NCT07402993

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 5, 2026

Last Update Submit

February 10, 2026

Conditions

Keywords

Cardiovascular riskDASH dietParkinson's disease

Outcome Measures

Primary Outcomes (21)

  • Questionnaire Form

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

    6 months

  • Body weight (BW)

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

    6 months

  • Height

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

    6 months

  • Waist Circumference (WC)

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

    6 months

  • Hip Circumference (HC)

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

    6 months

  • Body Mass Index (BMI)

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

    6 months

  • Fasting Blood Glucose

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

    6 months

  • Triglycerides

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

    6 months

  • LDL-Cholesterol

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

    6 months

  • HDL-Cholesterol

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

    6 months

  • C-Reactive Protein (CRP)

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

    6 months

  • Vitamin D

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

    6 months

  • Folic Acid

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

    6 months

  • Vitamin B12

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

    6 months

  • Atherogenic Index of Plasma (AIP)

    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.

    6 months

  • Monocyte-to-High-Density Lipoprotein Cholesterol Ratio

    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.

    6 months

  • Total Cholesterol-to-High-Density Lipoprotein Cholesterol Ratio

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

    6 months

  • Neutrophil-to-Lymphocyte Ratio (NLR)

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

    6 months

  • Food consumption frequency

    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.

    6 months

  • Food consumption record

    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.

    6 months

  • DASH diet compliance

    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'.

    6 months

Study Arms (1)

Individuals with Parkinson's disease

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

Other: No intervention (observational study)

Interventions

No intervention (observational study)

Individuals with Parkinson's disease

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study was designed as a cross-sectional descriptive study. The study included patients who presented to the Neurology Outpatient Clinic at BAİBÜ İzzet Baysal Education and Research Hospital and diagnosed with Parkinson's Disease

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University, Faculty of Health Sciences

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Nurefşan Konyalıgil Öztürk

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 11, 2026

Study Start

June 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations