L-theanine and the Mediterranean diet for sleep, gut health, and inflammation in Parkinson’s disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares L-theanine with a placebo, alongside a Mediterranean-style dietary plan, in people with Parkinson’s disease at Hoehn-Yahr stage 1. The trial aims to see if the combination can improve REM sleep behavior disorder symptoms, bowel function, and inflammation, potentially via effects on gut microbiota and oxidative stress. Participants will be adults with Parkinson’s disease who meet inclusion criteria and do not have major comorbidities, and will be followed for a defined period with periodic assessments. Outcomes likely include sleep behavior, GI function, and laboratory inflammation markers, with safety monitoring for any adverse effects. The study is conducted at Medipol Mega Hospital in Istanbul under the lead sponsor Medipol University.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

Patients with a history of severe heart, lung, liver, or kidney failure, primary psychiatric, developmental, or other neurological disease Patients using sedative/hypnotic medications Individuals consuming more than 200 mg of caffeine per day (approximately 2-3 cups of tea or 1 cup of coffee) Patients who smoke and consume alcohol Having undergone surgery related to bowel health Having a chronic infectious bowel disease Having a congenital bowel anomaly Using probiotics, antifungals, and/or antibiotics within the last three months Individuals with an autoimmune disease or weakened immune system Self-reported alcohol or drug use within the last 3 months Current use of over-the-counter medications, supplements, foods, and/or beverages that may affect stress, sleep, cognition, and/or mood Inability to swallow the study supplement due to swallowing anxiety Receiving treatment for a GI disease or condition diagnosed by a doctor other than constipation, gastroparesis, gastroesophageal reflux disease, or diverticular disease Positive results for human immunodeficiency virus (HIV) or Hepatitis B/C. Current history of active conditions of inflammatory bowel disease, irritable bowel syndrome, colitis, celiac disease, short bowel syndrome, colostomy, colectomy, gastrointestinal fistula, or strictures.

Recent or current use of any antibiotic (within 4 weeks prior to the start of the study) Use of enemas or suppositories to relieve constipation Good adherence to the Mediterranean diet in the pre-start period according to the 14-item Mediterranean Diet Assessment Tool (score \>6)

Where it's running

• Medipol Mega Hospital
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Rüken A Samancı
• Email: rasamanci@medipol.edu.tr
• Phone: +90 543 939 15 94

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.