Nutritional and Metabolic DiseasePhase 3NCT01762267
Effects of DASH Diet on Corticosteroids Medication Use
A Phase 3 study testing nutrition intervention in people with Nutritional and Metabolic Disease, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use. Read more about this study
- Who is it for?
- Ages 27 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutritional and Metabolic Disease
- What is being tested?
- nutrition intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIran
- Study dates
- Jan 2011to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who were on corticosteroid therapy
Who cannot join
- refuse to follow the visits
Trial locations and contacts
1 site in 1 country.
Iran1 site
1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science
Isfahan
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutritional and Metabolic Disease
- Being tested
- nutrition intervention
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition interventionOther
DASH diet control diet
| Study group | Role | What they receive |
|---|---|---|
| diet intervention, DASH diet | Active comparator | intervention: nutrition intervention: DASH diet Receives: Other: nutrition intervention |
| not intervention, control diet | No intervention | control weight loss diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of weight reduction and change of blood pressure
weight (kg) body mass index (kg/m2) blood pressure (mmHg)
Measured: up to 10 weeks
Secondary outcomes (1)
lipid profile, fasting blood glucose
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).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional and Metabolic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Azadbakht, Isfahan University of Medical Sciences
- Investigators
- Leila azadbakht, PhD, Study director, 1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science, Isfahan, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762267
- Sponsor's protocol ID
- DASH in corton therapy
- Status last verified
- Jan 2013
- First submitted
- 1 Dec 2012
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Beneficiary Effects of Dietary Approaches to Stop Hypertension (DASH) on the Metabolic Aeffects of Corticosteroids Medications Use
- ClinicalTrials.gov ID
- NCT01762267
- Acronym / sponsor ID
- DASH in corton therapy
- Conditions
- Nutritional and Metabolic Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diet intervention, DASH diet | Active comparator | Other: nutrition interventionintervention: nutrition intervention: DASH diet |
| not intervention, control diet | No intervention | –control weight loss diet |
Who may qualify
- Ages
- 27 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients who were on corticosteroid therapy
Key exclusion criteria (1 listed)
- refuse to follow the visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutrition interventionDASH diet control diet | Other | diet intervention, DASH diet |
Primary outcome
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)
1 secondary outcome
lipid profile, fasting blood glucose
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leila azadbakht, PhD study director
1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science, Isfahan, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nutrition intervention in people with Nutritional and Metabolic Disease, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the amount of weight reduction and change of blood pressure (time frame: up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.