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临床试验/NCT07402993
NCT07402993已完成不适用

DASH Diet and Cardiometabolic Risk in Parkinson's Disease: Lower Triglycerides and AIP With Higher Adherence

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Questionnaire Form

研究概览

简要总结

Participants who agreed to participate in the study were informed about the purpose of the research and obtained their consent to participate in the study using an informed consent form. The study was conducted on 70 patients with Parkinson's disease. Participants who volunteered to participate in the study were given a questionnaire form containing sociodemographic characteristics. In addition, participants' anthropometric measurements (body weight, height, waist and hip circumference, Body Mass Index (BMI)), biochemical parameters (fasting blood glucose, HbA1c, triglycerides, LDL cholesterol, triglycerides, total cholesterol, C-reactive protein (CRP), albumin, and hematology markers (hemoglobin (Hb), hematocrit (Htc), leukocytes and platelets, lymphocytes) and serum vitamin D, folic acid, vitamin B12) and nutritional status (food consumption frequency, DASH diet compliance) were obtained. New cardiovascular risk markers such as neutrophil/lymphocyte ratio (NLR), monocyte HDL ratio (MHR), and plasma atherogenic index (PAI) were calculated.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals over 19 years of age
  • Individuals who are literate
  • Individuals diagnosed with Parkinson's Disease

排除标准

  • Individuals who have had an acute infection or inflammatory disease within the past month
  • Individuals with chronic infectious or inflammatory diseases
  • Individuals with cancer

研究组 & 干预措施

Individuals with Parkinson's disease

This cohort includes adult participants diagnosed with Parkinson's disease. No control group is included.

干预措施: No intervention (observational study) (Other)

结局指标

主要结局

Questionnaire Form

时间窗: 6 months

Sociodemographic characteristics of the individuals (age, constipation status, presence of comorbidities, gender, smoking and alcohol use) were questioned.

Body weight (BW)

时间窗: 6 months

BW was measured using a calibrated digital scale placed on a flat, tiled surface. The scale was sensitive to 100 grams.

Height

时间窗: 6 months

Height was measured using a stadiometer with the participant's head positioned in the Frankfort plane and feet placed together.

Waist Circumference (WC)

时间窗: 6 months

WC was measured at the midpoint between the lowest rib and the iliac crest (cristal point) using a flexible measuring tape.

Hip Circumference (HC)

时间窗: 6 months

HC was measured at the widest point of the hips using a flexible measuring tape.

Body Mass Index (BMI)

时间窗: 6 months

BMI was calculated by dividing body weight (in kilograms) by the square of height (in meters): BMI = weight (kg) / height² (m²).

Fasting Blood Glucose

时间窗: 6 months

Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.

Triglycerides

时间窗: 6 months

Triglyceride levels were measured via fasting blood samples analyzed in the outpatient clinic laboratory.

LDL-Cholesterol

时间窗: 6 months

LDL-cholesterol was measured from fasting serum samples using standard enzymatic colorimetric methods.

HDL-Cholesterol

时间窗: 6 months

HDL-cholesterol was measured from fasting serum samples using standard enzymatic colorimetric methods.

C-Reactive Protein (CRP)

时间窗: 6 months

CRP levels were measured using routine laboratory procedures in outpatient visits.

Vitamin D

时间窗: 6 months

Serum vitamin D (25(OH)D) levels were assessed using chemiluminescence immunoassay methods in the outpatient clinic laboratory.

Folic Acid

时间窗: 6 months

Serum folic acid levels were measured using standard automated immunoassay techniques.immunoassay methods in the outpatient clinic laboratory.

Vitamin B12

时间窗: 6 months

Serum vitamin B12 concentrations were measured using automated chemiluminescent immunoassay.immunoassay methods in the outpatient clinic laboratory.

Atherogenic Index of Plasma (AIP)

时间窗: 6 months

AIP is a logarithmically transformed ratio of plasma triglycerides to high-density lipoprotein cholesterol \[log₁₀(TG/HDL-C)\], and it is used as a surrogate marker of atherogenicity and cardiovascular risk.

Monocyte-to-High-Density Lipoprotein Cholesterol Ratio

时间窗: 6 months

A biomarker reflecting the balance between inflammatory status (monocytes) and anti-atherogenic lipid components (HDL-C); it has been proposed as an indicator of systemic inflammation and cardiovascular risk.

Total Cholesterol-to-High-Density Lipoprotein Cholesterol Ratio

时间窗: 6 months

A widely used index of atherogenic risk, representing the balance between total cholesterol and protective HDL-C, with higher values indicating increased cardiovascular risk.

Neutrophil-to-Lymphocyte Ratio (NLR)

时间窗: 6 months

A systemic inflammatory marker calculated as the ratio of neutrophils to lymphocytes, commonly used to assess inflammatory status and immune response.

Food consumption frequency

时间窗: 6 months

Participants were asked about the foods they consumed in the past month from seven groups, including five basic food groups (meat and meat products, milk and dairy products, bread and grains, vegetables and fruits, sugars and fats), beverages, and fast food. Participants were asked how often and in what quantities they consumed these foods using eight options: "every meal," "every day," "5-6 days a week," "3-4 days a week," "1-2 days a week," "once every 15 days," "once a month," and "never." In evaluating food consumption records, responses regarding food consumption frequency were calculated using food consumption frequency. The amounts of food and beverages consumed were multiplied by "3" for "every meal," '1' for "every day," "0.7855" for "5-6 times a week," "0.498" for "3-4 times a week," "0.2145" for "1-2 times a week," "0.067" for "once every 15 days," and "0.033" for "once a month" to obtain the daily average amounts.

Food consumption record

时间窗: 6 months

A single-day food consumption record was obtained using the 24-hour recall method to determine participants' food consumption patterns. The Food and Nutrition Photo Catalog was used to estimate portions to ensure that the amounts of food consumed were assessed accurately and reliably. Based on these records, daily energy and nutrient intakes were calculated using the Nutrition Information System (BEBİS) software, based on the type and amount of food consumed by individuals in the last 24 hours.

DASH diet compliance

时间窗: 6 months

Individuals' DASH diet compliance scores were calculated based on their food consumption frequency after their energy requirements were calculated. The highest possible score on the DASH diet compliance scale is 8.0. A score of 4.5 or above is considered 'high compliance', while a score below 4.5 is considered 'low compliance'.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurefşan KONYALIGİL ÖZTÜRK

Assist. Prof. Dr

Abant Izzet Baysal University

研究点 (1)

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