IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Cardiometabolic Response to a Sodium-bicarbonated Mineral Water
This study has been completed.
Sponsor:
National Research Council, Spain
Information provided by (Responsible Party):
M Pilar Vaquero, National Research Council, Spain
ClinicalTrials.gov Identifier:
NCT02480816
First received: June 22, 2015
Last updated: June 29, 2015
Last verified: June 2015
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
| Dyslipidemia | Dietary Supplement: Mineral water |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
Resource links provided by NLM:
Further study details as provided by M Pilar Vaquero, National Research Council, Spain:
Primary Outcome Measures:
- LDL-cholesterol [ Time Frame: Baseline ]
- LDL-cholesterol [ Time Frame: 4 weeks ]
- LDL-cholesterol [ Time Frame: 8 weeks ]
Secondary Outcome Measures:
- 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 ]
- Serum aldosterone [ Time Frame: Baseline ]
- Serum aldosterone [ Time Frame: 8 weeks ]
- BMI [ Time Frame: Baseline ]
- BMI [ Time Frame: 4 weeks ]
- BMI [ Time Frame: 8 weeks ]
- Dietary energy intake [ Time Frame: Baseline ]
- Dietary energy intake [ Time Frame: 8 weeks ]
- Dietary protein intake [ Time Frame: Baseline ]
- Dietary protein intake [ Time Frame: 8 weeks ]
- Dietary fat intake [ Time Frame: Baseline ]
- Dietary fat intake [ Time Frame: 8 weeks ]
- Dietary cholesterol intake [ Time Frame: Baseline ]
- Dietary cholesterol intake [ Time Frame: 8 weeks ]
- Dietary carbohydrate intake [ Time Frame: Baseline ]
- Dietary carbohydrate intake [ Time Frame: 8 weeks ]
| Enrollment: | 65 |
| Study Start Date: | March 2014 |
| Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
No Contacts or Locations Provided
More Information
| Responsible Party: | M Pilar Vaquero, Scientific researcher, National Research Council, Spain |
| ClinicalTrials.gov Identifier: | NCT02480816 History of Changes |
| Other Study ID Numbers: |
BW-13 |
| Study First Received: | June 22, 2015 |
| Last Updated: | June 29, 2015 |
Additional relevant MeSH terms:
|
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on July 14, 2017