Maintaining Immune and Mitochondrial Functions in Old Adults With SAfe Nutrition.
Maintaining Immune and Mitochondrial Functions in Old Adults With SAfe Nutrition: the MIMOSA Study.
Patrizia D'Amelio
240 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
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 increased oxidative stress: deficiencies in essential amino acids, and some micronutrients have an important impact and may induce immune cell dysregulation. Mitochondrial dysfunction may explain the complex relationship between malnutrition sarcopenia, immune dysfunction and aging. Therefore, a personalized nutritional strategy aiming to improve mitochondrial function, decrease oxidative stress, down-regulate inflammation and restore immunity appears to be a logical approach in order to treat malnutrition and its biological and clinical consequences. MIMOSA will investigate the role of nutritional supplements in rescuing altered mitochondrial function and redox state imbalance.
Eligibility
Inclusion Criteria5
- 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 Criteria9
- 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).
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Interventions
daily administration of oral nutritional supplements (ONS) 1) providing whole proteins together with dietary advice according with the ESPEN nutrition guidelines. All the patients will receive the standard commercially available product used at CHUV (Resource protein ®, nestle) and nutritional counselling (SC) and 4 gram per day of BCAAs mixture. Ratio between the BCAAs will be Leucine/Isoleucine/Valine=2:1:1
daily administration of oral nutritional supplements (ONS) 1) providing whole proteins together with dietary advice according with the ESPEN nutrition guidelines. All the patients will receive the standard commercially available product used at CHUV (Resource protein ®, nestle ) and nutritional counselling (SC) and Vitamin A 1200 mg RE, Vitamin D3 2000 IU, Thiamine B1 100 mg, Cobalamin B12 10 mcg, Ascorbic acid C 200 mg, Iron 30 mg, Selenium 100 mcg, Zinc 20 mg, Omega-3 PUFA 1 g
daily administration of oral nutritional supplements (ONS) 1) providing whole proteins together with dietary advice according with the ESPEN nutrition guidelines. All the patients will receive the standard commercially available product used at CHUV (Resource protein ®, nestle ) and nutritional counselling (SC) and maltodextrin 4 g as placebo
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05324475