Effects of DASH Diet on Corticosteroids Medication Use

Phase 3

Completed

• Conditions: Nutritional and Metabolic Disease
• Interventions: Other: nutrition intervention

• Registration Number: NCT01762267
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Study First Submitted: 2012-12-01
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-04
• Last Update Submitted: 2013-01-04
• Study First Posted: 2013-01-07
• Last Update Posted: 2013-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

• patients who were on corticosteroid therapy

Exclusion Criteria

• refuse to follow the visits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diet intervention, DASH diet	nutrition intervention	intervention: nutrition intervention: DASH diet

Primary Outcome Measures

Name	Time	Method
the amount of weight reduction and change of blood pressure	up to 10 weeks	weight (kg) body mass index (kg/m2) blood pressure (mmHg)

Secondary Outcome Measures

Name	Time	Method
lipid profile, fasting blood glucose	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).

Trial Locations

Locations (1)

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