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OpenTrials
Active, Not Recruiting

NCT Number: NCT07523061

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aging

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitäre Altersmedizin Felix Platter

Basel, Canton of Basel-City, 4055, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multimodal lifestyle intervention:

Other
  • 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)

Primary outcomes

  1. Feasibility: eligibility rate

    Time frame: baseline

    Proportion of screened individuals who meet Inclusion/Exclusion Criteria (eligibility rate), and the most common reasons for ineligibility by criterion

  2. Feasibility: recruitment rate

    Time frame: baseline

    Recruitment rate (participants enrolled per week) and total time required to enroll n=10

  3. Feasibility: enrollment rate

    Time frame: baseline

    Proportion of eligible individuals who provide consent and are enrolled

  4. Feasibility: Retention

    Time frame: 14 days

    Proportion of enrolled participants who complete the Day 14 visit

  5. Feasibility: drop-out rate

    Time frame: 14 days

    Proportion of enrolled participants who withdraw prior to Day 14, with reasons for withdrawal summarized

  6. Feasibility: assessment completion rate

    Time frame: 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

  7. Feasibility: data completeness (proportion with complete primary endpoint data at Day 14)

    Time frame: 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.)

  8. Feasibility: acceptability of study

    Time frame: 14 days

    Participant-reported acceptability of study procedures by Day 14 (brief questionnaire or structured feedback)

  9. Feasibility: willingness to participate in a longer trial

    Time frame: 14 days

    Proportion of participants indicating willingness to participate in a longer (e.g., 1-year) trial using the same or similar procedures

  10. Safety/tolerability: serious adverese events

    Time frame: 14 days

    Proportion experiencing any adverse event by Day 14

  11. Safety/tolerability: related serious adverese events

    Time frame: 14 days

    Proportion considered related to interventions

Other outcomes

  1. muscle function

    Time frame: 14 days

    Change in muscle function based on 6MWT Test and knee extensor muscle strength measurements from Baseline to 14 days in the intervention compared to the control group;

  2. cognitive function

    Time frame: 14 days

    Change in Cognitive function based on the CANTAB® digital cognitive assessment tool from Baseline to 14 days in the intervention compared to the control group

  3. participant-reported outcome: Short Form (SF)-36 Health Survey

    Time frame: 14 days

    Change in participant-reported outcomes in the health-related quality of life (Short Form (SF)-36 Health Survey (SF-36)) questionnaire from baseline to 14 days in the intervention compared to the control group.

  4. participant-reported outcome: Perceived Stress Scale-10

    Time frame: 14 days

    Change in participant-reported outcomes in stress level (Perceived Stress Scale-10) from baseline to 14 days in the intervention compared to the control group.

  5. participant-reported outcome: Generalized Anxiety Disorder Screener (GAD-7)

    Time frame: 14 days

    Change in participant-reported outcome in self-reported anxiety (Generalized Anxiety Disorder Screener, GAD-7) from baseline to 14 days in the intervention compared to the control group.

  6. participant-reported outcome: infections

    Time frame: 14 days

    Change in participant-reported outcomes based on number of infections and sick days from baseline to 14 days in the intervention compared to the control group.

  7. blood pressure

    Time frame: 14 days

    Change in systolic and diastolic blood pressure from baseline to 14 days in the intervention compared to the control group.

  8. Arrhythmia

    Time frame: 14 days

    Incidence of arrhythmia in the electrocardiogram (ECG) from baseline to 14 days in the intervention compared to the control group.

  9. healthcare utilization costs

    Time frame: 14 days

    Healthcare utilization costs, assessed prospectively at baseline and 14 days with a simple questionnaire developed for DO-HEALTH.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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