Aging
Conditions
Keywords
pilot trial, accelerated aging, precision age, multimodal intervention
Brief summary
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.
Interventions
OTHERmultimodal lifestyle intervention:
* 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)
Sponsors
Heike A. Bischoff-Ferrari, Prof. Dr. med., DrPH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Community-dwelling women and men (sex) aged between 55 and 70 years * low daily exercise (i.e. \<4000 steps/day on average in the last month, self-assessment) * low fruit and vegetable intake (\< 3 per day) * at risk for accelerated functional and biological aging based on the following criteria: * overweight (BMI between 25.0 and 29.9) * at least one of the following lab values or at least borderline blood pressure within the mentioned range: * HbA1c 5.7 - 6.4% (pre-diabetes) * LDL 3.4 - 4.1 mmol L-¹ or TG \> 1.7 mmol L-¹ (atherogenesis) * hs-CRP 2 - 3 mg L-¹ (low-grade inflammation) * increase in BP or borderline BP (SBP 130 - 139 / DBP 85 - 89 mmHg) * availability of a smartphone and agrees that it can be used to connect the activity tracker to the internet and consent that data from the activity tracker will be uploaded and analyzed * Ability to communicate, read and write in German * Dietary tolerability of a Mediterranean diet (e.g. vegetables, olive oil, white meat, fish, plant-based proteins) * Ability to swallow supplement capsules
Exclusion criteria
* current smoking or vaping (smoker = More than 100 cigarettes or vapes in a life-time OR quitted less than 15 years ago and smoked more than 8 pack-years OR quitted less than 10 years ago and smoked max. 8 pack-years) * current supplementation with vitamin D and/or omega-3 and/or Fruitflow® and/or Centrum Silver® Adults 50+ multivitamin and/or taking any other multi-vitamin preparate and not willing to forgo during the trial duration * prior (ever used for more than 3 months) or current intake/application of metformin and/or GLP-1 and/or SGLT-2-inhibitor. * Current or recent (previous 12 months) participation in another clinical trial, or plans of such participation during participation in this trial * Presence of the following diagnosed health conditions in the last 4 years: * cancer (except non-melanoma skin cancer) * myocardial infarction, stroke, transient ischemic attack, angina pectoris, or coronary artery intervention * renal impairment and/or liver disease * relevant/severe impairment in mobility that leads to an inability to participate in the exercise component * major visual or hearing impairment * other serious illness that would preclude participation in the intervention components * Living together with another study participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: eligibility rate | baseline | Proportion of screened individuals who meet Inclusion/Exclusion Criteria (eligibility rate), and the most common reasons for ineligibility by criterion |
| Feasibility: recruitment rate | baseline | Recruitment rate (participants enrolled per week) and total time required to enroll n=10 |
| Feasibility: enrollment rate | baseline | Proportion of eligible individuals who provide consent and are enrolled |
| Feasibility: Retention | 14 days | Proportion of enrolled participants who complete the Day 14 visit |
| Feasibility: drop-out rate | 14 days | Proportion of enrolled participants who withdraw prior to Day 14, with reasons for withdrawal summarized |
| Feasibility: assessment completion rate | 14 days | 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 |
| Feasibility: data completeness (proportion with complete primary endpoint data at Day 14) | 14 days | 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.) |
| Feasibility: acceptability of study | 14 days | Participant-reported acceptability of study procedures by Day 14 (brief questionnaire or structured feedback) |
| Feasibility: willingness to participate in a longer trial | 14 days | Proportion of participants indicating willingness to participate in a longer (e.g., 1-year) trial using the same or similar procedures |
| Safety/tolerability: serious adverese events | 14 days | Proportion experiencing any adverse event by Day 14 |
| Safety/tolerability: related serious adverese events | 14 days | Proportion considered related to interventions |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORHeike A Bischoff-Ferrari, Prof. Dr. med., DrPH
Universitäre Altersmedizin Felix Platter
Outcome results
None listed