A Randomized Safety and Feasibility Crossover Trial of two Mediterranean-Ketogenic Interventions in Individuals with Parkinson’s Disease
Bibliographic record
Abstract
ABSTRACT BACKGROUND Both Mediterranean and ketogenic diets have been proposed as nutritional interventions in Parkinson’s disease (PD). Combined approaches may offer maximal benefits. OBJECTIVE Assess the feasibility, safety and exploratory efficacy of two Mediterranean-ketogenic dietary interventions in individuals with PD (PwP). METHODS In this Phase II, random-order crossover study, PwP followed two 8-week dietary interventions, separated by an 8-week washout: 1) a high-fat, low-carbohydrate Mediterranean diet (MeDi-KD) and 2) a standard Mediterranean diet supplemented with medium chain triglycerides (MeDi-MCT). RESULTS Of 52 participants randomized, 48 started the trial. Forty-one (79%) participants completed at least one and 33 (63%) completed both intervention phases. There were no intervention-related serious adverse events, nor any significant changes in plasma lipid profiles. Seventy-three percent and 92% of participants reported deviating from the MeDi-KD and MeDi-MCT no more than a few times per month, respectively. Moderate Mediterranean Diet Adherence Scores of 6.7 (SD: 1.6) and 7.2 (SD: 2.3) were achieved during the MeDi-KD and MeDi-MCT, respectively, out of a maximum of 14. Fifty percent of participants were in nutritional ketosis (BHB >0.5 mM) at follow-up for the MeDi-KD, as compared with only 1 (3%) participant following the MeDi-MCT. MDS-UPDRS Part II and IV scores decreased by a mean of -1.4 (SD: 4.2; p=0.039) and -1.0 (SD: 3.0; p=0.044) points, respectively, following the MeDi-MCT. CONCLUSIONS Mediterranean-ketogenic interventions appear safe and potentially beneficial in PwP. Behavioral strategies to optimize adherence should be employed in future phase III trials. TRIAL REGISTRATION The trial was registered on ClinicalTrials.gov: NCT05469997 . PLAIN LANGUAGE SUMMARY Many patients want to know what the best diet is to follow for their Parkinson’s disease. Previous studies have suggested benefits of both ketogenic diets, which are high in fats and low in carbohydrates, and Mediterranean-style diets. Combining these two approaches could offer maximal advantages, while reducing the challenges of following a strict ketogenic diet. The aim of this study was to test whether so-called “Mediterranean-ketogenic” diets would be safe and practical for patients with Parkinson’s disease to follow. Early indicators of potential clinical benefit were also assessed. Fifty-two participants were randomly assigned to follow two types of Mediterranean-ketogenic diets for eight weeks each, with an eight-week break in between. The two interventions were: 1) A high-fat, low carbohydrate version of a Mediterranean diet (MeDi-KD) and 2) A Mediterranean diet administered with a ketogenic supplement, medium-chain triglyceride oil (MeDi-MCT). Forty-eight people started the study, 41 completed at least one diet intervention phase and 33 completed both intervention phases. No serious side effects were reported. Although most participants felt they followed the diets closely, objective measures of adherence suggested room for improvement. The MeDi-MCT diet led to small but significant improvements in patient-reported motor activities of daily living and motor complications. Longer-term studies are needed to validate these findings. Future trials should incorporate behavioral coaching techniques to better help participants follow the diets.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.005 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".