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

NCT05324475 | Recruiting DMC

• 1 other identifier: MIMOSA
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition; Sarcopenia

Keywords

malnutrition; sarcopenia; immune system; Mitochondria; oxydative stress; inflammaegeing; branch-chained aminoacids; micronutrients; nutrition

Outcome Measures

Primary Outcomes (3)

• Change in mitochondrial ATP production (nmol/ml)

  Production of ATP will be measured using the ATP Bioluminescent Assay Kit

  change vesus baseline at 30, 60 days after discharge

• Change in redox state (plasmatic concentration of metabolites)

  analyses of thiometabolome contains: methionine, methionine sulfone, methionine sulfoxide, cysteine, homocysteine, homocystine, cystathionine, formylmethionine, cystine, glutathione, glutathione disulfide, taurine, S-adenosylmethionine, S-adenosylhomocysteine, N-acetylcysteine, cysteic acid, serine, glycine, glutamic acid, lypoic acid, selenocysteine, thioctic acid, pyruvic acid.

  change vesus baseline at 30, 60 days after discharge

• Change in mitochondrial electron flux (nmol cit/min/mg prot)

  The activity of Complex I and III will be measured on non-sonicated mitochondrial samples

  change vesus baseline at 30, 60 days after discharge

Secondary Outcomes (7)

• change micronutrients status (concentration of micronutrients)

  change versus baseline at 60 days after discharge

• change in inflammation

  change versus baseline at 30, 60 days after discharge

• change phase angle (score)

  change versus baseline at rehab discarge (21 days), 30, 60 days after discharge

• muscle function (score)

  change versus baseline at rehab discarge (21 days), 30, 60 days after discharge

• muscle mass (Kg/body weight)

  change versus baseline at rehab discarge (21 days), 30, 60 days after discharge

Study Arms (3)

Standard treatment (SC)

PLACEBO COMPARATOR

nutritional counselling (SC) + Placebo: These patients will receive Oral Nutrient Supplementation (ONS) and maltodextrin 4 g

Dietary Supplement: standard treatment + placebo

Branch-chained aminoacids

EXPERIMENTAL

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.

Dietary Supplement: BCAA

Micronutrients

EXPERIMENTAL

In addition to the ONS the patients will receive a combination of micronutrients and PUFA

Dietary Supplement: Micronutriments

Interventions

BCAA DIETARY_SUPPLEMENT

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

Branch-chained aminoacids

Micronutriments DIETARY_SUPPLEMENT

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

Micronutrients

standard treatment + placebo DIETARY_SUPPLEMENT

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

Standard treatment (SC)

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Patrizia D'Amelio: lead

Study Sites (1)

CHUV

Lausanne, Switzerland, 1012, Switzerland

RECRUITING

MeSH Terms

Conditions

Malnutrition; Sarcopenia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Patrizia D'amelio

  Service de gériatrie et réadaptation gériatrique-CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrizia D'amelio

CONTACT

+41213143712; patrizia.damelio@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention nutrients will be delivered as powder in sachets identified as B (BCAA, 4 gr) or C (mixture of micronutrients, 4 gr), placebo sachets identified as A will contain maltodextrin, (4 gr); the sachets will be mixed by the patients in a juice. Blinding will be maintained until interim evaluation and after for the full trial. In order to assure the blinding the sachets will be opaque identified by a single letter ready to be mixture with a juice with similar taste and texture between the different formulations
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associated professor

Model Details: three arms study double blind placebo controlled

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 12, 2022
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: We will make data open immediately if not sensitive for IP protection. Data with sensitive IP will be made available after 5 years from the end of the project
• Access Criteria: upon reasonable request to the PI

Locations

CH (1)