RecruitingNot ApplicableNCT07682532

L-THEANINE AND MEDITERRANEAN DIET ON RBD, GI FUNCTION, AND INFLAMMATION IN PARKINSON'S DISEASE

THE EFFECT OF L-THEANINE SUPPLEMENTATION ON REM SLEEP BEHAVIOR DISORDER, GASTROINTESTINAL FUNCTION, AND INFLAMMATORY MARKERS IN PARKINSON'S DISEASE


Sponsor

Medipol University

Enrollment

52 participants

Start Date

May 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Parkinson's disease is a progressive neurological disorder associated with severe dopaminergic neuron loss in the substantia nigra pars compacta. The decrease in dopamine cells in the gut in Parkinson's disease negatively affects bowel movements, and constipation is a common condition. Impairment of the intestinal barrier increases inflammation. Reactive oxygen species increase, and intestinal homeostasis changes. Alpha-synuclein levels increase in the gut. L-theanine is the most abundant amino acid in green tea leaves. Parkinson's patients exhibit increased oxidative stress along with decreased activity of glutathione peroxidase, superoxide dismutase, and catalase. L-theanine is believed to increase the activity of these enzymes and reduce oxidative stress. L-theanine administration has been found to increase total short-chain fatty acids in stool. Furthermore, it is suggested that L-theanine inhibits imbalances in oxidative stress and inflammatory responses by reducing inflammatory factors such as TNF-α, IL-6, and IL-1β. REM sleep disturbance is also a common problem in Parkinson's disease. Studies have shown that following L-theanine treatment, participants' Pittsburgh Sleep Quality Index (PSQI) scale scores improved. The gut microbiota regulates sleep and neurological states via the microbiota-gut-brain axis. L-theanine supplementation appears to be able to regulate gut bacterial composition to suppress neurotransmitters, cytokines, and other metabolites to regulate sleep. The protective effects of L-theanine administration on increased dopamine and other neurotransmitters, microbiota, sleep, and antioxidant enzymes may offer a glimmer of hope regarding its beneficial role in Parkinson's disease.


Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Control group (placebo) and Dietary Supplement for people with parkinson disease (pd). The study is currently recruiting participants at 1 location. People eligible for this study include aged 50 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTDietary Supplement

L-theanine supplementation combined with Mediterranean diet for 4 weeks.

OTHERControl group (placebo)

Placebo combined with Mediterranean diet for 4 weeks.


Locations(1)

Medipol Mega Hospital

Istanbul, Turkey (Türkiye)

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NCT07682532


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