Overweight, Obesity
Conditions
Keywords
weight loss, sulphate-bicarbonate-calcium water, gut microbiota, body composition, bile salts
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.
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.
Interventions
DIETARY_SUPPLEMENTAcqua 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.
DIETARY_SUPPLEMENTTap 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.
Sponsors
TERME DI CHIANCIANO Spa, Italy
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight loss | 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
| Measure | Time frame | Description |
|---|---|---|
| gut microbiota composition | 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. |
| body composition | 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. |
| bile acids pool | 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. |
| energy expenditure | 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 |
| thyroid function | 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 |
Countries
Italy
Outcome results
None listed