MalnutritionMIMOSANCT05324475
Maintaining Immune and Mitochondrial Functions in Old Adults With SAfe Nutrition.
A study testing BCAA and Micronutriments in people with Malnutrition and Sarcopenia, run by Patrizia D'Amelio at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Malnutrition, Sarcopenia
- What is being tested?
- BCAA and Micronutriments
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2025to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne, Switzerland, 1012
Patrizia D'amelio, +41213143712, Patrizia.DAmelio@chuv.ch
About this study
Official title: Maintaining Immune and Mitochondrial Functions in Old Adults With SAfe Nutrition: the MIMOSA Study.
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.
Read the 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 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 ®, Nestlé) and nutritional counselling (SC).
All participants included in this study will receive daily, the oral nutritional supplement (ONS), one sachet and two capsule (for blinding purpose).
The intervention nutrients will be delivered as follows:
- BCAA: 1 sachet containing 4 g of BCAA (details in Table 1)
- Micronutrients: 1 sachet containing 4 g of the micronutrient blend and 2 capsules containing 0.6 g of OMEGA 3 PUFA (details in table 1).
The placebos will be delivered like this:
-1 sachet containing 1 g of maltodextrin and 2 capsules containing 0.6 g of coconut oil. (detailed in Table 1).
The duration of the intervention will be 6 weeks, but at least 4 weeks 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 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.
- Conditions
- Malnutrition, Sarcopenia
- Being tested
- BCAA, Micronutriments, standard treatment + placebo
- Keywords
- malnutrition, sarcopenia, immune system, Mitochondria, oxydative stress, inflammaegeing, branch-chained aminoacids, micronutrients, nutrition
- Medical subject headings
- Malnutrition, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCAADietary 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
MicronutrimentsDietary 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
standard treatment + placeboDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment (SC) | Placebo comparator | nutritional counselling (SC) + Placebo: These patients will receive Oral Nutrient Supplementation (ONS) and maltodextrin 4 g Receives: 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. Receives: Dietary Supplement: BCAA |
| Micronutrients | Experimental | In addition to the ONS the patients will receive a combination of micronutrients and PUFA Receives: Dietary Supplement: Micronutriments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mitochondrial ATP production (nmol/ml)
Production of ATP will be measured using the ATP Bioluminescent Assay Kit
Measured: 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.
Measured: 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
Measured: change vesus baseline at 30, 60 days after discharge
Secondary outcomes (7)
change micronutrients status (concentration of micronutrients)
Blood levels of Vitamins A, B12, D and E, as well as of trace elements Cu, Fe, Se, and Zn will be determined by ELISA or HPLC and ICPMS
Measured: change versus baseline at 60 days after discharge
change in inflammation
Production of pro-inflammatory cytokines involved in inflammageing and in muscle waste will be measured by ELISA technique; we will measure IL-6 and TNF-alpha (pg/ml).
Measured: change versus baseline at 30, 60 days after discharge
change phase angle (score)
Bioelectrical impedance analysis (BIA) will be carried out
Measured: change versus baseline at rehab discarge (21 days), 30, 60 days after discharge
muscle function (score)
Short performance physical battery will be used to measure muscle performance
Measured: change versus baseline at rehab discarge (21 days), 30, 60 days after discharge
muscle mass (Kg/body weight)
Bioelectrical impedance analysis (BIA) will be used to measure muscle mass
Measured: change versus baseline at rehab discarge (21 days), 30, 60 days after discharge
muscle strength (Kg)
Hand grip will be used to measure muscle strenght
Measured: change versus baseline at rehab discarge (21 days), 30, 60 days after discharge
change in perceived health status (score)
questionnaire
Measured: change versus baseline at rehab discarge (21 days), 30, 60 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Apr 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- three arms study double blind placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patrizia D'Amelio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrizia D'Amelio, Centre Hospitalier Universitaire Vaudois
- Investigators
- Patrizia D'amelio, Principal investigator, Service de gériatrie et réadaptation gériatrique-CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324475
- Sponsor's protocol ID
- MIMOSA
- Acronym
- MIMOSA
- Status last verified
- May 2025
- First submitted
- 25 Mar 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared according to the F.A.I.R. principles as follows. Findable- Accessible. All data collected will be uploaded to the Redcap research data repository after anonymization. Interoperable. The majority of the raw data produced will be in standard formats for which there is suitable open source software available. Reusable. Data publicly available will use the Creative Commons Attribution version 3.0 (http://creativecommons.org/licenses/by/3.0/) license that permits free sharing and adaptation of the licensed data with the restrictions depicted above and any related scientific publications as well as documenting any changes. Each dataset will contain appropriate citation details in the accompanying README file. 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,
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Immune and Mitochondrial Functions in Old Adults With SAfe Nutrition: the MIMOSA Study.
- ClinicalTrials.gov ID
- NCT05324475
- Acronym / sponsor ID
- MIMOSA / MIMOSA
- Conditions
- Malnutrition, Sarcopenia
- Keywords
- malnutrition, sarcopenia, immune system, Mitochondria, oxydative stress, inflammaegeing, branch-chained aminoacids, micronutrients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Patrizia D'AmelioUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 ®, Nestlé) and nutritional counselling (SC).
All participants included in this study will receive daily, the oral nutritional supplement (ONS), one sachet and two capsule (for blinding purpose).
The intervention nutrients will be delivered as follows:
- BCAA: 1 sachet containing 4 g of BCAA (details in Table 1)
- Micronutrients: 1 sachet containing 4 g of the micronutrient blend and 2 capsules containing 0.6 g of OMEGA 3 PUFA (details in table 1).
The placebos will be delivered like this:
-1 sachet containing 1 g of maltodextrin and 2 capsules containing 0.6 g of coconut oil. (detailed in Table 1).
The duration of the intervention will be 6 weeks, but at least 4 weeks 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- three arms study double blind placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Standard treatment (SC) | Placebo comparator | Dietary Supplement: standard treatment + placebonutritional counselling (SC) + Placebo: These patients will receive Oral Nutrient Supplementation (ONS) and maltodextrin 4 g |
| Branch-chained aminoacids | Experimental | Dietary Supplement: BCAAIn 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. |
| Micronutrients | Experimental | Dietary Supplement: MicronutrimentsIn addition to the ONS the patients will receive a combination of micronutrients and PUFA |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCAAdaily 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 | Dietary supplement | Branch-chained aminoacids |
| Micronutrimentsdaily 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 | Dietary supplement | Micronutrients |
| standard treatment + placebodaily 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 | Dietary supplement | Standard treatment (SC) |
Primary outcome
Change in mitochondrial ATP production (nmol/ml)
Time frame: change vesus baseline at 30, 60 days after discharge
Production of ATP will be measured using the ATP Bioluminescent Assay Kit
Change in redox state (plasmatic concentration of metabolites)
Time frame: change vesus baseline at 30, 60 days after discharge
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 in mitochondrial electron flux (nmol cit/min/mg prot)
Time frame: change vesus baseline at 30, 60 days after discharge
The activity of Complex I and III will be measured on non-sonicated mitochondrial samples
7 secondary outcomes
change micronutrients status (concentration of micronutrients)
Time frame: change versus baseline at 60 days after discharge
change in inflammation
Time frame: change versus baseline at 30, 60 days after discharge
change phase angle (score)
Time frame: change versus baseline at rehab discarge (21 days), 30, 60 days after discharge
muscle function (score)
Time frame: change versus baseline at rehab discarge (21 days), 30, 60 days after discharge
muscle mass (Kg/body weight)
Time frame: change versus baseline at rehab discarge (21 days), 30, 60 days after discharge
muscle strength (Kg)
Time frame: change versus baseline at rehab discarge (21 days), 30, 60 days after discharge
change in perceived health status (score)
Time frame: change versus baseline at rehab discarge (21 days), 30, 60 days after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Yes. The data will be shared according to the F.A.I.R. principles as follows. Findable- Accessible. All data collected will be uploaded to the Redcap research data repository after anonymization. Interoperable. The majority of the raw data produced will be in standard formats for which there is suitable open source software available. Reusable. Data publicly available will use the Creative Commons Attribution version 3.0 (http://creativecommons.org/licenses/by/3.0/) license that permits free sharing and adaptation of the licensed data with the restrictions depicted above and any related scientific publications as well as documenting any changes. Each dataset will contain appropriate citation details in the accompanying README file. 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,
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrizia D'amelio principal investigator
Service de gériatrie et réadaptation gériatrique-CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCAA and Micronutriments in people with Malnutrition and Sarcopenia, run by Patrizia D'Amelio at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrizia D'amelio (+41213143712, patrizia.damelio@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mitochondrial ATP production (nmol/ml) (time frame: change vesus baseline at 30, 60 days after discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.