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Increasing Calcium Dietary Intake Helps to Control Blood Presure and Body Weight

NCT02295852 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-11-20

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

LOW-SODIUM LOW LIPID CALCIUM RICH DIET

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

DIETARY_SUPPLEMENT

LOW-SODIUM LOW LIPID DIET

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

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Liberato Aldo Ferrara, MD · Dept. of Medicine and Surgery; Federico 2nd University of Naples

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-12-31
Completion
2016-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02295852 on ClinicalTrials.gov