Cardiometabolic Response to a Sodium-bicarbonated Mineral Water

National Research Council, Spain72 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Dyslipidemia

Interventions

Mineral waterDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

LDL-cholesterol

Time frame: Baseline

LDL-cholesterol

Time frame: 4 weeks

LDL-cholesterol

Time frame: 8 weeks

Secondary Outcomes

Total-cholesterol

Time frame: Baseline

Total-cholesterol

Time frame: 4 weeks

Total-cholesterol

Time frame: 8 weeks

Triglycerides

Time frame: Baseline

Triglycerides

Time frame: 4 weeks

Triglycerides

Time frame: 8 weeks

HDL-cholesterol

Time frame: Baseline

HDL-cholesterol

Time frame: 4 weeks

HDL-cholesterol

Time frame: 8 weeks

Apolipoprotein A

Time frame: Baseline

Apolipoprotein A

Time frame: 4 weeks

Data from ClinicalTrials.gov

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