Parkinson's Disease Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients diagnosed with Parkinson's Disease and classified as stage 1 according to the Hoehn-Yahr Staging (HYA), Patients without communication impairment (aphasia) Participants who sign the Informed Consent Form and volunteer to participate in the study Absence of dementia and Mini Mental State Examination (MMSE) score \> 24 Living in the same household with a healthy spouse/partner Not taking prebiotic, fiber, probiotic, herbal, or high-dose vitamin or mineral supplements that may affect inflammation during the pre-onset period and throughout the study protocol

Locations
Other Locations
Turkey
Medipol Mega Hospital
RECRUITING
Istanbul
Contact Information
Primary
Rüken A Samancı
rasamanci@medipol.edu.tr
+90 543 939 15 94
Time Frame
Start Date: 2026-05-02
Estimated Completion Date: 2026-10-20
Participants
Target number of participants: 52
Treatments
Experimental: L-Theanine + Mediterranean Diet
200 mg of L-theanine supplement will be given daily. A Mediterranean diet will be followed.
Placebo_comparator: Placebo + Mediterranean Diet
200 mg of placebo corn starch will be given daily. A Mediterranean diet will be followed.
Related Therapeutic Areas
Sponsors
Leads: Medipol University

This content was sourced from clinicaltrials.gov