HypertensionNCT02295852
Increasing Calcium Dietary Intake Helps to Control Blood Presure and Body Weight
A study testing LOW-SODIUM LOW LIPID CALCIUM RICH DIET and LOW-SODIUM LOW LIPID DIET in people with Hypertension and Body Weight, run by Federico II University at 1 site in Italy.
Trial summary
Mediterranean diet is relatively poor in calcium (about 700 mg/daily) whilst there are several reports indicating beneficial effects of calcium-rich diets. Aim of the preset study is to evaluate the effects of a low-sodium, low-lipid diet enriched in calcium, mainly from vegetables instead of dairy products, on blood… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hypertension, Body Weight
- What is being tested?
- LOW-SODIUM LOW LIPID CALCIUM RICH DIET and LOW-SODIUM LOW LIPID DIET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2014to Jul 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 30-70 years
- IMC >28 and < 35 kg/m2
- pharmacological treatment unchanged in the last 3 months
Who cannot join
- chronic kidney disease
- liver or chronic inflammatory bowel disease
- tumor
Trial locations and contacts
1 site in 1 country.
Italy1 site
Hypertention Outpatient Clinic Dept. of Clinica Medica; Federico 2nd University of Naples
Naples, Naples, 80131
Aldo L Ferrara, MD, +390817462302, ferrara@unina.it
Delia Pacioni, Dietician, +390817463688, pacioni@unina.it
About this study
Official title: Effects of Changes in Calcium Dietary Intake on Blood Pressure and Body Weight Control
Mediterranean diet is relatively poor in calcium (about 700 mg/daily) whilst there are several reports indicating beneficial effects of calcium-rich diets. Aim of the preset study is to evaluate the effects of a low-sodium, low-lipid diet enriched in calcium, mainly from vegetables instead of dairy products, on blood pressure, body weight a main parameters of the glucose and lipid metabolisms.
This study is a randomized, parallel group trial that will be performed in the Outpatient Clinic. At least 150 patients with arterial hypertension and/or increased body weight (IMC> 28 kg/m2) will enter the study program. After a 3 month low-lipid low-salt diet that will be prescribed to all patients, they will be divided in two groups. The first will change the diet to that similar for total calories, percent composition of macronutrients and salt but enriched in calcium (about 1200 mg/daily) whilst the alternative group will continue the first diet. The observation period will be of 1 year with anthropometric (body weight and height, waist circumference), hemodynamic (blood pressure and heart rate) and metabolic (cholesterol, triglycerides, fasting blood glucose, uric acid, calcium, phosphorus, sodium and potassium) controls after 3-6 and 12 months.
Read the detailed description
The DASH Study showed that the antihypertensive effects of a low-salt, low-lipid diet were significantly potentiated when the diet was enriched in calcium. This target may be reached either increasing the daily consumption of low-lipid milk and dairy products or increasing the daily consumption of calcium-rich vegetables.
In the Italian population the mean daily consumption of calcium is rather low, not exceeding 700 mg/daily whilst it would be desirable a daily consumption of 1200 mg/daily. Unfortunately there are in Italy very few dairy products (particularly low-lipid cheese) that would ensure a variable and palatable calcium-rich diet.
Aims of the present study are:
- to prepare a low-sodium (about 3 g/daily) diet enrich in calcium (about 1200 mg/daily) and to compare the effects on blood pressure with those of a low-sodium diet similar to it in macronutrients but with a calcium content typical of the Mediterranean diet (no more than 700 mg/daily) (see Table 1);
- to verify if this diet is able to improve the control of body weight and of the main parameters of the glucose and lipid metabolisms;
- to evaluate if this diet is palatable enough to be prescribed in a long term study.
Patients:
At least 150 patients with arterial hypertension and/or overweight /obesity (IMC > 28 kg/m2) will be enrolled.
Methods:
- evaluation of nutritional habits by an adequate frequency questionnaire at baseline, after a 3-month low-lipid low-sodium diet;
- anthropometric measures (body weight, height, waist circumference);
- measurements of blood pressure and heart rate;
- measurements of serum total and HDL cholesterol serum triglycerides, fasting blood glucose, serum sodium potassium calcium and phosphorus.
Design of the study:
This is a randomized parallel-group study performed in the Outpatient Clinic. Patients enrolled in the study will be prescribed a low-sodium low-lipid diet for 3 months. At the end of the first phase they will be randomly divided in two groups:
- Group A: patients will change their diet in a diet similar for total daily calories, sodium and macronutrients but enriched in calcium (1200 mg/daily) and will be followed up to 1 year with an intermediate control after the first 3 months;
- Group B: patients will continue the low-lipid, low-sodium diet up to 1 year with an intermediate control after the first 3 months.
At baseline, after 3, 6 and 12 months of observation, patients will repeat the measurements 1-4 described in the Methods.
Composition in macro and micronutrients of the two diets
NUTRIENTS LOW-SODIUM DIET LOW-SODIUN CALCIUM- ENRICHED DIET PROTEINS (%) 17 17 LIPIDS (%) 27 28 SATURATED FATTY ACIDS (%) 7 7 MONOUNSATURATED (%) 16 17 POLTYUNSATURATED (%) 4 4 CHOLESTEROL ( mg) 132 140 CARBOHYDRATES (%) 56 54 SOLUBLE CHO (%) 18 17 FIBRE (g) 39 42 Na (mg) 1397 1377 K (mg) 3973 4067 Fe (mg) 16 21 Ca (mg) 650 1211 P (mg) 1285 1501
- Conditions
- Hypertension, Body Weight
- Being tested
- LOW-SODIUM LOW LIPID CALCIUM RICH DIET, LOW-SODIUM LOW LIPID DIET
- Keywords
- Low-sodium calcium enriched diet, Low-sodium diet, Glucose and lipid metabolims
- Medical subject headings
- Hypertension, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOW-SODIUM LOW LIPID CALCIUM RICH DIETDietary supplement
1.Composition of the diet: Proteins 17%, Total lipids 28%, Saturated Fatty Acids 7%, Carbohydrates 54%, Fibers 42 g, Sodium 1377 mg, potassium 4067mg, Calcium 1211 mg
LOW-SODIUM LOW LIPID DIETDietary supplement
- Composition of the diet: Proteins 17%, Total lipids 27%, Saturated Fatty Acids 7%, Carbohydrates 56%, Fibers 39 g, Sodium 1397 mg, potassium 3973 mg, Calcium 650 mg
| Study group | Role | What they receive |
|---|---|---|
| Group A: LOW-SODIUM LOW LIPID CALCIUM RICH DIET | Experimental | Experimental Group A: patients will change their diet in a diet similar for total daily calories, sodium and macronutrients but enriched in calcium (1200 mg/daily) and will be followed up to 1 year with an intermediate control after the first 3 months; Receives: Dietary Supplement: LOW-SODIUM LOW LIPID CALCIUM RICH DIET |
| Group B: LOW-SODIUM LOW LIPID DIET | Active comparator | Experimental Group B: patients will continue the low-lipid, low-sodium diet up to 1 year with an intermediate control after the first 3 months. Receives: Dietary Supplement: LOW-SODIUM LOW LIPID DIET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antihypertensive effects as measured by BP measurements
Measurements of blood pressure by sphygmomanometer.
Measured: after 3-months of dietary treatment
Secondary outcomes (3)
Effects on body weight as measured by scale
measurements of body weight
Measured: after 3-months of dietary treatment
Effects on glucose metabolism as measured by fasting blood glucose
measurements of fasting blood glucose
Measured: after 3 months of dietary treatment
Effects on lipid metabolism as measured by measurements of serum cholesterol, triglycerides and HDL-cholesterol
measurements of serum cholesterol, HDL-cholesterol, total triglycerides
Measured: after 3 months of dietary treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferrara Liberato Aldo, Federico II University
- Investigators
- Liberato Aldo Ferrara, MD, Principal investigator, Dept. of Medicine and Surgery; Federico 2nd University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295852
- Sponsor's protocol ID
- 003
- Status last verified
- Nov 2014
- First submitted
- 7 Nov 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Changes in Calcium Dietary Intake on Blood Pressure and Body Weight Control
- ClinicalTrials.gov ID
- NCT02295852
- Acronym / sponsor ID
- 003
- Conditions
- Hypertension, Body Weight
- Keywords
- Low-sodium calcium enriched diet, Low-sodium diet, Glucose and lipid metabolims
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 20 Nov 2014 (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.
Mediterranean diet is relatively poor in calcium (about 700 mg/daily) whilst there are several reports indicating beneficial effects of calcium-rich diets. Aim of the preset study is to evaluate the effects of a low-sodium, low-lipid diet enriched in calcium, mainly from vegetables instead of dairy products, on blood pressure, body weight a main parameters of the glucose and lipid metabolisms.
This study is a randomized, parallel group trial that will be performed in the Outpatient Clinic. At least 150 patients with arterial hypertension and/or increased body weight (IMC> 28 kg/m2) will enter the study program. After a 3 month low-lipid low-salt diet that will be prescribed to all patients, they will be divided in two groups. The first will change the diet to that similar for total calories, percent composition of macronutrients and salt but enriched in calcium (about 1200 mg/daily) whilst the alternative group will continue the first diet. The observation period will be of 1 year with anthropometric (body weight and height, waist circumference), hemodynamic (blood pressure and heart rate) and metabolic (cholesterol, triglycerides, fasting blood glucose, uric acid, calcium, phosphorus, sodium and potassium) controls after 3-6 and 12 months.
Detailed description
The DASH Study showed that the antihypertensive effects of a low-salt, low-lipid diet were significantly potentiated when the diet was enriched in calcium. This target may be reached either increasing the daily consumption of low-lipid milk and dairy products or increasing the daily consumption of calcium-rich vegetables.
In the Italian population the mean daily consumption of calcium is rather low, not exceeding 700 mg/daily whilst it would be desirable a daily consumption of 1200 mg/daily. Unfortunately there are in Italy very few dairy products (particularly low-lipid cheese) that would ensure a variable and palatable calcium-rich diet.
Aims of the present study are:
- to prepare a low-sodium (about 3 g/daily) diet enrich in calcium (about 1200 mg/daily) and to compare the effects on blood pressure with those of a low-sodium diet similar to it in macronutrients but with a calcium content typical of the Mediterranean diet (no more than 700 mg/daily) (see Table 1);
- to verify if this diet is able to improve the control of body weight and of the main parameters of the glucose and lipid metabolisms;
- to evaluate if this diet is palatable enough to be prescribed in a long term study.
Patients:
At least 150 patients with arterial hypertension and/or overweight /obesity (IMC > 28 kg/m2) will be enrolled.
Methods:
- evaluation of nutritional habits by an adequate frequency questionnaire at baseline, after a 3-month low-lipid low-sodium diet;
- anthropometric measures (body weight, height, waist circumference);
- measurements of blood pressure and heart rate;
- measurements of serum total and HDL cholesterol serum triglycerides, fasting blood glucose, serum sodium potassium calcium and phosphorus.
Design of the study:
This is a randomized parallel-group study performed in the Outpatient Clinic. Patients enrolled in the study will be prescribed a low-sodium low-lipid diet for 3 months. At the end of the first phase they will be randomly divided in two groups:
- Group A: patients will change their diet in a diet similar for total daily calories, sodium and macronutrients but enriched in calcium (1200 mg/daily) and will be followed up to 1 year with an intermediate control after the first 3 months;
- Group B: patients will continue the low-lipid, low-sodium diet up to 1 year with an intermediate control after the first 3 months.
At baseline, after 3, 6 and 12 months of observation, patients will repeat the measurements 1-4 described in the Methods.
Composition in macro and micronutrients of the two diets
NUTRIENTS LOW-SODIUM DIET LOW-SODIUN CALCIUM- ENRICHED DIET PROTEINS (%) 17 17 LIPIDS (%) 27 28 SATURATED FATTY ACIDS (%) 7 7 MONOUNSATURATED (%) 16 17 POLTYUNSATURATED (%) 4 4 CHOLESTEROL ( mg) 132 140 CARBOHYDRATES (%) 56 54 SOLUBLE CHO (%) 18 17 FIBRE (g) 39 42 Na (mg) 1397 1377 K (mg) 3973 4067 Fe (mg) 16 21 Ca (mg) 650 1211 P (mg) 1285 1501
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: LOW-SODIUM LOW LIPID CALCIUM RICH DIET | Experimental | Dietary Supplement: LOW-SODIUM LOW LIPID CALCIUM RICH DIETExperimental Group A: patients will change their diet in a diet similar for total daily calories, sodium and macronutrients but enriched in calcium (1200 mg/daily) and will be followed up to 1 year with an intermediate control after the first 3 months; |
| Group B: LOW-SODIUM LOW LIPID DIET | Active comparator | Dietary Supplement: LOW-SODIUM LOW LIPID DIETExperimental Group B: patients will continue the low-lipid, low-sodium diet up to 1 year with an intermediate control after the first 3 months. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 30-70 years
- IMC >28 and < 35 kg/m2
- pharmacological treatment unchanged in the last 3 months
Key exclusion criteria (3 listed)
- chronic kidney disease
- liver or chronic inflammatory bowel disease
- tumor
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 |
|---|---|---|
| LOW-SODIUM LOW LIPID CALCIUM RICH DIET1.Composition of the diet: Proteins 17%, Total lipids 28%, Saturated Fatty Acids 7%, Carbohydrates 54%, Fibers 42 g, Sodium 1377 mg, potassium 4067mg, Calcium 1211 mg | Dietary supplement | Group A: LOW-SODIUM LOW LIPID CALCIUM RICH DIET |
| LOW-SODIUM LOW LIPID DIET2. Composition of the diet: Proteins 17%, Total lipids 27%, Saturated Fatty Acids 7%, Carbohydrates 56%, Fibers 39 g, Sodium 1397 mg, potassium 3973 mg, Calcium 650 mg | Dietary supplement | Group B: LOW-SODIUM LOW LIPID DIET |
Primary outcome
Antihypertensive effects as measured by BP measurements
Time frame: after 3-months of dietary treatment
Measurements of blood pressure by sphygmomanometer.
3 secondary outcomes
Effects on body weight as measured by scale
Time frame: after 3-months of dietary treatment
Effects on glucose metabolism as measured by fasting blood glucose
Time frame: after 3 months of dietary treatment
Effects on lipid metabolism as measured by measurements of serum cholesterol, triglycerides and HDL-cholesterol
Time frame: after 3 months of dietary treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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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.
Liberato Aldo Ferrara, MD principal investigator
Dept. of Medicine and Surgery; Federico 2nd University of Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOW-SODIUM LOW LIPID CALCIUM RICH DIET and LOW-SODIUM LOW LIPID DIET in people with Hypertension and Body Weight, run by Federico II University at 1 site in Italy.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liberato Aldo Ferrara, MD (+39081746 ext. 2302, ferrara@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antihypertensive effects as measured by BP measurements (time frame: after 3-months of dietary treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2014.