multimodal 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)
Study 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.
Eligibility
Sex
ALL
Min age
55 Years
Max age
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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