Increasing Calcium Dietary Intake Helps to Control Blood Presure and Body Weight
Primary Purpose
Hypertension, Body Weight
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
LOW-SODIUM LOW LIPID CALCIUM RICH DIET
LOW-SODIUM LOW LIPID DIET
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Low-sodium calcium enriched diet, Low-sodium diet, Glucose and lipid metabolims
Eligibility Criteria
Inclusion Criteria:
- age 30-70 years
- IMC >28 and < 35 kg/m2
- pharmacological treatment unchanged in the last 3 months
Exclusion Criteria:
- chronic kidney disease
- liver or chronic inflammatory bowel disease
- tumor
Sites / Locations
- Hypertention Outpatient Clinic Dept. of Clinica Medica; Federico 2nd University of Naples
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A: LOW-SODIUM LOW LIPID CALCIUM RICH DIET
Group B: LOW-SODIUM LOW LIPID DIET
Arm Description
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;
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.
Outcomes
Primary Outcome Measures
Antihypertensive effects as measured by BP measurements
Measurements of blood pressure by sphygmomanometer.
Secondary Outcome Measures
Effects on body weight as measured by scale
measurements of body weight
Effects on glucose metabolism as measured by fasting blood glucose
measurements of fasting blood glucose
Effects on lipid metabolism as measured by measurements of serum cholesterol, triglycerides and HDL-cholesterol
measurements of serum cholesterol, HDL-cholesterol, total triglycerides
Full Information
NCT ID
NCT02295852
First Posted
November 7, 2014
Last Updated
November 17, 2014
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT02295852
Brief Title
Increasing Calcium Dietary Intake Helps to Control Blood Presure and Body Weight
Official Title
Effects of Changes in Calcium Dietary Intake on Blood Pressure and Body Weight Control
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Body Weight
Keywords
Low-sodium calcium enriched diet, Low-sodium diet, Glucose and lipid metabolims
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: LOW-SODIUM LOW LIPID CALCIUM RICH DIET
Arm Type
Experimental
Arm Description
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;
Arm Title
Group B: LOW-SODIUM LOW LIPID DIET
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
LOW-SODIUM LOW LIPID CALCIUM RICH DIET
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
LOW-SODIUM LOW LIPID DIET
Intervention Description
2. 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
Primary Outcome Measure Information:
Title
Antihypertensive effects as measured by BP measurements
Description
Measurements of blood pressure by sphygmomanometer.
Time Frame
after 3-months of dietary treatment
Secondary Outcome Measure Information:
Title
Effects on body weight as measured by scale
Description
measurements of body weight
Time Frame
after 3-months of dietary treatment
Title
Effects on glucose metabolism as measured by fasting blood glucose
Description
measurements of fasting blood glucose
Time Frame
after 3 months of dietary treatment
Title
Effects on lipid metabolism as measured by measurements of serum cholesterol, triglycerides and HDL-cholesterol
Description
measurements of serum cholesterol, HDL-cholesterol, total triglycerides
Time Frame
after 3 months of dietary treatment
Other Pre-specified Outcome Measures:
Title
Long term feasibility of the diet as measured by adherence to dietary treatment
Description
to evaluate if this diet is palatable enough to be prescribed in a long term study by an appropriate questionnaire
Time Frame
after 1 yearof dietary treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 30-70 years
IMC >28 and < 35 kg/m2
pharmacological treatment unchanged in the last 3 months
Exclusion Criteria:
chronic kidney disease
liver or chronic inflammatory bowel disease
tumor
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liberato Aldo Ferrara, MD
Phone
+39081746
Ext
2302
Email
ferrara@unina.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liberato Aldo Ferrara, MD
Organizational Affiliation
Dept. of Medicine and Surgery; Federico 2nd University of Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hypertention Outpatient Clinic Dept. of Clinica Medica; Federico 2nd University of Naples
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aldo L Ferrara, MD
Phone
+390817462302
Email
ferrara@unina.it
First Name & Middle Initial & Last Name & Degree
Delia Pacioni, Dietician
Phone
+390817463688
Email
pacioni@unina.it
First Name & Middle Initial & Last Name & Degree
Valentina Di Fronzo, MD
First Name & Middle Initial & Last Name & Degree
Barbara Russo, MD
First Name & Middle Initial & Last Name & Degree
Viviana Carlino, MD
First Name & Middle Initial & Last Name & Degree
Francesco Gargiulo, MD
First Name & Middle Initial & Last Name & Degree
Enza Speranza, Nutritionist
12. IPD Sharing Statement
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Increasing Calcium Dietary Intake Helps to Control Blood Presure and Body Weight
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