This is a pilot trial to test the feasibility of a multimodal lifestyle intervention (physical activity, mindfulness, sleep routines, calorie-restricted Mediterranean diet, supplements: vitamin D, omega-3, Multivitamin-mineral Centrum50+®, plant-based-supplement Fruitflow®) in preparation of a larger clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
10
* personalized physical activity program including strength, endurance, and mindfulness components plus instruction to reduce sedentary behavior and improve sleep; * personalized Mediterranean, calorie-reduced diet recommendation; * intake of nutritional supplements: 2'000 IU/d of vitamin D (incl. multivitamin), 1g/d of omega-3 fatty acids, Centrum Silver® Adults 50+ 1 tbl/d, Fruitflow® 150 mg/d (plant-based extract from tomatoes)
Universitäre Altersmedizin Felix Platter
Basel, Canton of Basel-City, Switzerland
Feasibility: eligibility rate
Proportion of screened individuals who meet Inclusion/Exclusion Criteria (eligibility rate), and the most common reasons for ineligibility by criterion
Time frame: baseline
Feasibility: recruitment rate
Recruitment rate (participants enrolled per week) and total time required to enroll n=10
Time frame: baseline
Feasibility: enrollment rate
Proportion of eligible individuals who provide consent and are enrolled
Time frame: baseline
Feasibility: Retention
Proportion of enrolled participants who complete the Day 14 visit
Time frame: 14 days
Feasibility: drop-out rate
Proportion of enrolled participants who withdraw prior to Day 14, with reasons for withdrawal summarized
Time frame: 14 days
Feasibility: assessment completion rate
Completion rate for each major assessment at Baseline and Day 14 (6-minute Walk Test (6MWT), knee extensor muscle strength measurements, Cambridge Neuropsychological Test Automated Battery (CANTAB®)), including the proportion with valid/usable results
Time frame: 14 days
Feasibility: data completeness (proportion with complete primary endpoint data at Day 14)
Data completeness for the overall assessment battery at Day 14 (proportion with complete primary endpoint data at Day 14), with documentation of missingness reasons (participant burden, scheduling, technical failure, etc.)
Time frame: 14 days
Heike A Bischoff-Ferrari, Prof. Dr. med., DrPH
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Feasibility: acceptability of study
Participant-reported acceptability of study procedures by Day 14 (brief questionnaire or structured feedback)
Time frame: 14 days
Feasibility: willingness to participate in a longer trial
Proportion of participants indicating willingness to participate in a longer (e.g., 1-year) trial using the same or similar procedures
Time frame: 14 days
Safety/tolerability: serious adverese events
Proportion experiencing any adverse event by Day 14
Time frame: 14 days
Safety/tolerability: related serious adverese events
Proportion considered related to interventions
Time frame: 14 days