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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02154230
• Other study ID #: 2488/14.06.2012
• Status: Withdrawn
• Phase: N/A
• Start date: November 2013
• Est. completion date: November 19, 2020

Study information

• Verified date: April 2021
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 19, 2020
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Department of Translational and Precision Medicine, Sapienza University of Rome	Rome

Sponsors (2)

Lead Sponsor	Collaborator
University of Roma La Sapienza	TERME DI CHIANCIANO Spa, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (10)

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. Review. — View Citation

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. — View Citation

Flegal KM, Graubard BI, Williamson DF, Gail MH. Excess deaths associated with underweight, overweight, and obesity. JAMA. 2005 Apr 20;293(15):1861-7. — View Citation

Greiner T, Bäckhed 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. Review. — View Citation

Gronniger JT. A semiparametric analysis of the relationship of body mass index to mortality. Am J Public Health. 2006 Jan;96(1):173-8. Epub 2005 Aug 30. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sjöström 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. Review. — View Citation

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. Epub 2006 Jan 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	gut microbiota composition	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
Secondary	body composition	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
Secondary	bile acids pool	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
Secondary	energy expenditure	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
Secondary	thyroid function	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