Clinical trial NCT02154230: Sulphate-bicarbonate-calcium Water, Body Weight and Gut Microbiota
Official title: Effect of Sulphate-bicarbonate-calcium Water Consumption on the Body Weight and Gut Microbiota Composition in Overweight and Obese Patients Under Low-calorie Diet
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Overweight
Obesity
Keywords: weight loss
sulphate-bicarbonate-calcium water
gut microbiota
body composition
bile salts
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: TERME DI CHIANCIANO Spa, Italy
First posted: 2014-06-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Overweight (BMI\>25) and obesity in adults is a global public health concern because weight excess increases the relative risk of disease and mortality 1-4. A range of diseases, notably cardiovascular disease, diabetes and a number of cancers, are related to excess weight 5. Traditional low-calorie diets are frequently ineffective 6. Although a number of pharmacological approaches for treatment of obesity have been investigated, only few are safe and most of them have adverse effects 7,8. Thus, further studies are necessary in order to find natural antiobesity remedies. Gut microbiota composition is thought to influence body weight 9.

As recently demonstrated in our previous study 10, "Acqua Santa di Chianciano"® helps to maintain the body weight and the values of serum lipids stable in subjects under a relatively high-calorie diet. Possible mechanisms may be a) changing the gut microbiota composition and/or b) increasing the concentration and/or the qualitative pattern of serum bile acids with a subsequent increase of the energy expenditure 11. This study wants to assess the effectiveness in losing weight of "Acqua Santa di Chianciano"® in addition to a low-calorie diet and its effects on gut microbiota composition.

Eligibility criteria: 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

Primary outcomes:
measure: weight loss
timeFrame: 12 weeks
Secondary outcomes:
measure: gut microbiota composition
timeFrame: 4 weeks
measure: body composition
timeFrame: 4 weeks
measure: bile acids pool
timeFrame: 4 weeks
measure: energy expenditure
timeFrame: 4 weeks
measure: thyroid function
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Translational and Precision Medicine, Sapienza University of Rome
Study officials:
affiliation: Department of Clinical Medicine, Sapienza University of Rome, Umberto I Hospital
name: Stefano Ginanni Corradini, MD, PhD
role: STUDY_DIRECTOR
affiliation: Wallenberg Laboratory, SU/Sahlgrenska, SE-413 45 Göteborg, Sweden
name: Fredrik Bäckhed, PhD
role: STUDY_DIRECTOR
affiliation: Department of Translational and Precision Medicine, Sapienza University of Rome
name: Alessandro Laviano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Experimental Medicine, Sapienza University of Rome
name: Lorenzo Maria Donini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Translational and Precision Medicine, Sapienza University of Rome
name: Adriano De Santis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Translational and Precision Medicine, Sapienza University of Rome
name: Maurizio Muscaritoli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Translational and Precision Medicine, Sapienza University of Rome
name: Isabella Preziosa, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Greiner T, Backhed F. Effects of the gut microbiota on obesity and glucose homeostasis. Trends Endocrinol Metab. 2011 Apr;22(4):117-23. doi: 10.1016/j.tem.2011.01.002. Epub 2011 Feb 23.
citation: Corradini SG, Ferri F, Mordenti M, Iuliano L, Siciliano M, Burza MA, Sordi B, Caciotti B, Pacini M, Poli E, Santis AD, Roda A, Colliva C, Simoni P, Attili AF. Beneficial effect of sulphate-bicarbonate-calcium water on gallstone risk and weight control. World J Gastroenterol. 2012 Mar 7;18(9):930-7. doi: 10.3748/wjg.v18.i9.930.
citation: Watanabe M, Houten SM, Mataki C, Christoffolete MA, Kim BW, Sato H, Messaddeq N, Harney JW, Ezaki O, Kodama T, Schoonjans K, Bianco AC, Auwerx J. Bile acids induce energy expenditure by promoting intracellular thyroid hormone activation. Nature. 2006 Jan 26;439(7075):484-9. doi: 10.1038/nature04330. Epub 2006 Jan 8.