Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02154230
Recruitment Status : Withdrawn (failure to enroll)
First Posted : June 3, 2014
Last Update Posted : May 5, 2021
Sponsor:
Collaborator:
TERME DI CHIANCIANO Spa, Italy
Information provided by (Responsible Party):
STEFANO GINANNI CORRADINI, University of Roma La Sapienza

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Dietary Supplement: "Acqua Santa di Chianciano"® (sulphate-bicarbonate-calcium water) Dietary Supplement: Tap water Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 19, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154230


Locations
Layout table for location information
Italy
Department of Translational and Precision Medicine, Sapienza University of Rome
Rome, Italy, 00185
Sponsors and Collaborators
University of Roma La Sapienza
TERME DI CHIANCIANO Spa, Italy
Investigators
Layout table for investigator information
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:

Layout table for additonal information
Responsible Party: STEFANO GINANNI CORRADINI, MD, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02154230    
Other Study ID Numbers: 2488/14.06.2012
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: April 2021
Keywords provided by STEFANO GINANNI CORRADINI, University of Roma La Sapienza:
weight loss
sulphate-bicarbonate-calcium water
gut microbiota
body composition
bile salts
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs