Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)

Study Overview
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Brief Summary
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A prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma.

Detailed Description
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Chronic subdural hematoma (CSDH) is one of the most common neurosurgical conditions, which is considered to be an inflammatory disease. Dietary factors can have an impact on the inflammatory mechanism in human body, which can increase a variety of inflammatory biomarkers in the blood. The risk of malnutrition in the elderly is generally high, and nutritional status can affect the risk of CSDH in the elderly. Little is known about the association of dietary factors with CSDH. The investigators speculate that dietary factors participate in and promote the occurrence and development of CSDH. This study will clarify whether there is a correlation between dietary factors and CSDH, which will reveal the pathogenesis and prevention of CSDH.

Official Title
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Association Between Dietary Factors and Chronic Subdural Hematoma: a Multicenter Case-control Study

Conditions
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Chronic Subdural Hematoma

Intervention / Treatment
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* Other: Dietary and nutritional questionnaire
* Other: Neurological function, cognitive function, and life quality assessment
* Other: Peripheral blood test
* Other: Metabonomic test
* Other: Hematoma test


Participation Criteria
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Eligibility Criteria
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Case group (CSDH group) Inclusion Criteria: Patients (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH. CSDH verified on cranial computed tomography or magnetic resonance imaging. Written informed consent from patients or their next of kin according to the patient's cognitive status. Control group (Healthy group) Inclusion Criteria: non-CSDH patients (18 years to 90 years) with matched age and gender. Written informed consent from patients or their next of kin according to the patient's cognitive status. Exclusion Criteria for both case and control group: Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before. CSDH turned from acute subdural hematoma. Existing malignant tumors, poor medication condition or severe comorbidity. Difficulty in feeding requiring long-term enteral or parenteral nutrition support. Dietary and nutritional survey is estimated to be completed difficultly. Reproductive-age women without verified negative pregnancy testing. Participating in other research.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group (CSDH group)<br>CSDH patients recruited from neurosurgical department at 4 medical centres in China, which have apparent clinical symptoms and are confirmed by computed tomography or magnetic resonance imaging. | Other: Dietary and nutritional questionnaire<br>* Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.<br>Other: Neurological function, cognitive function, and life quality assessment<br>* Neurological function, cognitive function, and life quality will be examined using Glasgow Coma Scale, Modified Rankin Scale, Markwalder Grade Scale, Mini-mental state examination, and EuroQol five dimensions questionnaire.<br>Other: Peripheral blood test<br>* Collect peripheral blood samples from patients.<br>Other: Metabonomic test<br>* Collect urine and stool samples from patients.<br>Other: Hematoma test<br>* Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.<br>|
| Control group (Healthy group)<br>non-CSDH, age- and gender-matched patients recruited from ophthalmology, otolaryngology, and physical examination department at 4 medical centres in China. | Other: Dietary and nutritional questionnaire<br>* Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.<br>Other: Peripheral blood test<br>* Collect peripheral blood samples from patients.<br>Other: Metabonomic test<br>* Collect urine and stool samples from patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in dietary intakes | Difference in dietary intakes assessed by Food Frequency Questionnaire, a common method for measuring dietary intake in large epidemiological studies. | When subjects are enrolled | 
| Difference in Dietary Inflammatory Index score | The Dietary Inflammatory Index (DII) score of the current nutritional status of patients with and without CSDH will be evaluated. The amounts of nutrients will be calculated using last 3-month nutrient analysis program. DII score will calculate from these foods. The z-score must first be calculated. To calculate the z-score, the standard global consumption amount is subtracted from the average consumption amount of the individual. The result obtained is divided by the standard deviation value. The z score found with this result is converted to the percentile score. The percentile value is multiplied by the full inflammatory effect score. DII is obtained as a result of summing the scores calculated for all nutrients. Found DII is an indicator of the inflammatory load of the individual's daily diet. | When subjects are enrolled | 
| Difference in nutritional status | Difference in nutritional status measured by Mini-Nutritional Assessment. | When subjects are enrolled | 
| Difference in frailty status | Difference in frailty status measured by Modified Frailty Index. Modified Frailty Index ranges from score 0 to 1, and frail status is defined as a score of ≥0.27. | When subjects are enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in gut microbiota measured by 16S rRNA between case group and control group | Fecal sample will be measured by 16S rRNA sequencing. The alpha and beta diversity of gut microbiota between the groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity. Based on the results of species annotation, the community histogram, the community heatmap and the Wayne map will be used to analyze the species composition of the sample, in order to explore the relationship between the species and the sample, and analyze the key microflora in the sample. The PCA, PCoA and NMDS analysis will be used to assess the similarities and differences in species composition between groups. To further screen the species with significant differences, the LEfSe difference discriminant analysis will be used. | When subjects are enrolled | 
| Difference in metabolomics of gut, urine, and serum between case group and control group | Changes of metabolites in gut, urine, and serum will be measured by metabolomic mass spectrometry. | When subjects are enrolled | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic subdural hematoma, Dietary inflammatory index, Food frequency questionnaire, Modified frailty index