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

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.

Conditions

• Overweight
• Obesity

Interventions

DIETARY_SUPPLEMENT

"Acqua Santa di Chianciano"® (sulphate-bicarbonate-calcium water)

During the first 4 weeks the SW-D patients will be asked to drink every morning, before breakfast, within 30 minutes, 500 mL of "Acqua Santa di Chianciano"® at room temperature.

DIETARY_SUPPLEMENT

Tap water

During the first 4 weeks the TW-D patients will be asked to drink every morning, before breakfast, within 30 minutes, 500 mL of tap water at room temperature.

Sponsors & Collaborators

• TERME DI CHIANCIANO Spa, Italy

  collaborator UNKNOWN

• University of Roma La Sapienza

  lead OTHER

Principal Investigators

• Stefano Ginanni Corradini, MD, PhD · Department of Clinical Medicine, Sapienza University of Rome, Umberto I Hospital

• Fredrik Bäckhed, PhD · Wallenberg Laboratory, SU/Sahlgrenska, SE-413 45 Göteborg, Sweden

• Alessandro Laviano, MD, PhD · Department of Translational and Precision Medicine, Sapienza University of Rome

• Lorenzo Maria Donini, MD · Department of Experimental Medicine, Sapienza University of Rome

• Adriano De Santis, MD · Department of Translational and Precision Medicine, Sapienza University of Rome

• Maurizio Muscaritoli, MD · Department of Translational and Precision Medicine, Sapienza University of Rome

• Isabella Preziosa, MD · Department of Translational and Precision Medicine, Sapienza University of Rome

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2014-10-31

Completion

2020-11-19

Countries

• Italy

Study Locations