- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05997251
The Relationship of DASH and Mediterranean Diet Score With Serum Adiponectin Levels in Patients With Spinal Cord Injury
The aim of this study is to reveal the relationship of DASH and Mediterranean diet score with anthropometric measurements and serum adiponectin level in individuals with spinal cord injury. This research was planned as a cross-sectional, case-control study. With the data to be obtained from the research, information will be obtained about the hormonal or biochemical basis of metabolic disorders such as atherosclerosis and insulin resistance that may occur in individuals with spinal cord injury in the long term.
20 individuals with Spinal Cord Injury will be included in the study, and the results of the patients will be compared with 20 healthy individuals. In order to determine the food consumption status of the patients, a 1-day food consumption record will be requested. DASH diet score and Mediterranean diet score will be calculated from dietary records. After 8 hours of fasting, 3 ml of peripheral blood will be taken for the measurement of adiponectin between 08:00 and 09:00 in the morning from the individuals in the study and control groups. Adiponectin level will be measured and its correlation with DASH diet score and Mediterranean diet score will be examined.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Ankara, Turkey
- Ankara Bilkent City Hospital Physical Treatment and Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Inclusion criteria (Study group)
- Having spent at least 6 months after spinal cord injury
- 1st motor neuron injury
- Being between the ages of 18-65
- Giving consent to participate in the study Inclusion criteria (Control group)
- Being between the ages of 18-65
- Giving consent to participate in the study
Exclusion Criteria:
Exclusion criteria (Study group)
- Having an additional disease to the spinal cord injury
- Having a 2nd motor neuron lesion
Exclusion criteria (Control group)
• Having any disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy group
|
Checking and receiving the 1-day food consumption record recorded by the patient by the researcher
Adiponectin level will be measured for each group
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Patients with spinal cord injury
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Checking and receiving the 1-day food consumption record recorded by the patient by the researcher
Adiponectin level will be measured for each group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adiponectin level
Time Frame: Will be measured at inclusion
|
Adiponectin level will be measured from peripheral blood
|
Will be measured at inclusion
|
DASH diet score
Time Frame: Will be measured at inclusion from one day dietary record
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Will be measured at inclusion from one day dietary record
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Will be measured at inclusion from one day dietary record
|
Mediterrenian diet score
Time Frame: Will be measured at inclusion from one day dietary record
|
Will be measured at inclusion from one day dietary record
|
Will be measured at inclusion from one day dietary record
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole blood count
Time Frame: Will be measured at inclusion
|
Will be measured at inclusion
|
Will be measured at inclusion
|
Fasting blood glucose
Time Frame: Will be measured at inclusion
|
Will be measured at inclusion
|
Will be measured at inclusion
|
Total cholesterol
Time Frame: Will be measured at inclusion
|
Will be measured at inclusion
|
Will be measured at inclusion
|
LDL
Time Frame: Will be measured at inclusion
|
Will be measured at inclusion
|
Will be measured at inclusion
|
HDL
Time Frame: Will be measured at inclusion
|
Will be measured at inclusion
|
Will be measured at inclusion
|
TG
Time Frame: Will be measured at inclusion
|
Will be measured at inclusion
|
Will be measured at inclusion
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ekmekci H, Ekmekci OB. The role of adiponectin in atherosclerosis and thrombosis. Clin Appl Thromb Hemost. 2006 Apr;12(2):163-8. doi: 10.1177/107602960601200203.
- O'Brien LC, Graham ZA, Chen Q, Lesnefsky EJ, Cardozo C, Gorgey AS. Plasma adiponectin levels are correlated with body composition, metabolic profiles, and mitochondrial markers in individuals with chronic spinal cord injury. Spinal Cord. 2018 Sep;56(9):863-872. doi: 10.1038/s41393-018-0089-8. Epub 2018 Mar 20.
- Wang YH, Huang TS, Liang HW, Su TC, Chen SY, Wang TD. Fasting serum levels of adiponectin, ghrelin, and leptin in men with spinal cord injury. Arch Phys Med Rehabil. 2005 Oct;86(10):1964-8. doi: 10.1016/j.apmr.2005.04.017. Erratum In: Arch Phys Med Rehabil. 2007 May;88(5):688.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2-21-89
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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