

750 mL/day of carbonated natural mineral water, with high content of bicarbonate, calcium, and magnesium, in three portions of 250 mL (one portion 30 minutes prior to lunch, one during the afternoon and the last portion minutes before dinner), during 4 weeks.

Intervention Type: OTHER

Low Mineral Water

750 mL/day of low mineral water (one third prior to lunch, one third during the afternoon and the last third 30 minutes before dinner), during 4 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 18 to 70
• Having Functional Constipation diagnosis criteria, according to the Rome IV criteria
• Not using any laxative drug for 3 days before screening visit
• Drinking 1.0 ± 0.5 L of water per day
• Accept and sign the 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 and any food enriched or presented containing bacteria or yeasts likely to have an effect on the gastrointestinal tract, particularly on intestinal transit, digestive comfort, gas production, 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 a day, or 2 glasses of beer a day, or 1 glass of hard liquor a 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 syndrome irritable bowel
• 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
• History of renal disease (renal insufficiency etc.) or cardiovascular disease (cardiac insufficiency...), respiratory disease, neural disease
• 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 given water, during the study period.
• Pregnancy
• Participation in another clinical trial during the last 30 days prior to the recruitment visit

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CINTESIS - Center for Health Technology and Services Research

UNKNOWN

Sponsor Role: collaborator

Universidade Nova de Lisboa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Conceição Calhau, PhD

Role: PRINCIPAL_INVESTIGATOR

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

André Rosário, PhD

Role: STUDY_DIRECTOR

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

Inês Mota

Role: STUDY_DIRECTOR

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

Locations

NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA

Lisbon, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Inês Mota

Role: CONTACT

estudo.agua@nms.unl.pt

+351 218 803 053

André Rosário, PhD

Role: CONTACT

+351 218 803 053

Facility Contacts

Inês Mota

Role: primary

estudo.agua@nms.unl.pt

Other Identifiers

MineralWaterGut

Identifier Type: -

Identifier Source: org_study_id