A Randomized Safety and Feasibility Crossover Trial of two Mediterranean-Ketogenic Interventions in Individuals with Parkinson’s Disease
Notice bibliographique
Résumé
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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,005 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,004 | 0,002 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,003 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».