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Cardiometabolic Response to a Sodium-bicarbonated Mineral Water

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M Pilar Vaquero, National Research Council, Spain
ClinicalTrials.gov Identifier:
NCT02480816
First received: June 22, 2015
Last updated: June 29, 2015
Last verified: June 2015
History of Changes
June 22, 2015
June 29, 2015
March 2014
November 2014   (Final data collection date for primary outcome measure)
  • LDL-cholesterol [ Time Frame: Baseline ]
  • LDL-cholesterol [ Time Frame: 4 weeks ]
  • LDL-cholesterol [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT02480816 on ClinicalTrials.gov Archive Site
  • Total-cholesterol [ Time Frame: Baseline ]
  • Total-cholesterol [ Time Frame: 4 weeks ]
  • Total-cholesterol [ Time Frame: 8 weeks ]
  • Triglycerides [ Time Frame: Baseline ]
  • Triglycerides [ Time Frame: 4 weeks ]
  • Triglycerides [ Time Frame: 8 weeks ]
  • HDL-cholesterol [ Time Frame: Baseline ]
  • HDL-cholesterol [ Time Frame: 4 weeks ]
  • HDL-cholesterol [ Time Frame: 8 weeks ]
  • Apolipoprotein A [ Time Frame: Baseline ]
  • Apolipoprotein A [ Time Frame: 4 weeks ]
  • Apolipoprotein A [ Time Frame: 8 weeks ]
  • Apolipoprotein B [ Time Frame: Baseline ]
  • Apolipoprotein B [ Time Frame: 4 weeks ]
  • Apolipoprotein B [ Time Frame: 8 weeks ]
  • Glucose [ Time Frame: Baseline ]
  • Glucose [ Time Frame: 4 weeks ]
  • Glucose [ Time Frame: 8 weeks ]
  • Insulin [ Time Frame: Baseline ]
  • Insulin [ Time Frame: 4 weeks ]
  • Insulin [ Time Frame: 8 weeks ]
  • Urine creatinin [ Time Frame: Baseline ]
  • Urine creatinin [ Time Frame: 8 weeks ]
  • Urine calcium [ Time Frame: Baseline ]
  • Urine calcium [ Time Frame: 8 weeks ]
  • Urine potassium [ Time Frame: Baseline ]
  • Urine potassium [ Time Frame: 8 weeks ]
  • Urine sodium [ Time Frame: Baseline ]
  • Urine sodium [ Time Frame: 8 weeks ]
  • Urine pH [ Time Frame: Baseline ]
  • Urine pH [ Time Frame: 8 weeks ]
  • Systolic Blood Pressure [ Time Frame: Baseline ]
  • Systolic Blood Pressure [ Time Frame: 4 weeks ]
  • Systolic Blood Pressure [ Time Frame: 8 weeks ]
  • Diastolic Blood Pressure [ Time Frame: Baseline ]
  • Diastolic Blood Pressure [ Time Frame: 4 weeks ]
  • Diastolic Blood Pressure [ Time Frame: 8 weeks ]
  • Oxidized LDL [ Time Frame: Baseline ]
  • Oxidized LDL [ Time Frame: 4 weeks ]
  • Oxidized LDL [ Time Frame: 8 weeks ]
  • Serum aldosterone [ Time Frame: Baseline ]
  • Serum aldosterone [ Time Frame: 8 weeks ]
  • BMI [ Time Frame: Baseline ]
  • BMI [ Time Frame: 4 weeks ]
  • BMI [ Time Frame: 8 weeks ]
  • Dietary energy intake [ Time Frame: Baseline ]
  • Dietary energy intake [ Time Frame: 8 weeks ]
  • Dietary protein intake [ Time Frame: Baseline ]
  • Dietary protein intake [ Time Frame: 8 weeks ]
  • Dietary fat intake [ Time Frame: Baseline ]
  • Dietary fat intake [ Time Frame: 8 weeks ]
  • Dietary cholesterol intake [ Time Frame: Baseline ]
  • Dietary cholesterol intake [ Time Frame: 8 weeks ]
  • Dietary carbohydrate intake [ Time Frame: Baseline ]
  • Dietary carbohydrate intake [ Time Frame: 8 weeks ]
  • Total-cholesterol [ Time Frame: Baseline ]
  • Total-cholesterol [ Time Frame: 4 weeks ]
  • Total-cholesterol [ Time Frame: 8 weeks ]
  • Triglycerides [ Time Frame: Baseline ]
  • Triglycerides [ Time Frame: 4 weeks ]
  • Triglycerides [ Time Frame: 8 weeks ]
  • HDL-cholesterol [ Time Frame: Baseline ]
  • HDL-cholesterol [ Time Frame: 4 weeks ]
  • HDL-cholesterol [ Time Frame: 8 weeks ]
  • Apolipoprotein A [ Time Frame: Baseline ]
  • Apolipoprotein A [ Time Frame: 4 weeks ]
  • Apolipoprotein A [ Time Frame: 8 weeks ]
  • Apolipoprotein B [ Time Frame: Baseline ]
  • Apolipoprotein B [ Time Frame: 4 weeks ]
  • Apolipoprotein B [ Time Frame: 8 weeks ]
  • Glucose [ Time Frame: Baseline ]
  • Glucose [ Time Frame: 4 weeks ]
  • Glucose [ Time Frame: 8 weeks ]
  • Insulin [ Time Frame: Baseline ]
  • Insulin [ Time Frame: 4 wk ]
  • Insulin [ Time Frame: 8 wk ]
  • Urine creatinin [ Time Frame: Baseline ]
  • Urine creatinin [ Time Frame: 8 wk ]
  • Urine calcium [ Time Frame: Baseline ]
  • Urine calcium [ Time Frame: 8 wk ]
  • Urine potassium [ Time Frame: Baseline ]
  • Urine potassium [ Time Frame: 8 wk ]
  • Urine sodium [ Time Frame: Baseline ]
  • Urine sodium [ Time Frame: 8 wk ]
  • Urine pH [ Time Frame: Baseline ]
  • Urine pH [ Time Frame: 8 wk ]
  • Systolic Blood Pressure [ Time Frame: Baseline ]
  • Systolic Blood Pressure [ Time Frame: 4 wk ]
  • Systolic Blood Pressure [ Time Frame: 8 wk ]
  • Diastolic Blood Pressure [ Time Frame: Baseline ]
  • Diastolic Blood Pressure [ Time Frame: 4 wk ]
  • Diastolic Blood Pressure [ Time Frame: 8 wk ]
  • Oxidized LDL [ Time Frame: Baseline ]
  • Oxidized LDL [ Time Frame: 4 wk ]
  • Oxidized LDL [ Time Frame: 8 wk ]
  • Serum aldosterone [ Time Frame: Baseline ]
  • Serum aldosterone [ Time Frame: 8 wk ]
  • BMI [ Time Frame: Baseline ]
  • BMI [ Time Frame: 4 wk ]
  • BMI [ Time Frame: 8 wk ]
  • Dietary energy intake [ Time Frame: Baseline ]
  • Dietary energy intake [ Time Frame: 8 wk ]
  • Dietary protein intake [ Time Frame: Baseline ]
  • Dietary protein intake [ Time Frame: 8 wk ]
  • Dietary fat intake [ Time Frame: Baseline ]
  • Dietary fat intake [ Time Frame: 8 wk ]
  • Dietary cholesterol intake [ Time Frame: Baseline ]
  • Dietary cholesterol intake [ Time Frame: 8 wk ]
  • Dietary carbohydrate intake [ Time Frame: Baseline ]
  • Dietary carbohydrate intake [ Time Frame: 8 wk ]
Not Provided
Not Provided
 
Cardiometabolic Response to a Sodium-bicarbonated Mineral Water
Not Provided
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Dyslipidemia
Dietary Supplement: Mineral water
Intake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design
  • Experimental: Bicarbonated mineral water (BW)
    Bicarbonated mineral water
    Intervention: Dietary Supplement: Mineral water
  • Active Comparator: Control mineral water (CW)
    Mineral water low in mineral content (control)
    Intervention: Dietary Supplement: Mineral water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
Not Provided
November 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02480816
BW-13
Not Provided
Not Provided
Not Provided
M Pilar Vaquero, National Research Council, Spain
National Research Council, Spain
Not Provided
Not Provided
National Research Council, Spain
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP