Status:
UNKNOWN
Chocolate and Physical Exercise to Reduce Malnutrition in Pre-dementia Aged People
Lead Sponsor:
Massimo Venturelli, PhD
Collaborating Sponsors:
University Of Perugia
Instituto de Investigacion Sanitaria INCLIVA
Conditions:
Dementia
Dementia, Mild
Eligibility:
All Genders
65-75 years
Phase:
NA
Brief Summary
We hypothesize that the antioxidant and cytoprotective functions of vitamin E combined with the cortisol-lowering effect of chocolate polyphenols and physical activity may help prevent the age-depende...
Detailed Description
BACKGROUND Older adults are particularly vulnerable to undernutrition, a state resulting from defective food intake or uptake (nutrient deficiencies) leading to altered body composition and weight los...
Eligibility Criteria
Inclusion
- Presence of Mild Cognitive Impairment or Mild Dementia. Recruited individuals will be assessed by means of Neuropsychological tests (Mini Mental State Examination, evaluations criteria from Diagnostic and Statistical Manual for Mental Disorder-5) which will be performed by an expert Neuropsychologist
Exclusion
- Presence of kidney or liver failure, or any other liver or kidney disease;
- Presence of gastro-intestinal disorders (i.e. irritable bowel syndrome);
- Presence of food intolerance;
- Presence of heart failure, angina, pulmonary disease, cancer and cancer-related cachexia;
- Presence of coagulation disorders;
- Addictive or previous addictive behaviour, defined as the abuse of cannabis, opioids or other drugs, carrier of infectious diseases;
- Presence of musculoskeletal diseases;
- Suffering from mental illness, inability to cooperate;
- Suffering from known cardiac conditions (e.g. pacemakers, arrhythmias, and cardiac conduction disturbances) or peripheral neuropathy;
- Regular users of any proton pump inhibitors (e.g., omeprazole, lansoprazole, pantoprazole), antibiotics, anticoagulant medication or antiplatelet medications in high dose (es: acetylsalicylic acid \>200mg x day);
- Mini Mental State (MMSE): results \>= 10 points
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT05343611
Start Date
May 1 2022
End Date
December 30 2024
Last Update
June 23 2023
Active Locations (4)
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1
CeRiSM (Sport Mountain and Health Research Center)
Rovereto, Trento, Italy, 38068
2
Clinica Pederzoli
Peschiera del Garda, Verona, Italy, 37019
3
Fondazione Mons. A. Mazzali ONLUS
Mantova, Italy, 46100
4
University of Verona
Verona, Italy, 37131