DyslipidemiaNCT02480816
Cardiometabolic Response to a Sodium-bicarbonated Mineral Water
A study testing Mineral water in people with Dyslipidemia, run by National Research Council, Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Mineral water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 1 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults, men and women >18 and ≤ 45 years
- Total-cholesterol > 200 mg/dL and < 300 mg/dL
Who cannot join
- 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
Show all 11Show fewer
- 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)
About this study
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.
- Conditions
- Dyslipidemia
- Being tested
- Mineral water
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral waterDietary supplement
Intake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design
| Study group | Role | What they receive |
|---|---|---|
| Bicarbonated mineral water (BW) | Experimental | Bicarbonated mineral water Receives: Dietary Supplement: Mineral water |
| Control mineral water (CW) | Active comparator | Mineral water low in mineral content (control) Receives: Dietary Supplement: Mineral water |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterol
Measured: Baseline
LDL-cholesterol
Measured: 4 weeks
LDL-cholesterol
Measured: 8 weeks
Secondary outcomes (55)
Total-cholesterol
Measured: Baseline
Total-cholesterol
Measured: 4 weeks
Total-cholesterol
Measured: 8 weeks
Triglycerides
Measured: Baseline
Triglycerides
Measured: 4 weeks
Triglycerides
Measured: 8 weeks
HDL-cholesterol
Measured: Baseline
HDL-cholesterol
Measured: 4 weeks
HDL-cholesterol
Measured: 8 weeks
Apolipoprotein A
Measured: Baseline
Apolipoprotein A
Measured: 4 weeks
Apolipoprotein A
Measured: 8 weeks
Apolipoprotein B
Measured: Baseline
Apolipoprotein B
Measured: 4 weeks
Apolipoprotein B
Measured: 8 weeks
Glucose
Measured: Baseline
Glucose
Measured: 4 weeks
Glucose
Measured: 8 weeks
Insulin
Measured: Baseline
Insulin
Measured: 4 weeks
Insulin
Measured: 8 weeks
Urine creatinin
Measured: Baseline
Urine creatinin
Measured: 8 weeks
Urine calcium
Measured: Baseline
Urine calcium
Measured: 8 weeks
Urine potassium
Measured: Baseline
Urine potassium
Measured: 8 weeks
Urine sodium
Measured: Baseline
Urine sodium
Measured: 8 weeks
Urine pH
Measured: Baseline
Urine pH
Measured: 8 weeks
Systolic Blood Pressure
Measured: Baseline
Systolic Blood Pressure
Measured: 4 weeks
Systolic Blood Pressure
Measured: 8 weeks
Diastolic Blood Pressure
Measured: Baseline
Diastolic Blood Pressure
Measured: 4 weeks
Diastolic Blood Pressure
Measured: 8 weeks
Oxidized LDL
Measured: Baseline
Oxidized LDL
Measured: 4 weeks
Oxidized LDL
Measured: 8 weeks
Serum aldosterone
Measured: Baseline
Serum aldosterone
Measured: 8 weeks
BMI
Measured: Baseline
BMI
Measured: 4 weeks
BMI
Measured: 8 weeks
Dietary energy intake
Measured: Baseline
Dietary energy intake
Measured: 8 weeks
Dietary protein intake
Measured: Baseline
Dietary protein intake
Measured: 8 weeks
Dietary fat intake
Measured: Baseline
Dietary fat intake
Measured: 8 weeks
Dietary cholesterol intake
Measured: Baseline
Dietary cholesterol intake
Measured: 8 weeks
Dietary carbohydrate intake
Measured: Baseline
Dietary carbohydrate intake
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start1 May 2015
- Primary completion1 Nov 2015
- Study completion1 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Responsible party
- Principal investigator, M Pilar Vaquero, National Research Council, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480816
- Sponsor's protocol ID
- BW-13
- Status last verified
- Sep 2018
- First submitted
- 22 Jun 2015
- Last updated
- 25 Sep 2018
- Results posted
- No
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.
PubMed 27367723
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Response to a Sodium-bicarbonated Mineral Water
- ClinicalTrials.gov ID
- NCT02480816
- Acronym / sponsor ID
- BW-13
- Conditions
- Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Nov 2015 (actual)
- Study completion
- 1 Feb 2016 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bicarbonated mineral water (BW) | Experimental | Dietary Supplement: Mineral waterBicarbonated mineral water |
| Control mineral water (CW) | Active comparator | Dietary Supplement: Mineral waterMineral water low in mineral content (control) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults, men and women >18 and ≤ 45 years
- Total-cholesterol > 200 mg/dL and < 300 mg/dL
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mineral waterIntake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design | Dietary supplement | Bicarbonated mineral water (BW), Control mineral water (CW) |
Primary outcome
LDL-cholesterol
Time frame: Baseline
LDL-cholesterol
Time frame: 4 weeks
LDL-cholesterol
Time frame: 8 weeks
55 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
Apolipoprotein A
Time frame: 8 weeks
Apolipoprotein B
Time frame: Baseline
Apolipoprotein B
Time frame: 4 weeks
Apolipoprotein B
Time frame: 8 weeks
Glucose
Time frame: Baseline
Glucose
Time frame: 4 weeks
Glucose
Time frame: 8 weeks
Insulin
Time frame: Baseline
Insulin
Time frame: 4 weeks
Insulin
Time frame: 8 weeks
Urine creatinin
Time frame: Baseline
Urine creatinin
Time frame: 8 weeks
Urine calcium
Time frame: Baseline
Urine calcium
Time frame: 8 weeks
Urine potassium
Time frame: Baseline
Urine potassium
Time frame: 8 weeks
Urine sodium
Time frame: Baseline
Urine sodium
Time frame: 8 weeks
Urine pH
Time frame: Baseline
Urine pH
Time frame: 8 weeks
Systolic Blood Pressure
Time frame: Baseline
Systolic Blood Pressure
Time frame: 4 weeks
Systolic Blood Pressure
Time frame: 8 weeks
Diastolic Blood Pressure
Time frame: Baseline
Diastolic Blood Pressure
Time frame: 4 weeks
Diastolic Blood Pressure
Time frame: 8 weeks
Oxidized LDL
Time frame: Baseline
Oxidized LDL
Time frame: 4 weeks
Oxidized LDL
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Results publication: PubMed 27367723Toxqui 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mineral water in people with Dyslipidemia, run by National Research Council, Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-cholesterol (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02480816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.