Clinical Trial of a Low Protein Diet in Patients With Cognitive Impairment
Mild Cognitive Impairment, Mild Dementia, Fasting-Mimicking Diet
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Fasting-Mimicking Diet, nutritional status, MCI, Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- Age 55-80;
- Presence of aMCI or initial AD (MMSE 18-23);
- Normal organ function (liver and kidney);
- BMI not less than 20 kg/m2;
- Bioimpedance phase angle (PA) > 5 °;
- Adherence to informed consent
Exclusion Criteria:
- Age> 80 years
- Diabetes mellitus;
- Organ impairment (liver, kidney);
- Food allergies to the components of ProlonADTM;
- Patients on therapy with vitamin K antagonist anticoagulants;
- PA <5 °;
- Patients who live alone or are not adequately supported by the family context;
- Other experimental therapies in progress.
Sites / Locations
- Alessio NencioniRecruiting
- Ospedale Policlinico San MartinoRecruiting
- Azienda Ospedaliera di PerugiaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
ProlonADTM
Placebo diet
The ProlonADTM diet, which will be taken by the patient once a month for 5 days, is a low-calorie and low-protein diet, and provides all the micronutrients necessary to avoid malnutrition. The diet will be performed in twelve consecutive months. The components of the diet will be approximately 30% calorie restricted and 50% protein restricted but supplemented with 50% of the RDA in vitamins and minerals and also supplemented with both nonessential and essential amino acids identified in animal studies to be effective. Prolon by L-Nutra is a medically-designed dietary kit providing the food to eat for five days. Day 1 of Prolon provides ~4600 kJ (11% protein, 46% fat, and 43%carbohydrate), whereas days 2-to-5 provide ~3000 kJ (9% protein, 44% fat, and 47% carbohydrate) per day.
One meal which substitute or lunch or dinner for 5 days, without calories restriction.