Effects of DASH Diet on Corticosteroids Medication Use

January 4, 2013 updated by: Leila Azadbakht, Isfahan University of Medical Sciences

Phase 3 Study of Beneficiary Effects of Dietary Approaches to Stop Hypertension (DASH) on the Metabolic Aeffects of Corticosteroids Medications Use

To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use.

Design: A randomized clinical trial was undertaken in 60 patients on corticosteroid therapy for 10 weeks. Patients were randomly assigned to a DASH or control diet. Fasting blood sample were measured to determine blood glucose and lipid profile. Blood pressure and anthropometric measurements were measured based on the standard guidelines.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Isfahan, Iran, Islamic Republic of
        • 1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

27 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients who were on corticosteroid therapy

Exclusion Criteria:

  • refuse to follow the visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: diet intervention, DASH diet
intervention: nutrition intervention: DASH diet
Other: nutrition intervention
DASH diet control diet
No Intervention: not intervention, control diet
control weight loss diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the amount of weight reduction and change of blood pressure
Time Frame: up to 10 weeks
weight (kg) body mass index (kg/m2) blood pressure (mmHg)
up to 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lipid profile, fasting blood glucose
Time Frame: 10 weeks
measurement of LDL-C (mg/dl), HDL-C (mg/dl), triglyceride (mg/dl), total cholesterol (mg/dl), fasting blood glucose(mg/dl), by the analysis of blood samples and blood pressure(mmHg) and weight (kg), waist circumference (cm), body mass index (kg/m2).
10 weeks

Other Outcome Measures

Outcome Measure
Time Frame
lipid profile (mg/dl), fasting blood glucose (mg/dl), blood pressure (mmHg), weight reduction (kg)
Time Frame: july
july

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Study Director: Leila azadbakht, PhD, 1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science, Isfahan, Iran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

December 1, 2012

First Submitted That Met QC Criteria

January 4, 2013

First Posted (Estimate)

January 7, 2013

Study Record Updates

Last Update Posted (Estimate)

January 7, 2013

Last Update Submitted That Met QC Criteria

January 4, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DASH in corton therapy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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