The effect of nicotine rich diet with / without redistribution of dietary protein on motor indices in patients with Parkinson's disease

The effect of nicotine rich diet with / without redistribution of dietary protein on motor indices in patients with Parkinson's disease

Clinical trial with control group with parallel group and Randomized on 45 patients.

Sampling in this study will be done in several centers in Sari. The 45 patients will be divided into three groups by block randomization. 1) Nicotine rich diet 2) Nicotine rich diet group with redistribution of protein intake 3) Control group. The duration of the intervention is 12 weeks.

inclusion criteria: Parkinson's patients who are over 50 years old and have been diagnosed with Parkinson's disease according to the MDS clinical diagnostic criteria for Parkinson's disease; Patients receiving dopaminergic therapy who have reached a stable dose to control symptoms; Patients who have signed the consent form. Exclusion criteria: Severe systemic or psychological disease; History of gastrointestinal bleeding; Taking aspirin with a dose of more than 325 mg per day; Taking drugs that increase insulin sensitivity, heparin, warfarin, or other anticoagulants and antiplatelets; Exposure to cigarette smoke; Alcohol consumption.

1) Nicotine rich diet 2) Nicotine rich diet group with redistribution of protein intake 3) Control group

Evaluation of disease severity from the Unified Parkinson's Disease Rating Scale (UPDRS); Serum alpha-synuclein protein; Serum apolipoprotein A1; Serum cotinine

In this study, we will use block randomization. The blockage is usually used to balance the number of samples allocated to each of the studied groups. All blocks are the same size. Random allocation software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.