The Relationship of DASH and Mediterranean Diet Score With Serum Adiponectin Levels in Patients With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

The Relationship of DASH and Mediterranean Diet Score With Serum Adiponectin Levels in Patients With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05997251
• Other study ID #: E2-21-89
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: August 2023
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Keeping a 1-day food consumption record by the patient
Checking and receiving the 1-day food consumption record recorded by the patient by the researcher
• Measurement of adiponectin level
Adiponectin level will be measured for each group

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital Physical Treatment and Rehabilitation Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adiponectin level	Adiponectin level will be measured from peripheral blood	Will be measured at inclusion
Primary	DASH diet score	Will be measured at inclusion from one day dietary record	Will be measured at inclusion from one day dietary record
Primary	Mediterrenian diet score	Will be measured at inclusion from one day dietary record	Will be measured at inclusion from one day dietary record
Secondary	Whole blood count	Will be measured at inclusion	Will be measured at inclusion
Secondary	Fasting blood glucose	Will be measured at inclusion	Will be measured at inclusion
Secondary	Total cholesterol	Will be measured at inclusion	Will be measured at inclusion
Secondary	LDL	Will be measured at inclusion	Will be measured at inclusion
Secondary	HDL	Will be measured at inclusion	Will be measured at inclusion
Secondary	TG	Will be measured at inclusion	Will be measured at inclusion