Clinical trial NCT02480816: Cardiometabolic Response to a Sodium-bicarbonated Mineral Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemia
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
First posted: 2015-06-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: LDL-cholesterol
timeFrame: Baseline
measure: LDL-cholesterol
timeFrame: 4 weeks
measure: LDL-cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: Total-cholesterol
timeFrame: Baseline
measure: Total-cholesterol
timeFrame: 4 weeks
measure: Total-cholesterol
timeFrame: 8 weeks
measure: Triglycerides
timeFrame: Baseline
measure: Triglycerides
timeFrame: 4 weeks
measure: Triglycerides
timeFrame: 8 weeks
measure: HDL-cholesterol
timeFrame: Baseline
measure: HDL-cholesterol
timeFrame: 4 weeks
measure: HDL-cholesterol
timeFrame: 8 weeks
measure: Apolipoprotein A
timeFrame: Baseline
measure: Apolipoprotein A
timeFrame: 4 weeks
measure: Apolipoprotein A
timeFrame: 8 weeks
measure: Apolipoprotein B
timeFrame: Baseline
measure: Apolipoprotein B
timeFrame: 4 weeks
measure: Apolipoprotein B
timeFrame: 8 weeks
measure: Glucose
timeFrame: Baseline
measure: Glucose
timeFrame: 4 weeks
measure: Glucose
timeFrame: 8 weeks
measure: Insulin
timeFrame: Baseline
measure: Insulin
timeFrame: 4 weeks
measure: Insulin
timeFrame: 8 weeks
measure: Urine creatinin
timeFrame: Baseline
measure: Urine creatinin
timeFrame: 8 weeks
measure: Urine calcium
timeFrame: Baseline
measure: Urine calcium
timeFrame: 8 weeks
measure: Urine potassium
timeFrame: Baseline
measure: Urine potassium
timeFrame: 8 weeks
measure: Urine sodium
timeFrame: Baseline
measure: Urine sodium
timeFrame: 8 weeks
measure: Urine pH
timeFrame: Baseline
measure: Urine pH
timeFrame: 8 weeks
measure: Systolic Blood Pressure
timeFrame: Baseline
measure: Systolic Blood Pressure
timeFrame: 4 weeks
measure: Systolic Blood Pressure
timeFrame: 8 weeks
measure: Diastolic Blood Pressure
timeFrame: Baseline
measure: Diastolic Blood Pressure
timeFrame: 4 weeks
measure: Diastolic Blood Pressure
timeFrame: 8 weeks
measure: Oxidized LDL
timeFrame: Baseline
measure: Oxidized LDL
timeFrame: 4 weeks
measure: Oxidized LDL
timeFrame: 8 weeks
measure: Serum aldosterone
timeFrame: Baseline
measure: Serum aldosterone
timeFrame: 8 weeks
measure: BMI
timeFrame: Baseline
measure: BMI
timeFrame: 4 weeks
measure: BMI
timeFrame: 8 weeks
measure: Dietary energy intake
timeFrame: Baseline
measure: Dietary energy intake
timeFrame: 8 weeks
measure: Dietary protein intake
timeFrame: Baseline
measure: Dietary protein intake
timeFrame: 8 weeks
measure: Dietary fat intake
timeFrame: Baseline
measure: Dietary fat intake
timeFrame: 8 weeks
measure: Dietary cholesterol intake
timeFrame: Baseline
measure: Dietary cholesterol intake
timeFrame: 8 weeks
measure: Dietary carbohydrate intake
timeFrame: Baseline
measure: Dietary carbohydrate intake
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
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.