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The scientific literature of recent decades demonstrates the critical role that imbalance in intestinal microbiota composition plays in triggering neuroinflammation. Simultaneously, there is clear evidence that neurodegeneration is initiated and sustained by low-grade inflammation, which is linked to cellular energy deficit. Evidence also suggests that the accumulation of misfolded proteins begins at the intestinal wall and these proteins could travel to the brain through vagus nerve fibers. Therefore, personalized nutritional interventions can constitute a non-invasive and effective strategy alongside traditional pharmacological therapies in combating neuroinflammation and neurodegeneration.
Ketogenic nutritional therapies encompass any dietary intervention that induces the production of ketone bodies (acetoacetate, beta-hydroxybutyrate, and acetone) from exogenous and/or endogenous fatty acids. In recent years, with a deeper understanding of the biochemical mechanisms underlying it, the ketogenic diet has emerged as an alternative or supportive therapeutic strategy in many neurological diseases.
A common element in diseases characterized by neurodegeneration is an alteration in the brain tissue's energy metabolism. The ketogenic diet has a favorable effect on mitochondrial function by reducing ROS levels and increasing ATP availability, slowing down disease progression or even delaying or preventing disease onset with a neuroprotective effect. The ketogenic diet increases levels of antioxidant agents, including catalase and glutathione, reduces body mass index by improving body composition through an increase in fat-free mass and a decrease in fat mass, reduces fatigue and depression, and promotes gut eubiosis through short-chain fatty acid production.
However, the high fat content of the ketogenic diet and the need to monitor carbohydrate consumption are factors that lead to reduced compliance among many patients with this dietary regimen.
The objectives are:
- Increase patient compliance with this nutritional approach through the formulation of complete nutritional foods replacements with a precise and personalized ratio of fats to protein based on individual needs and lean mass.
- Prospectively evaluate clinical outcomes (cognitive and motor performance, quality of life, and sleep quality) using specific scales before and after treatment with personalized ketogenic diet (KD).
- Prospectively evaluate changes in body composition, specifically weight trends, lean mass, and fat mass.
- Prospectively evaluate changes in intestinal microbiota before and after treatment with personalized KD.
In collaboration with the Basic Research and Product Development Medical Nutrition team at Dr. Schaer, appealing and palatable innovative products will be studied that are nutritionally complete. Patients with neuroinflammatory and neurodegenerative diseases (multiple sclerosis, epilepsy, migraine, Parkinson's disease) followed at the Neurological Clinic and Neurorhabilitation SOC (DAME) will be recruited. Patients will undergo nutritional assessment for a complete personal and nutritional history. Dietary habits will be investigated through food diaries, and patients will complete questionnaires assessing their intestinal health. Patients' fecal samples will also be collected for genetic-molecular analysis of the microbiota before nutritional initiation and at 3/6 months after starting the KD and food replacement treatment. Patients will complete a series of quality-of-life questionnaires: Fatigue Severity Scale (FSS), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Depression Anxiety Stress Scale (DASS), in addition to specific scales for each type of pathology.
Patients will start a personalized ketogenic diet tailored to address potential weight loss in cases of overweight and obesity (KD 1:1, VLCKD) or maintain weight in cases of normal weight (KD 2:1, KD 3:1, KD 4:1). Patients must adhere to the meal plan for at least 3 months and up to a maximum of 6 months. Patients will be recalled for visits at 1 month, 3 months, and for those continuing treatment, at 6 months. During each visit, patients will complete food diaries, questionnaires on intestinal function, FSS, PSQI, ESS, DASS, and disease-specific scales. Anthropometric data will be recorded at each visit, with additional genetic-molecular analysis of the microbiota performed only at the end of the dietary regimen.
Lo studio pubblicato è stato finanziato dall'Unione Europea – NextGenerationEU, Piano Nazionale di Ripresa e Resilienza (NRRP) Missione 4 Componente 2 Investimento/Subinvestimento 3.3 – Decreto Ministeriale n. 117 del 2 marzo 2023. I punti di vista e le opinioni espresse sono esclusivamente quelle degli autori e non riflettono necessariamente quelle dell'Unione Europea, né può l’Unione Europea essere ritenuta responsabile per esse.
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