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Cardiometabolic Response to a Sodium-bicarbonated Mineral Water

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mineral water
Sponsored by
National Research Council, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dyslipidemia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Bicarbonated mineral water (BW)

    Control mineral water (CW)

    Arm Description

    Bicarbonated mineral water

    Mineral water low in mineral content (control)

    Outcomes

    Primary Outcome Measures

    LDL-cholesterol
    LDL-cholesterol
    LDL-cholesterol

    Secondary Outcome Measures

    Total-cholesterol
    Total-cholesterol
    Total-cholesterol
    Triglycerides
    Triglycerides
    Triglycerides
    HDL-cholesterol
    HDL-cholesterol
    HDL-cholesterol
    Apolipoprotein A
    Apolipoprotein A
    Apolipoprotein A
    Apolipoprotein B
    Apolipoprotein B
    Apolipoprotein B
    Glucose
    Glucose
    Glucose
    Insulin
    Insulin
    Insulin
    Urine creatinin
    Urine creatinin
    Urine calcium
    Urine calcium
    Urine potassium
    Urine potassium
    Urine sodium
    Urine sodium
    Urine pH
    Urine pH
    Systolic Blood Pressure
    Systolic Blood Pressure
    Systolic Blood Pressure
    Diastolic Blood Pressure
    Diastolic Blood Pressure
    Diastolic Blood Pressure
    Oxidized LDL
    Oxidized LDL
    Oxidized LDL
    Serum aldosterone
    Serum aldosterone
    BMI
    BMI
    BMI
    Dietary energy intake
    Dietary energy intake
    Dietary protein intake
    Dietary protein intake
    Dietary fat intake
    Dietary fat intake
    Dietary cholesterol intake
    Dietary cholesterol intake
    Dietary carbohydrate intake
    Dietary carbohydrate intake

    Full Information

    First Posted
    June 22, 2015
    Last Updated
    September 22, 2018
    Sponsor
    National Research Council, Spain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02480816
    Brief Title
    Cardiometabolic Response to a Sodium-bicarbonated Mineral Water
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2015 (Actual)
    Primary Completion Date
    November 1, 2015 (Actual)
    Study Completion Date
    February 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Research Council, Spain

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bicarbonated mineral water (BW)
    Arm Type
    Experimental
    Arm Description
    Bicarbonated mineral water
    Arm Title
    Control mineral water (CW)
    Arm Type
    Active Comparator
    Arm Description
    Mineral water low in mineral content (control)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Mineral water
    Intervention Description
    Intake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design
    Primary Outcome Measure Information:
    Title
    LDL-cholesterol
    Time Frame
    Baseline
    Title
    LDL-cholesterol
    Time Frame
    4 weeks
    Title
    LDL-cholesterol
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Total-cholesterol
    Time Frame
    Baseline
    Title
    Total-cholesterol
    Time Frame
    4 weeks
    Title
    Total-cholesterol
    Time Frame
    8 weeks
    Title
    Triglycerides
    Time Frame
    Baseline
    Title
    Triglycerides
    Time Frame
    4 weeks
    Title
    Triglycerides
    Time Frame
    8 weeks
    Title
    HDL-cholesterol
    Time Frame
    Baseline
    Title
    HDL-cholesterol
    Time Frame
    4 weeks
    Title
    HDL-cholesterol
    Time Frame
    8 weeks
    Title
    Apolipoprotein A
    Time Frame
    Baseline
    Title
    Apolipoprotein A
    Time Frame
    4 weeks
    Title
    Apolipoprotein A
    Time Frame
    8 weeks
    Title
    Apolipoprotein B
    Time Frame
    Baseline
    Title
    Apolipoprotein B
    Time Frame
    4 weeks
    Title
    Apolipoprotein B
    Time Frame
    8 weeks
    Title
    Glucose
    Time Frame
    Baseline
    Title
    Glucose
    Time Frame
    4 weeks
    Title
    Glucose
    Time Frame
    8 weeks
    Title
    Insulin
    Time Frame
    Baseline
    Title
    Insulin
    Time Frame
    4 weeks
    Title
    Insulin
    Time Frame
    8 weeks
    Title
    Urine creatinin
    Time Frame
    Baseline
    Title
    Urine creatinin
    Time Frame
    8 weeks
    Title
    Urine calcium
    Time Frame
    Baseline
    Title
    Urine calcium
    Time Frame
    8 weeks
    Title
    Urine potassium
    Time Frame
    Baseline
    Title
    Urine potassium
    Time Frame
    8 weeks
    Title
    Urine sodium
    Time Frame
    Baseline
    Title
    Urine sodium
    Time Frame
    8 weeks
    Title
    Urine pH
    Time Frame
    Baseline
    Title
    Urine pH
    Time Frame
    8 weeks
    Title
    Systolic Blood Pressure
    Time Frame
    Baseline
    Title
    Systolic Blood Pressure
    Time Frame
    4 weeks
    Title
    Systolic Blood Pressure
    Time Frame
    8 weeks
    Title
    Diastolic Blood Pressure
    Time Frame
    Baseline
    Title
    Diastolic Blood Pressure
    Time Frame
    4 weeks
    Title
    Diastolic Blood Pressure
    Time Frame
    8 weeks
    Title
    Oxidized LDL
    Time Frame
    Baseline
    Title
    Oxidized LDL
    Time Frame
    4 weeks
    Title
    Oxidized LDL
    Time Frame
    8 weeks
    Title
    Serum aldosterone
    Time Frame
    Baseline
    Title
    Serum aldosterone
    Time Frame
    8 weeks
    Title
    BMI
    Time Frame
    Baseline
    Title
    BMI
    Time Frame
    4 weeks
    Title
    BMI
    Time Frame
    8 weeks
    Title
    Dietary energy intake
    Time Frame
    Baseline
    Title
    Dietary energy intake
    Time Frame
    8 weeks
    Title
    Dietary protein intake
    Time Frame
    Baseline
    Title
    Dietary protein intake
    Time Frame
    8 weeks
    Title
    Dietary fat intake
    Time Frame
    Baseline
    Title
    Dietary fat intake
    Time Frame
    8 weeks
    Title
    Dietary cholesterol intake
    Time Frame
    Baseline
    Title
    Dietary cholesterol intake
    Time Frame
    8 weeks
    Title
    Dietary carbohydrate intake
    Time Frame
    Baseline
    Title
    Dietary carbohydrate intake
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27367723
    Citation
    Toxqui L, Vaquero MP. An Intervention with Mineral Water Decreases Cardiometabolic Risk Biomarkers. A Crossover, Randomised, Controlled Trial with Two Mineral Waters in Moderately Hypercholesterolaemic Adults. Nutrients. 2016 Jun 28;8(7):400. doi: 10.3390/nu8070400.
    Results Reference
    result
    Links:
    URL
    http://www.mdpi.com/2072-6643/8/7/400
    Description
    full article and supplementary material

    Learn more about this trial

    Cardiometabolic Response to a Sodium-bicarbonated Mineral Water

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