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Cardiometabolic Response to a Sodium-bicarbonated Mineral Water

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ClinicalTrials.gov Identifier: NCT02480816
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The effects of consuming a sodium-bicarbonated mineral water rich in bicarbonate, sodium, chloride, lithium and silicon are studied in humans. The aim of this assay was to determine whether the consumption of this water as part of the usual diet, reduces cardiometabolic risk factors in adult men and women.

Condition or disease Intervention/treatment
Dyslipidemia Dietary Supplement: Mineral water

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : March 2014
Primary Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Bicarbonated mineral water (BW)
Bicarbonated mineral water
Dietary Supplement: Mineral water
Intake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design
Active Comparator: Control mineral water (CW)
Mineral water low in mineral content (control)
Dietary Supplement: Mineral water
Intake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design


Outcome Measures

Primary Outcome Measures :
  1. LDL-cholesterol [ Time Frame: Baseline ]
  2. LDL-cholesterol [ Time Frame: 4 weeks ]
  3. LDL-cholesterol [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Total-cholesterol [ Time Frame: Baseline ]
  2. Total-cholesterol [ Time Frame: 4 weeks ]
  3. Total-cholesterol [ Time Frame: 8 weeks ]
  4. Triglycerides [ Time Frame: Baseline ]
  5. Triglycerides [ Time Frame: 4 weeks ]
  6. Triglycerides [ Time Frame: 8 weeks ]
  7. HDL-cholesterol [ Time Frame: Baseline ]
  8. HDL-cholesterol [ Time Frame: 4 weeks ]
  9. HDL-cholesterol [ Time Frame: 8 weeks ]
  10. Apolipoprotein A [ Time Frame: Baseline ]
  11. Apolipoprotein A [ Time Frame: 4 weeks ]
  12. Apolipoprotein A [ Time Frame: 8 weeks ]
  13. Apolipoprotein B [ Time Frame: Baseline ]
  14. Apolipoprotein B [ Time Frame: 4 weeks ]
  15. Apolipoprotein B [ Time Frame: 8 weeks ]
  16. Glucose [ Time Frame: Baseline ]
  17. Glucose [ Time Frame: 4 weeks ]
  18. Glucose [ Time Frame: 8 weeks ]
  19. Insulin [ Time Frame: Baseline ]
  20. Insulin [ Time Frame: 4 weeks ]
  21. Insulin [ Time Frame: 8 weeks ]
  22. Urine creatinin [ Time Frame: Baseline ]
  23. Urine creatinin [ Time Frame: 8 weeks ]
  24. Urine calcium [ Time Frame: Baseline ]
  25. Urine calcium [ Time Frame: 8 weeks ]
  26. Urine potassium [ Time Frame: Baseline ]
  27. Urine potassium [ Time Frame: 8 weeks ]
  28. Urine sodium [ Time Frame: Baseline ]
  29. Urine sodium [ Time Frame: 8 weeks ]
  30. Urine pH [ Time Frame: Baseline ]
  31. Urine pH [ Time Frame: 8 weeks ]
  32. Systolic Blood Pressure [ Time Frame: Baseline ]
  33. Systolic Blood Pressure [ Time Frame: 4 weeks ]
  34. Systolic Blood Pressure [ Time Frame: 8 weeks ]
  35. Diastolic Blood Pressure [ Time Frame: Baseline ]
  36. Diastolic Blood Pressure [ Time Frame: 4 weeks ]
  37. Diastolic Blood Pressure [ Time Frame: 8 weeks ]
  38. Oxidized LDL [ Time Frame: Baseline ]
  39. Oxidized LDL [ Time Frame: 4 weeks ]
  40. Oxidized LDL [ Time Frame: 8 weeks ]
  41. Serum aldosterone [ Time Frame: Baseline ]
  42. Serum aldosterone [ Time Frame: 8 weeks ]
  43. BMI [ Time Frame: Baseline ]
  44. BMI [ Time Frame: 4 weeks ]
  45. BMI [ Time Frame: 8 weeks ]
  46. Dietary energy intake [ Time Frame: Baseline ]
  47. Dietary energy intake [ Time Frame: 8 weeks ]
  48. Dietary protein intake [ Time Frame: Baseline ]
  49. Dietary protein intake [ Time Frame: 8 weeks ]
  50. Dietary fat intake [ Time Frame: Baseline ]
  51. Dietary fat intake [ Time Frame: 8 weeks ]
  52. Dietary cholesterol intake [ Time Frame: Baseline ]
  53. Dietary cholesterol intake [ Time Frame: 8 weeks ]
  54. Dietary carbohydrate intake [ Time Frame: Baseline ]
  55. Dietary carbohydrate intake [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults, men and women >18 and ≤ 45 years
  • Total-cholesterol > 200 mg/dL and < 300 mg/dL

Exclusion Criteria:

  • Age <18 and > 45 years
  • Total-cholesterol ≥300 mg/dL
  • Triglycerides > 250 mg/dL
  • Total-cholesterol / HDL-cholesterol > 6
  • Being a usual consumer of carbonic mineral water
  • BMI < 20 and >30 kg/m2
  • Diabetes
  • Hypertension or digestive, liver or renal disease
  • Eating disorders
  • Being under medication that could affect lipid metabolism
  • Consumption of functional foods that could affect lipid metabolism (food containing n-3 fatty acids or phytosterols)
More Information

Responsible Party: M Pilar Vaquero, Scientific researcher, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT02480816     History of Changes
Other Study ID Numbers: BW-13
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases