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Cardiometabolic Response to a Sodium-bicarbonated Mineral Water

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02480816
Enrollment
72
Registered
2015-06-25
Start date
2015-05-01
Completion date
2016-02-01
Last updated
2018-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

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.

Interventions

DIETARY_SUPPLEMENTMineral water

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

Sponsors

National Research Council, Spain
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
LDL-cholesterolBaseline

Secondary

MeasureTime frame
Oxidized LDLBaseline
Serum aldosteroneBaseline
BMIBaseline
Dietary energy intakeBaseline
Dietary protein intakeBaseline
Dietary fat intakeBaseline
Dietary cholesterol intakeBaseline
Dietary carbohydrate intakeBaseline
Urine potassiumBaseline
Urine sodiumBaseline
Diastolic Blood PressureBaseline
Systolic Blood PressureBaseline
Total-cholesterolBaseline
TriglyceridesBaseline
HDL-cholesterolBaseline
Apolipoprotein ABaseline
Apolipoprotein BBaseline
GlucoseBaseline
InsulinBaseline
Urine creatininBaseline
Urine calciumBaseline
Urine pHBaseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026