Evaluation the effect of saffron supplementation on some indices of inflammation and oxidative stress, stage of disease, motor and non-motor symptoms, mental health, cognitive impairment, intestinal permeability, gastrointestinal symptoms, appetite, fatigue, quality of life, and sleep quality in patients with Parkinson's disease: A triple blind randomized controlled clinical trial

Evaluation the effect of saffron supplementation on some indices of inflammation and oxidative stress, stage of disease, motor and non-motor symptoms, mental health, cognitive impairment, intestinal permeability, gastrointestinal symptoms, appetite, fatigue, quality of life, and sleep quality in patients with Parkinson's disease

A controlled, randomized, triple-blind clinical trial with parallel groups, phase 3 on 92 patients with Parkinson's disease. Randomization based on the permuted blocks randomization according to sex and stage of disease

The participants will be selected from patients with Parkinson's disease who refer to the neurologist's clinic in Isfahan city. All patients will be asked to return any unused tablets at each visit. At the beginning and end of the study, all outcomes will be measured and recorded.

Inclusion criteria: Age of 45 years old or more; Diagnosis of Parkinson's disease based on United Kingdom PD Society Brain Bank (UKPDSBB)criteria; Having the Hoehn and Yahr score less than 5; BMI equal or less than 40; Non-inclusion criteria: Adherence to a specific diet or consumption of saffron supplement in the last 3 months; Patients with other neurodegenerative diseases such as Huntington's disease, Wilson's disease; Central nervous system infections such as meningitis; having a Hoehn and Yahr score of 5 out of 5; Patients with a history of saffron allergy;

Intervention: 100 mg/day Saffron supplementation for 12 weeks; Control: 100 mg/day lactose powder supplementation for 12 weeks.

indices of inflammation and oxidative stress, stage of disease, motor and non-motor symptoms, mental health, cognitive impairment, intestinal permeability, gastrointestinal symptoms, appetite, fatigue, quality of life, and sleep quality

increasing the sample size due to possible dropout and correction of omitted items

Randomization of patients will be done using a four-block randomization method. For this purpose, people will be classified into 4 states based on the variables of gender and stage of the disease and people with the same states will be randomly assigned to intervention and placebo groups in a 1:1 ratio. Block randomization will be done using a list of random numbers generated by the website https://www.sealedenvelope.com/simple and by an independent researcher.

This study is a triple blind clinical trial. The saffron supplement and its placebo will be packed identically in terms of (color, shape and smell) in similar boxes. In order to carry out this research in a triple blind manner, patients, researchers who are responsible for interview, sampling and evaluating tests and statistical analyzes will be blinded.