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

NCT02295852 | Unknown DMC

• 1 other identifier: 003
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Body Weight

Keywords

Low-sodium calcium enriched diet; Low-sodium diet; Glucose and lipid metabolims

Outcome Measures

Primary Outcomes (1)

• Antihypertensive effects as measured by BP measurements

  Measurements of blood pressure by sphygmomanometer.

  after 3-months of dietary treatment

Secondary Outcomes (3)

• Effects on body weight as measured by scale

  after 3-months of dietary treatment

• Effects on glucose metabolism as measured by fasting blood glucose

  after 3 months of dietary treatment

• Effects on lipid metabolism as measured by measurements of serum cholesterol, triglycerides and HDL-cholesterol

  after 3 months of dietary treatment

Other Outcomes (1)

• Long term feasibility of the diet as measured by adherence to dietary treatment

  after 1 yearof dietary treatment

Study Arms (2)

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;

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.

Dietary Supplement: LOW-SODIUM LOW LIPID DIET

Interventions

LOW-SODIUM LOW LIPID CALCIUM RICH DIET DIETARY_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

Group A: LOW-SODIUM LOW LIPID CALCIUM RICH DIET

LOW-SODIUM LOW LIPID DIET DIETARY_SUPPLEMENT

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

Group B: LOW-SODIUM LOW LIPID DIET

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 30-70 years
• IMC \>28 and \< 35 kg/m2
• pharmacological treatment unchanged in the last 3 months

You may not qualify if:

• chronic kidney disease
• liver or chronic inflammatory bowel disease
• tumor

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Hypertention Outpatient Clinic Dept. of Clinica Medica; Federico 2nd University of Naples

Naples, Naples, 80131, Italy

Location

MeSH Terms

Conditions

Hypertension; Body Weight

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Liberato Aldo Ferrara, MD

  Dept. of Medicine and Surgery; Federico 2nd University of Naples

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liberato Aldo Ferrara, MD

CONTACT

+39081746; ferrara@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 20, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

IT (1)