Cardiometabolic Response to a Sodium-bicarbonated Mineral Water

NCT ID: NCT02480816

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2016-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyslipidemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bicarbonated mineral water (BW)

Bicarbonated mineral water

Group Type EXPERIMENTAL

Mineral water

Intervention Type DIETARY_SUPPLEMENT

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

Control mineral water (CW)

Mineral water low in mineral content (control)

Group Type ACTIVE_COMPARATOR

Mineral water

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mineral water

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Research Council, Spain

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

M Pilar Vaquero

Scientific researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 27367723 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BW-13

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CABALA Diet & Health Study
NCT03369548 UNKNOWN NA