RecruitingNot ApplicableNCT07523061

PrecisionAge Pilot Study


Sponsor

Heike A. Bischoff-Ferrari, Prof. Dr. med., DrPH

Enrollment

10 participants

Start Date

Apr 10, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 55 YearsMax Age: 70 Years

Inclusion Criteria14

  • 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 Criteria12

  • 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

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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)


Locations(1)

Universitäre Altersmedizin Felix Platter

Basel, Canton of Basel-City, Switzerland

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NCT07523061


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