Dietary Supplement for Parkinson's (NCT07682532)
Testing new Parkinson treatment approach
- Trial ID
- NCT07682532
- Official Title
- THE EFFECT OF L-THEANINE SUPPLEMENTATION ON REM SLEEP BEHAVIOR DISORDER, GASTROINTESTINAL FUNCTION, AND INFLAMMATORY MARKERS IN PARKINSON'S DISEASE
- Goal
- Testing new Parkinson treatment approach
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Medipol University
- Study Type
- INTERVENTIONAL
- Enrollment
- 52 participants
- Conditions
- Parkinson Disease (PD)
- Interventions
- Dietary Supplement, Control group (placebo)
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.
Locations
- Medipol Mega Hospital, Istanbul, Turkey (Türkiye)
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Dietary Supplement. 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.
- Who can participate?
- Participants must be between 50 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 5 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- 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.