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Cardiometabolic Response to a Sodium-bicarbonated Mineral Water

Not Applicable
Completed
Conditions
Dyslipidemia
Interventions
Dietary Supplement: Mineral water
Registration Number
NCT02480816
Lead Sponsor
National Research Council, Spain
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
72
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Bicarbonated mineral water (BW)Mineral waterBicarbonated mineral water
Control mineral water (CW)Mineral waterMineral water low in mineral content (control)
Primary Outcome Measures
NameTimeMethod
LDL-cholesterol8 weeks
Secondary Outcome Measures
NameTimeMethod
Apolipoprotein A8 weeks
Total-cholesterol8 weeks
Triglycerides8 weeks
HDL-cholesterol8 weeks
Insulin8 weeks
Urine pH8 weeks
Serum aldosterone8 weeks
BMI8 weeks
Dietary protein intake8 weeks
Dietary fat intake8 weeks
Glucose8 weeks
Oxidized LDL8 weeks
Dietary energy intake8 weeks
Dietary cholesterol intake8 weeks
Apolipoprotein B8 weeks
Urine potassium8 weeks
Urine sodium8 weeks
Systolic Blood Pressure8 weeks
Diastolic Blood Pressure8 weeks
Dietary carbohydrate intake8 weeks
Urine creatinin8 weeks
Urine calcium8 weeks
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