---
title: Testing new Parkinson treatment approach
nct_id: NCT07682532
phase: NA
status: RECRUITING
sponsor: Medipol University
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07682532"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07682532"
last_fetched: "2026-07-06T14:01:15.271Z"
source: "Parkinson's Pathways (curated)"
---
# Testing new Parkinson treatment approach

**Goal (in five words):** Testing new Parkinson treatment approach

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

**Trial ID:** [NCT07682532](https://clinicaltrials.gov/study/NCT07682532)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Medipol University
- **Target Enrollment:** 52 participants
- **Start Date:** 2026-05-02
- **Completion Date:** 2026-09-25
- **Conditions:** Parkinson Disease (PD)
- **Interventions:** Dietary Supplement, Control group (placebo)
- **Intervention Types:** DIETARY_SUPPLEMENT, OTHER

## Summary For Families

Researchers are testing whether L-theanine, an amino acid found in green tea, can help common Parkinson's problems such as constipation, REM sleep disturbance, and gut inflammation by reducing cell damage from unstable oxygen molecules and calming inflammatory responses. The approach is a dietary supplement versus placebo, and prior work suggests L-theanine can increase antioxidant enzyme activity, raise helpful short-chain fats in stool, lower inflammatory molecules like TNF-alpha, and improve sleep quality. The study seeks people aged 50 to 80 with early-stage Parkinson's (stage 1), no dementia (cognitive score above 24), who live with a healthy partner and are not using probiotics, high-dose supplements, recent antibiotics, heavy caffeine, tobacco, or alcohol, along with other health exclusions.

## What This Actually Involves

**Placebo** _(From the protocol)_: This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.

**Visits** _(Ask the coordinator)_: Ask the coordinator how many in-person visits the study involves, how long each one takes, and over what total period.

**Procedures** _(Ask the coordinator)_: Ask the coordinator what tests and procedures are involved, for example blood draws, scans, or questionnaires, and whether any are uncomfortable or invasive.

**Washout** _(Ask the coordinator)_: Ask the coordinator whether you would need to stop or pause any of your current medications before or during the study (a washout period), and for how long.

**Travel & reimbursement** _(Ask the coordinator)_: Ask the coordinator whether travel, parking, or your time is reimbursed or compensated, and what is covered.

_Fields marked “From the protocol” come from the trial's registry record or quoted protocol text. Fields marked “Ask the coordinator” are not reliably available and should be confirmed directly._

## Eligibility

- **Minimum age:** 50 Years
- **Maximum age:** 80 Years
- **Sex:** ALL

### Full Criteria

```
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)
```

## Locations (1)

- Medipol Mega Hospital, Istanbul, Turkey (Türkiye) _(41.0138, 28.9497)_
  - Rüken A Samancı, (CONTACT), +90 543 939 15 94, rasamanci@medipol.edu.tr
  - Gözde Ülfer, (PRINCIPAL_INVESTIGATOR)
  - Eren Toplutaş, (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- Rüken A Samancı, (CONTACT), +90 543 939 15 94, rasamanci@medipol.edu.tr

---

*Canonical: https://parkinsonspathways.com/trial/NCT07682532*  
*HTML version: https://parkinsonspathways.com/trial/NCT07682532*  
*Source data: https://clinicaltrials.gov/study/NCT07682532*