Status:
RECRUITING
Maintaining Immune and Mitochondrial Functions in Old Adults With SAfe Nutrition.
Lead Sponsor:
Patrizia D'Amelio
Conditions:
Malnutrition
Sarcopenia
Eligibility:
All Genders
75+ years
Phase:
NA
Brief Summary
Aging is associated with an increased inflammation named "inflammageing" and with an altered immune response. Different mechanisms have been proposed to explain the phenomenon of inflammageing and inc...
Detailed Description
The study participants will all receive optimal standard care ensuring the optimal protein and energy intakes, with at least 1 g protein per kg body weight and day, and 30 kcal per kg body weight and ...
Eligibility Criteria
Inclusion
- Age ≥75 years
- Patients entering a rehabilitation program
- Diagnosis of malnutrition defined by a MNA-SF (mini-nutritional assessment short form) score below 11 points.
- Commitment to accept the nutritional supplement proposed, willing and able to give written informed consent
- Ability to understand and comply with the requirements of the study
Exclusion
- Presence of malignancy,
- Life expectancy of less than two months calculated by Multidimensional Prognostic Index (MPI ),
- Congestive heart failure (NYHA IV),
- Chronic renal disease (creatinine clearance \<40 ml/min calculated by cockroft),
- Liver cirrhosis (Child B-C),
- Tube/percutaneous endoscopic gastrostomy feeding or parenteral nutrition,
- Severe dysphagia,
- Mini-Mental State Examination (MMSE)≤18 and MNA\>11 points. MMSE ≥ 18 identifies patients with mild form of cognitive impairment; those patients generally do not have problems in swallowing and are able to take drugs.
- Severe anaemia (Hb\<10 g/l) or leukopenia (\<2G/l).
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05324475
Start Date
April 1 2025
End Date
March 30 2028
Last Update
May 31 2025
Active Locations (1)
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1
CHUV
Lausanne, Switzerland, Switzerland, 1012