WithdrawnNot Applicable

Sulphate-bicarbonate-calcium Water, Body Weight and Gut Microbiota

Stopped: failure to enroll

Italy0Started 2013-11

Plain-language summary

Overweight and obese patients will be recruited and randomly assigned to two groups of intervention. To the first group \[sulphate-bicarbonate-calcium water and low-calorie diet (SW-D)\] will be administered "Acqua Santa di Chianciano"®, associated to a personalized low calorie diet, while the second group \[tap water and low-calorie diet (TW-D)\] will follow the personalized low calorie diet but will be asked to drink the same quantity of tap water, over a 4 week period. Stool samples will be collected and analyzed for changes in gut microbiota composition. Patients' body weight will be recorded at the beginning and at the end of the study.

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women with BMI between 29 and 35 kg/m2 * Age between 18 and 65 years Exclusion Criteria: * Therapy with antibiotics, bile salts, cholestyramine, laxatives, pre- or probiotics during the last 3 months before enrollment * Helycobacter Pylori positivity * Previous cholecystectomy * Gallbladder disease * Cholestasis * Consumption of more than 20 g of alcohol/day * Inflammatory bowel diseases * Previous gastrointestinal surgery modifying the anatomy * Pregnancy or lactating state * Prescribed hypocaloric diet in the three previous months

What they're measuring

weight loss

Timeframe: 12 weeks

Trial details

NCT IDNCT02154230

SponsorUniversity of Roma La Sapienza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-10

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