Cardiometabolic Response to a Sodium-bicarbonated Mineral Water

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Dietary supplement: Mineral water

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bicarbonated mineral water (BW); Bicarbonated mineral water	Dietary supplement: Mineral water; Intake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design
Active Comparator: Control mineral water (CW); Mineral water low in mineral content (control)	Dietary supplement: Mineral water; Intake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
LDL-cholesterol	8 weeks
LDL-cholesterol	Baseline
LDL-cholesterol	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Research Council, Spain

Publications and helpful links

General Publications

• 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.

Helpful Links

• full article and supplementary material

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 22, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: BW-13