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New treatment option for Malnutrition
Official title Maintaining Immune and Mitochondrial Functions in Old Adults With SAfe Nutrition.
ClinicalTrials.gov ID: NCT05324475
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older
You may be able to join 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 likely can't join 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,
See the full eligibility 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Switzerland, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Switzerland, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.