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

April 29, 2021 updated by: STEFANO GINANNI CORRADINI, University of Roma La Sapienza

Effect of Sulphate-bicarbonate-calcium Water Consumption on the Body Weight and Gut Microbiota Composition in Overweight and Obese Patients Under Low-calorie Diet

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00185
        • Department of Translational and Precision Medicine, Sapienza University of Rome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sulphate-bicarbonate-calcium water and low-calorie diet (SW-D)
Experimental arm: Those patients assigned to this interventional arm of the study will be asked to follow a low-calorie diet. For the first 12 weeks, the diet will cover only basal metabolism expenditure ± 10%. At the end of this 12 weeks, for the following 12 weeks, patients will follow a maintenance diet which will cover both basal metabolism and physical activity expenditure. Patients will be invited to maintain the same level of physical activity preceding enrollment throughout the entire study period. During the first 4 weeks these 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: "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.
Active Comparator: tap water and low-calorie diet (TW-D)
Active comparator: Those patients assigned to this interventional arm of the study will be asked to follow the same low-calorie diet of the experimental arm. During the first 4 weeks these patients will be asked to drink every morning, before breakfast, within 30 minutes, 500 mL of Rome tap water 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss
Time Frame: 12 weeks
The primary end-point of the present study is to assess the effect on body weight of the association between sulphate-bicarbonate-calcium water consumption and low-calorie diet (SW-D) compared to tap water and the low-calorie diet (TW-D). The expected result is to obtain a 50% greater mean weight loss in the SW-D than in the TW-D group.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gut microbiota composition
Time Frame: 4 weeks
One of the secondary end-points is the evaluation of the effects of the association between low-calorie diet and sulphate-bicarbonate-calcium water consumption on gut microbiota.
4 weeks
body composition
Time Frame: 4 weeks
One of the secondary end-points is the evaluation of the effects of the association between low-calorie diet and sulphate-bicarbonate-calcium water consumption on body composition (lean body mass/fat body mass) assessed by BIA.
4 weeks
bile acids pool
Time Frame: 4 weeks
One of the secondary end-points is the evaluation of the effects of the association between low-calorie diet and sulphate-bicarbonate-calcium water consumption on the bile acids pool.
4 weeks
energy expenditure
Time Frame: 4 weeks
One of the secondary end-points is the evaluation of the effects of the association between low-calorie diet and sulphate-bicarbonate-calcium water consumption on energy expenditure
4 weeks
thyroid function
Time Frame: 4 weeks
One of the secondary end-points is the evaluation of the effects of the association between low-calorie diet and sulphate-bicarbonate-calcium water consumption on thyroid function
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Collaborators

TERME DI CHIANCIANO Spa, Italy

Investigators

  • Study Director: Stefano Ginanni Corradini, MD, PhD, Department of Clinical Medicine, Sapienza University of Rome, Umberto I Hospital
  • Study Director: Fredrik Bäckhed, PhD, Wallenberg Laboratory, SU/Sahlgrenska, SE-413 45 Göteborg, Sweden
  • Principal Investigator: Alessandro Laviano, MD, PhD, Department of Translational and Precision Medicine, Sapienza University of Rome
  • Principal Investigator: Lorenzo Maria Donini, MD, Department of Experimental Medicine, Sapienza University of Rome
  • Principal Investigator: Adriano De Santis, MD, Department of Translational and Precision Medicine, Sapienza University of Rome
  • Principal Investigator: Maurizio Muscaritoli, MD, Department of Translational and Precision Medicine, Sapienza University of Rome
  • Principal Investigator: Isabella Preziosa, MD, Department of Translational and Precision Medicine, Sapienza University of Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

November 19, 2020

Study Registration Dates

First Submitted

May 30, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2488/14.06.2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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