Effect of a sulfate- and magnesium-rich mineral water on symptoms of functional constipation in healthy adults - a double-blind, randomized, 2-arm, controlled clinical study

Not Applicable

• Conditions: Functional constipation; K59.0; Constipation

• Registration Number: DRKS00034871
• Lead Sponsor: Gottfried Wilhelm Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Persons capable of giving consent, diagnosis of functional constipation (Rome IV criteria), BMI 18.5 - <35.0 kg/m², physical active subjects, usual fluid consumption (beverages) at least 1500 mL/day, regulary consumption of fiber (fruits, legumes and/or whole grain)

Exclusion Criteria

Medical and health conditions:
•Diagnosed medical conditions: chronic diseases of the gastrointestinal tract (e.g. irritable bowel syndrome, ulcerative colitis, Crohn's disease), non-treated thyroid dysfunction, cancer within the last two years, renal conditions (e.g. renal insufficiency, urinary tract diseases), liver disease (e.g. hepatitis, liver cirrhosis, non-alcoholic fatty liver disease)
•Reproductive status: Pregnant, breastfeeding, or intention to become pregnant during the study
•Surgery: abdominal surgery within the last 3 months prior to study participation, planned surgeries within the next 3 months
•Health status: immobile subjects (e.g. bedridden subjects, wheelchair users)
Medication and supplements:
•Medication and supplement alterations: changes to medication or supplement intake that are known to cause constipation (e.g. diuretics, antidepressants, antihypertensive drugs) within the past month prior to study participation and during the intervention study
•Laxatives: use of laxatives (e.g. bisacodyl-, sodium picosulfate- and makrogol containing drugs) 3 days before run-in
Dietary and consumption patterns:
•Mineral water: consumption of mineral water other than the water provided for the study
•Dietary modification: planned or suspected modification of dietary habits within stidy period an shortly before
Lifestyle factors:
•Physical activity: planned or suspected modification of physical activity habits within the study period
•Illicit drug use and medication abuse: current or past-year history
•Tobacco/nicotine: important changes in nicotine consumption within the past month prior to study participation and during the study period (e.g. stopping nicotine consumption)
Legal and regulatory concerns:
•Study participation: simultaneous participation in another clinical study or within the past 2 months prior to study start

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of defecation (bowel movements) between baseline and the end of the intervention (week 3)

Secondary Outcome Measures

Name	Time	Method
Weekly: stool consistency at each bowel movement (Bristol stool chart), stool protocol with pain during bowel movement, fluid protocol, use of laxatives, undesirable effects (adverse events)<br><br>Baseline and final survey: severity of constipation symptoms (PAC-SYM), quality of life (PAC-QoL), nutrition (FFQ), physical activity (EHIS-PAQ), Medication and dietary supplements, smoking behavior<br><br>Run-in and last week of intervention: transit time<br><br>Final survey: tolerability, satisfaction, subjective effect (study participants)<br>