An interventional study of Ginger in REM Sleep Behavior Disorder and Parkinson s Disease, sponsored by Cambridge University Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Basic science
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:
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:
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.
98 studies on the registry are indexed under REM Sleep Behavior Disorder; 42 are open to participants now.
This study's planned enrollment of 72 is above the median of 47 across 50 interventional studies indexed under REM Sleep Behavior Disorder.
Browse REM Sleep Behavior Disorder studies →Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 170 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
People with PD
People with RBD
Controls
2 capsules of ginger root extract supplement daily (1 to be taken in the morning, 1 to be taken at night) for 12 weeks
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
Dietary Supplement: Ginger
The specific ginger supplement used in this study (Ginger Capsules, Lamberts©) is generally recognized as safe (GRAS) by the Food \& Drug Administration (FDA, 21CFR182.10). The capsule ingredients are as follows: modified starch, glycerol, carrageenan, ieon oxide, sodium carbonate, sunflower seed oil, ginger root extract, silicoa dioxide
Change in fasting blood acylated and unacylated ghrelin levels in PD, RBD and controls over 12 weeks of ginger supplementation.
Time frame: Baseline - 12 weeks
Tolerability - compliance measured by self-recorded supplement diary and capsule counts.
Time frame: Baseline - 12 weeks
Change in fasting blood acylated and unacylated ghrelin levels in PD, RBD and controls at 16 weeks (4 weeks post cessation of ginger supplements)
Time frame: Baseline - 16 weeks
Change in levels of blood inflammatory markers (TNF-α, IL-6, IL-17, IL-1β, CRP, IFN-γ, neutrophil:lymphocyte ratio, systemic inflammatory index)
Time frame: Baseline - 12 weeks, 16 weeks
Change in blood levels of gut enzymes/hormones (including but not limited to Ghrelin-O-Acyltransferase, IGF-1, GLP-1).
Time frame: Baseline - 12 weeks, 16 weeks
Change in objective measures of gut function including whole gut transit time and methane breath tests.
Time frame: Baseline - 12 weeks
Change in self-reported gut symptoms assessed using the Gastrointestinal Dysfunction in PD scale (GIDS-PD)
Time frame: Baseline - 12 weeks, 16 weeks
Change in MDS-UPDRS parts I, II, III, IV (PD and RBD participants only).
Time frame: Baseline - 12 weeks
Change in MoCA score
Time frame: Baseline - 12 weeks
Change in semantic fluency score
Time frame: Baseline - 12 weeks
Plan to share: Undecided
Started Dec 2025 (actual). Primary completion is estimated for Mar 2027, 14 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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