- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02295852
Increasing Calcium Dietary Intake Helps to Control Blood Presure and Body Weight
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Liberato Aldo Ferrara, MD
- Phone Number: 2302 +39081746
- Email: ferrara@unina.it
Study Locations
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-
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Naples, Italy, 80131
- Hypertention Outpatient Clinic Dept. of Clinica Medica; Federico 2nd University of Naples
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Contact:
- Aldo L Ferrara, MD
- Phone Number: +390817462302
- Email: ferrara@unina.it
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Contact:
- Delia Pacioni, Dietician
- Phone Number: +390817463688
- Email: pacioni@unina.it
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Sub-Investigator:
- Valentina Di Fronzo, MD
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Sub-Investigator:
- Barbara Russo, MD
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Sub-Investigator:
- Viviana Carlino, MD
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Sub-Investigator:
- Francesco Gargiulo, MD
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Sub-Investigator:
- Enza Speranza, Nutritionist
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A: LOW-SODIUM LOW LIPID CALCIUM RICH DIET
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;
|
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
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Active Comparator: Group B: LOW-SODIUM LOW LIPID DIET
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antihypertensive effects as measured by BP measurements
Time Frame: after 3-months of dietary treatment
|
Measurements of blood pressure by sphygmomanometer.
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after 3-months of dietary treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects on body weight as measured by scale
Time Frame: after 3-months of dietary treatment
|
measurements of body weight
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after 3-months of dietary treatment
|
Effects on glucose metabolism as measured by fasting blood glucose
Time Frame: after 3 months of dietary treatment
|
measurements of fasting blood glucose
|
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
|
measurements of serum cholesterol, HDL-cholesterol, total triglycerides
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after 3 months of dietary treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Long term feasibility of the diet as measured by adherence to dietary treatment
Time Frame: after 1 yearof dietary treatment
|
to evaluate if this diet is palatable enough to be prescribed in a long term study by an appropriate questionnaire
|
after 1 yearof dietary treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Liberato Aldo Ferrara, MD, Dept. of Medicine and Surgery; Federico 2nd University of Naples
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 003 (NuSkin International)
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