Healthy senior volunteers Not Applicable
Conditions
Interventions
The randomization will be performed by a statistician who will have no contact with the participants. The research team and participants will be unaware of the group assignments and the envelop with a
Sponsors
Horphag Research (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Volunteers aged between 65 and 80 years 2. Volunteers with a body mass index (BMI) of less than 35 kg/m² 3. Volunteers leading a sedentary lifestyle, without symptoms of depression, and with typical dietary habits 4. Volunteers willing to undergo testing for body composition, physical strength, and endurance 5. Volunteers willing to take Robuvit® or placebo daily and provide blood samples 6. Volunteers who are willing to sign an informed consent form
Exclusion criteria
Exclusion criteria: 1. Aged 80 years old 2. Body mass index (BMI) greater than 35 kg/m² 3. Acute myocardial infarction (MI) or shortly after MI 4. Chronic inflammatory diseases (e.g., rheumatoid arthritis) 5. Unable or unwilling to sign the informed consent form 6. Unable or unwilling to provide biological samples as needed 7. Neurodegenerative and cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias), with acute or terminal illnesses including current (treated or untreated) oncological diseases, and those with type 1 or type 2 diabetes mellitus 8. Have undergone surgery/completed chemotherapy/radiotherapy within the last 12 months 9. A history of recent fractures with functional impairment; inability to commit to the study and its requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Muscle strength measured using isokinetic dynamometry (Biodex System) at baseline, week 6, and week 18. The specific variables assessed will include peak torque and maximum flexion moment of the hamstrings, and peak torque and maximum extension moment of the quadriceps, along with handgrip strength (using a dynamometer). 2. Physical endurance measured using a submaximal standardized aerobic exercise test on a cycle ergometer (direct measurement of oxygen consumption, VO2 max) at baseline, week 6, and week 18 3. Body composition (muscle and fat mass) measured using bioelectrical impedance (InBody 720) at baseline, week 6, and week 18, alongside anthropometric parameters (height, weight, waist, and hip circumference) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be assessed at baseline, week 6, and week 18: 1. Resting metabolic rate measured using indirect calorimetry 2. Muscle growth and protein synthesis regulators (myostatin, IGF-1, P3NP, BDNF) measured using serum assays 3. Markers of inflammation (Nrf2, IL-1ß, IL-6, TNFa) measured using qRT-PCR (RNA isolated from blood samples) 4. Serum urolithins measured using liquid chromatography-mass spectrometry (LC-MS) for verification of Robuvit intake 5. Creatinine, urea, testosterone, glucose, and growth hormone (GH) levels measured using standard blood assays 6. Mitochondrial respiration measured using an O2k-Respirometer (Oroboros Instruments, Austria), respiratory function of liver mitochondria measured at 30°C using an amperometric measurement of oxygen consumption on an oxygraph Gilson 5/6 H (USA) equipped with a Clark-type oxygen electrode, and CoQ levels measured using a high-performance liquid chromatography (HPLC) method with spectrophotometric detection | — |
Countries
Slovakia
Contacts
Public ContactJana Muchová
Outcome results
None listed