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OpenTrials
Completed

NCT Number: NCT02480816

Cardiometabolic Response to a Sodium-bicarbonated Mineral Water

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.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mineral water

Dietary Supplement

Intake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design

Primary outcomes

  1. LDL-cholesterol

    Time frame: Baseline

  2. LDL-cholesterol

    Time frame: 4 weeks

  3. LDL-cholesterol

    Time frame: 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 25, 2015
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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