PrecisionAge Pilot Study

PrecisionAge Pilot Study

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.

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