Sulphate-bicarbonate-calcium Water, Body Weight and Gut Microbiota
NCT ID: NCT02154230
Last Updated: 2021-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2013-11-30
2020-11-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Non-nutritive Sweeteners on the Composition of the Gut Microbiome
NCT02877186
The Effect of Sugar Sweetened and Diet Beverages Consumed as Part of a Weight-Maintenance Diet on Fat Storage
NCT02252952
The Effects of Beverages on Food Liking
NCT03579043
Low-calorie Sweeteners and Adipose Signaling
NCT03125356
Effects of Low Calorie Sweeteners on Dietary Intakes, Hunger, Appetite and Satiety
NCT02297880
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
"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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
"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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age between 18 and 65 years
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TERME DI CHIANCIANO Spa, Italy
UNKNOWN
University of Roma La Sapienza
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
STEFANO GINANNI CORRADINI
MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stefano Ginanni Corradini, MD, PhD
Role: STUDY_DIRECTOR
Department of Clinical Medicine, Sapienza University of Rome, Umberto I Hospital
Fredrik Bäckhed, PhD
Role: STUDY_DIRECTOR
Wallenberg Laboratory, SU/Sahlgrenska, SE-413 45 Göteborg, Sweden
Alessandro Laviano, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Translational and Precision Medicine, Sapienza University of Rome
Lorenzo Maria Donini, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Experimental Medicine, Sapienza University of Rome
Adriano De Santis, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Translational and Precision Medicine, Sapienza University of Rome
Maurizio Muscaritoli, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Translational and Precision Medicine, Sapienza University of Rome
Isabella Preziosa, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Translational and Precision Medicine, Sapienza University of Rome
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Translational and Precision Medicine, Sapienza University of Rome
Rome, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2488/14.06.2012
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.