Cardiometabolic Response to a Sodium-bicarbonated Mineral Water
1 other identifier
interventional
72
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 22, 2015
CompletedFirst Posted
Study publicly available on registry
June 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedSeptember 25, 2018
September 1, 2018
6 months
June 22, 2015
September 22, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
LDL-cholesterol
Baseline
LDL-cholesterol
4 weeks
LDL-cholesterol
8 weeks
Secondary Outcomes (55)
Total-cholesterol
Baseline
Total-cholesterol
4 weeks
Total-cholesterol
8 weeks
Triglycerides
Baseline
Triglycerides
4 weeks
- +50 more secondary outcomes
Study Arms (2)
Bicarbonated mineral water (BW)
EXPERIMENTALBicarbonated mineral water
Control mineral water (CW)
ACTIVE COMPARATORMineral water low in mineral content (control)
Interventions
Intake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design
Eligibility Criteria
You may qualify if:
- Healthy adults, men and women \>18 and ≤ 45 years
- Total-cholesterol \> 200 mg/dL and \< 300 mg/dL
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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):400. doi: 10.3390/nu8070400.
PMID: 27367723RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Scientific researcher
Study Record Dates
First Submitted
June 22, 2015
First Posted
June 25, 2015
Study Start
May 1, 2015
Primary Completion
November 1, 2015
Study Completion
February 1, 2016
Last Updated
September 25, 2018
Record last verified: 2018-09