Using chocolate and exercise to improve nutrition in older adults with early dementia

Combining Vitamin E-functionalized CHOcolate With Physical Exercise to Reduce the risK Of Protein Energy Malnutrition in Pre-dementia AGEd People

This study is testing if a special dark chocolate and a high-protein diet, along with exercise, can help older adults with early dementia improve their nutrition and health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 65 Years to 75 Years
• Sex: All
• Sponsor: Universita di Verona (Academic / other)
• Locations: 4 sites (Rovereto, Trento and 3 other locations)
• Trial ID: NCT05343611 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a specially formulated dark chocolate rich in polyphenols and a high-protein diet combined with physical exercise on older adults with mild cognitive impairment or mild dementia. The trial will last for six months and will involve randomizing participants into three groups to assess the impact of these interventions on preventing malnutrition and muscle wasting. The approach aims to leverage the antioxidant properties of chocolate and the benefits of physical activity to enhance nutrient metabolism and overall health in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates for this study are older adults with mild cognitive impairment or mild dementia who are stabilized on a protein-rich diet.

Not a fit: Patients with severe kidney or liver disease, gastrointestinal disorders, or other serious health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve nutritional status and quality of life for older adults at risk of dementia and malnutrition.

How similar studies have performed: While the combination of chocolate and exercise in this context is relatively novel, previous studies have shown positive outcomes with dietary interventions and physical activity in older adults.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Rovereto, Trento and 3 other locations

• CeRiSM (Sport Mountain and Health Research Center) — Rovereto, Trento, Italy (Recruiting)
• Clinica Pederzoli — Peschiera Del Garda, Verona, Italy (Recruiting)
• Fondazione Mons. A. Mazzali ONLUS — Mantova, Italy (Recruiting)
• University of Verona — Verona, Italy (Recruiting)

Study contacts

• Principal investigator: Massimo Venturelli, PhD — Universita di Verona
• Study coordinator: Roberto Modena, PhD

Conditions Dementia; Dementia, Mild; Dementia Moderate; Dementia Senile; Malnutrition; Deficiency Nutritional; Deficiency Diseases; Frailty