NCT02154230

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2020

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

May 30, 2014

Last Update Submit

April 29, 2021

Conditions

OverweightObesity

Keywords

weight losssulphate-bicarbonate-calcium watergut microbiotabody compositionbile salts

Outcome Measures

Primary Outcomes (1)

  • weight loss

    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 Outcomes (5)

  • gut microbiota composition

    4 weeks

  • body composition

    4 weeks

  • bile acids pool

    4 weeks

  • energy expenditure

    4 weeks

  • thyroid function

    4 weeks

Study Arms (2)

sulphate-bicarbonate-calcium water and low-calorie diet (SW-D)

EXPERIMENTAL

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)

tap water and low-calorie diet (TW-D)

ACTIVE COMPARATOR

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

Interventions

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

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.

sulphate-bicarbonate-calcium water and low-calorie diet (SW-D)
Tap waterDIETARY_SUPPLEMENT

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.

tap water and low-calorie diet (TW-D)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with BMI between 29 and 35 kg/m2
  • Age between 18 and 65 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Translational and Precision Medicine, Sapienza University of Rome

Rome, 00185, Italy

Location

Related Publications (10)

  • Flegal KM, Graubard BI, Williamson DF, Gail MH. Excess deaths associated with underweight, overweight, and obesity. JAMA. 2005 Apr 20;293(15):1861-7. doi: 10.1001/jama.293.15.1861.

    PMID: 15840860BACKGROUND

  • Gronniger JT. A semiparametric analysis of the relationship of body mass index to mortality. Am J Public Health. 2006 Jan;96(1):173-8. doi: 10.2105/AJPH.2004.045823. Epub 2005 Aug 30.

    PMID: 16131644BACKGROUND

  • Peeters A, Barendregt JJ, Willekens F, Mackenbach JP, Al Mamun A, Bonneux L; NEDCOM, the Netherlands Epidemiology and Demography Compression of Morbidity Research Group. Obesity in adulthood and its consequences for life expectancy: a life-table analysis. Ann Intern Med. 2003 Jan 7;138(1):24-32. doi: 10.7326/0003-4819-138-1-200301070-00008.

    PMID: 12513041BACKGROUND

  • Sjostrom L. Review of the key results from the Swedish Obese Subjects (SOS) trial - a prospective controlled intervention study of bariatric surgery. J Intern Med. 2013 Mar;273(3):219-34. doi: 10.1111/joim.12012. Epub 2013 Feb 8.

    PMID: 23163728BACKGROUND

  • Jeffery RW, Kelly KM, Rothman AJ, Sherwood NE, Boutelle KN. The weight loss experience: a descriptive analysis. Ann Behav Med. 2004 Apr;27(2):100-6. doi: 10.1207/s15324796abm2702_4.

    PMID: 15026294BACKGROUND

  • Ryan DH, Bray GA, Helmcke F, Sander G, Volaufova J, Greenway F, Subramaniam P, Glancy DL. Serial echocardiographic and clinical evaluation of valvular regurgitation before, during, and after treatment with fenfluramine or dexfenfluramine and mazindol or phentermine. Obes Res. 1999 Jul;7(4):313-22. doi: 10.1002/j.1550-8528.1999.tb00414.x.

    PMID: 10440587BACKGROUND

  • Carter R, Mouralidarane A, Ray S, Soeda J, Oben J. Recent advancements in drug treatment of obesity. Clin Med (Lond). 2012 Oct;12(5):456-60. doi: 10.7861/clinmedicine.12-5-456.

    PMID: 23101148BACKGROUND

  • 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.

    PMID: 21353592BACKGROUND

  • 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.

    PMID: 22408352BACKGROUND

  • 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.

    PMID: 16400329BACKGROUND

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • 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

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 30, 2014

First Posted

June 3, 2014

Study Start

November 1, 2013

Primary Completion

October 1, 2014

Study Completion

November 19, 2020

Last Updated

May 5, 2021

Record last verified: 2021-04

Locations

IT(1)