NCT05324475 Maintaining Immune and Mitochondrial Functions in Old Adults With SAfe Nutrition.
| NCT ID | NCT05324475 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Patrizia D'Amelio |
| Condition | Malnutrition |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2025-04-01 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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).
Contact & Investigator
Patrizia D'amelio
PRINCIPAL INVESTIGATOR
Service de gériatrie et réadaptation gériatrique-CHUV
Frequently Asked Questions
Who can join the NCT05324475 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Malnutrition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05324475 currently recruiting?
Yes, NCT05324475 is actively recruiting participants. Contact the research team at patrizia.damelio@chuv.ch for enrollment information.
Where is the NCT05324475 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT05324475 clinical trial?
NCT05324475 is sponsored by Patrizia D'Amelio. The principal investigator is Patrizia D'amelio at Service de gériatrie et réadaptation gériatrique-CHUV. The trial plans to enroll 240 participants.