Maintaining Immune and Mitochondrial Functions in Old Adults With SAfe Nutrition. — MIMOSA  

Sarcopenia Clinical Trial

Official title: Maintaining Immune and Mitochondrial Functions in Old Adults With SAfe Nutrition: the MIMOSA Study.

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 day (or the measured energy expenditure (EE) value). This will be realized by the daily administration of oral nutritional supplements (ONS) 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).

• SC-Placebo: These patients will receive ONS and maltodextrin 4 g

• BCAAs: In addition to the ONS these patients will receive 4 gram per day of BCAAs mixture. Ratio between the BCAAs will be Leucine/Isoleucine/Valine=2:1:1, as delivered in our previous study.

• Micronutrient complements (Micro). In addition to the ONS the patients will receive a combination of micronutrients.

After enrollment patients will be subjected to evaluation of muscle mass by bioimpedance (BIA), muscle strength will be by handgrip strength and muscle performance by the Short Performance Physical Battery (SPPB).

Nutritional status will be evaluated by the Mini Nutritional Assessment short form (MNA-SF), Nutrition Risk screening (NRS) score and Body mass index (BMI). Energy expenditure (EE) will be measured by indirect calorimetry using a canopy.

Moreover appropriate experiments will be carried out in order to evaluate mitochondrial bioenergetics, replication, and fusion, as well as of redox state.

Analyses of inflammageing and immune-senescence will be will be done by appropriate lab experiments.

Micronutrient status will be measured by ELISA or HPLC and ICPMS respectively. Patients will be evaluated at inclusion, at rehabilitation discharge, and one and two months after rehabilitation discharge. The volume of blood required for the above investigations will be 3 x 30 ml over the 2-month period. ;

Related Conditions & MeSH terms

• Malnutrition
• Sarcopenia

• NCT number: NCT05324475
• Study type: Interventional
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Patrizia D'amelio
• Phone: +41213143712
• Email: patrizia.damelio@chuv.ch
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Completion date: December 31, 2026