Cardiometabolic Response to a Sodium-bicarbonated Mineral Water

Dyslipidemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480816
• Other study ID #: BW-13
• Status: Completed
• Phase: N/A
• Start date: May 1, 2015
• Est. completion date: February 1, 2016

Study information

• Verified date: September 2018
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 1, 2016
• Est. primary completion date: November 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Research Council, Spain

References & Publications (1)

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). pii: E400. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-cholesterol		Baseline
Primary	LDL-cholesterol		4 weeks
Primary	LDL-cholesterol		8 weeks
Secondary	Total-cholesterol		Baseline
Secondary	Total-cholesterol		4 weeks
Secondary	Total-cholesterol		8 weeks
Secondary	Triglycerides		Baseline
Secondary	Triglycerides		4 weeks
Secondary	Triglycerides		8 weeks
Secondary	HDL-cholesterol		Baseline
Secondary	HDL-cholesterol		4 weeks
Secondary	HDL-cholesterol		8 weeks
Secondary	Apolipoprotein A		Baseline
Secondary	Apolipoprotein A		4 weeks
Secondary	Apolipoprotein A		8 weeks
Secondary	Apolipoprotein B		Baseline
Secondary	Apolipoprotein B		4 weeks
Secondary	Apolipoprotein B		8 weeks
Secondary	Glucose		Baseline
Secondary	Glucose		4 weeks
Secondary	Glucose		8 weeks
Secondary	Insulin		Baseline
Secondary	Insulin		4 weeks
Secondary	Insulin		8 weeks
Secondary	Urine creatinin		Baseline
Secondary	Urine creatinin		8 weeks
Secondary	Urine calcium		Baseline
Secondary	Urine calcium		8 weeks
Secondary	Urine potassium		Baseline
Secondary	Urine potassium		8 weeks
Secondary	Urine sodium		Baseline
Secondary	Urine sodium		8 weeks
Secondary	Urine pH		Baseline
Secondary	Urine pH		8 weeks
Secondary	Systolic Blood Pressure		Baseline
Secondary	Systolic Blood Pressure		4 weeks
Secondary	Systolic Blood Pressure		8 weeks
Secondary	Diastolic Blood Pressure		Baseline
Secondary	Diastolic Blood Pressure		4 weeks
Secondary	Diastolic Blood Pressure		8 weeks
Secondary	Oxidized LDL		Baseline
Secondary	Oxidized LDL		4 weeks
Secondary	Oxidized LDL		8 weeks
Secondary	Serum aldosterone		Baseline
Secondary	Serum aldosterone		8 weeks
Secondary	BMI		Baseline
Secondary	BMI		4 weeks
Secondary	BMI		8 weeks
Secondary	Dietary energy intake		Baseline
Secondary	Dietary energy intake		8 weeks
Secondary	Dietary protein intake		Baseline
Secondary	Dietary protein intake		8 weeks
Secondary	Dietary fat intake		Baseline
Secondary	Dietary fat intake		8 weeks
Secondary	Dietary cholesterol intake		Baseline
Secondary	Dietary cholesterol intake		8 weeks
Secondary	Dietary carbohydrate intake		Baseline
Secondary	Dietary carbohydrate intake		8 weeks

External Links

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