Ginger-PD: Ginger as a Modifier of Ghrelin Levels and Gastrointestinal Function in Parkinson's Disease - an Experimental Medicine Study
| Registry | NCT07882108, acronym Ginger-PD |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, basic science |
| Enrollment | 72 (Estimated) |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (Other); collaborators: Swansea University |
| Conditions | REM Sleep Behavior Disorder, Parkinson s Disease |
| Interventions | Ginger (Dietary supplement) |
| Dates | start 2025-12-17, primary completion 2027-03-01 (estimated), completion 2027-10-01 (estimated), first posted 2026-10-20, last updated 2026-10-21 |
| Locations | 1 site in United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for REM Sleep Behavior Disorder All trials for Parkinson s Disease All trials of Ginger
This study will test whether taking ginger supplements can increase ghrelin, a hunger hormone that is decreased in the blood of people with Parkinson's disease (PD) and REM Sleep Behaviour disorder (RBD). Three groups of participants are taking part:
1. People with Parkinson's disease (PD);
2. People with REM Sleep Behaviour Disorder (RBD);
3. Healthy people of similar age and sex.
The investigators aim to include 24 participants per group. Each participant will take ginger capsules for 12 weeks at one of two dose levels (0.24g or 0.48g of ginger root extract supplement) allocated at random.
The main goal is to find out whether ginger causes a dose-related increase in blood ghrelin levels.
Secondary goals are to explore whether ginger:
1. reduces levels of inflammation in the blood
2. improves gut symptoms including constipation
3. is well tolerabled in people with Parkinons's
If the study shows that ginger increases ghrelin levels, it will provide important early evidence to support a future larger clinical trial to determine whether ginger supplements could help slow or modify Parkinson's disease by increasing blood ghrelin levels.
Ghrelin, a hormone produced in the stomach, plays a key role in appetite, gut motility, and neuroprotection, particularly through its acylated form (AG). People with Parkinson's disease (PD) and those at high risk, such as individuals with REM Sleep Behaviour Disorder (RBD), have been found to have lower blood ghrelin levels, which may relate to gut dysfunction and faster disease progression. Preclinical studies in animal models show that ghrelin protects dopaminergic neurons, reduces inflammation, and improves motor and cognitive function, suggesting its potential as a therapeutic target in PD. However, ghrelin's short half-life and need for administration via intravenous or subcutaneous injections limits its potential as a therapeutic agent. Ginger, a safe and natural compound rich in gingerols, has been shown to raise ghrelin levels, reduce inflammation and protect neurons in experimental models. Together, these findings support testing ginger supplementation as a simple, non-invasive way to increase ghrelin levels and potentially slow disease progression in PD.
In this experimental medicine study, participants will attend up to four study visits at the John Van Geest Centre for Brain Repair, University of Cambridge with home visits provided if needed. At screening, informed consent, eligibility checks, and baseline measurements (including weight, height and medication review) will be completed, and participants will be asked to avoid all ginger-containing foods. They will receive materials for home gut function tests (whole gut transit time and methane breath test). At the baseline visit (within two weeks), participants will complete clinical and cognitive assessments (MDS-UPDRS, MoCA, semantic fluency, GIDS-PD), and blood samples will be taken before and one hour after the first ginger dose to assess the short-term ghrelin response. Participants will then take daily ginger supplements for 12 weeks.
At the end-of-intervention visit, all baseline assessments and blood sampling will be repeated. A final follow-up visit will take place four weeks after stopping the supplements to evaluate whether any effects on ghrelin levels, gut function, and inflammatory markers persist.
The ginger capsules used in this study (Lamberts) are FDA-recognized as safe (GRAS, 21CFR182.10). The supplement is well tolerated, with only rare mild gastrointestinal effects (e.g., heartburn, stomach discomfort) reported in previous studies. Participants will be asked to report any adverse events (AEs) or missed doses. Any serious adverse events (SAEs) will be reported to the Sponsor and Research Ethics Committee within 15 days if deemed related and unexpected.
Blood samples taken during study visits will be processed and stored for analysis of ghrelin levels, inflammatory markers and gut hormones. Data will be analyzed using appropriate statistical methods (e.g. repeated measures ANOVA), with a significance level of p<0.05 and correction for multiple comparisons. All data will be pseudoanonymised and stored securely in compliance with GDPR and University of Cambridge policies.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 0.24g of ginger root extract | Experimental | Dietary Supplement: Ginger | 2 capsules of ginger root extract supplement daily (1 to be taken in the morning, 1 to be taken at night) for 12 weeks |
| 0.48g of ginger root extract | Experimental | Dietary Supplement: Ginger | 4 capsules of ginger root extract supplement daily (2 to be taken in the morning, 2 to be taken at night) for 12 weeks |
Sex: All, ages: 55 Years to any, accepts healthy volunteers
People with PD * 55 years of age or above; * Meet Movement Disorder Society criteria for Idiopathic PD People with RBD * 55 years of age or above; * RBD diagnosis confirmed by polysomnography; * Prodromal PD probability score of 80% or above on the Movement Disorders Society calculator. Controls • 55 years of age or above.
| Facility | City | Country | Status |
|---|---|---|---|
| University of Cambridge | Cambridge | United Kingdom | Recruiting |