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.

Study Overview

• Status: Recruiting
• Conditions: Aging
• Intervention / Treatment: Other: multimodal lifestyle intervention:

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heike A Bischoff-Ferrari, Prof. Dr. med., DrPH; Phone Number: +41 61 326 40 22; Email: ha.bischoff-ferrari@felixplatter.ch
• Study Contact Backup: Name: Michele Mattle, Dr. sc. med.; Phone Number: +41 61 326 45 43; Email: michele.mattle@felixplatter.ch

Study Locations

• Switzerland
  • Canton of Basel-City
    • Basel, Canton of Basel-City, Switzerland, 4055
      • Recruiting
      • Universitäre Altersmedizin Felix Platter
      • Contact: Michele Mattle, Dr. sc. med.; Phone Number: +41 61 326 45 43; Email: michele.mattle@felixplatter.ch
      • Principal Investigator: Heike A Bischoff-Ferrari, Prof. Dr. med., DrPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Active Comparator: multimodal intervention	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: eligibility rate	Proportion of screened individuals who meet Inclusion/Exclusion Criteria (eligibility rate), and the most common reasons for ineligibility by criterion	baseline
Feasibility: recruitment rate	Recruitment rate (participants enrolled per week) and total time required to enroll n=10	baseline
Feasibility: enrollment rate	Proportion of eligible individuals who provide consent and are enrolled	baseline
Feasibility: Retention	Proportion of enrolled participants who complete the Day 14 visit	14 days
Feasibility: drop-out rate	Proportion of enrolled participants who withdraw prior to Day 14, with reasons for withdrawal summarized	14 days
Feasibility: assessment completion rate	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	14 days
Feasibility: data completeness (proportion with complete primary endpoint data at Day 14)	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.)	14 days
Feasibility: acceptability of study	Participant-reported acceptability of study procedures by Day 14 (brief questionnaire or structured feedback)	14 days
Feasibility: willingness to participate in a longer trial	Proportion of participants indicating willingness to participate in a longer (e.g., 1-year) trial using the same or similar procedures	14 days
Safety/tolerability: serious adverese events	Proportion experiencing any adverse event by Day 14	14 days
Safety/tolerability: related serious adverese events	Proportion considered related to interventions	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle function	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;	14 days
cognitive function	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	14 days
participant-reported outcome: Short Form (SF)-36 Health Survey	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.	14 days
participant-reported outcome: Perceived Stress Scale-10	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.	14 days
participant-reported outcome: Generalized Anxiety Disorder Screener (GAD-7)	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.	14 days
participant-reported outcome: infections	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.	14 days
blood pressure	Change in systolic and diastolic blood pressure from baseline to 14 days in the intervention compared to the control group.	14 days
Arrhythmia	Incidence of arrhythmia in the electrocardiogram (ECG) from baseline to 14 days in the intervention compared to the control group.	14 days
healthcare utilization costs	Healthcare utilization costs, assessed prospectively at baseline and 14 days with a simple questionnaire developed for DO-HEALTH.	14 days

Collaborators and Investigators

• Sponsor: Heike A. Bischoff-Ferrari, Prof. Dr. med., DrPH
• Investigators: Principal Investigator: Heike A Bischoff-Ferrari, Prof. Dr. med., DrPH, Universitäre Altersmedizin Felix Platter

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: accelerated aging; pilot trial; multimodal intervention; precision age
• Other Study ID Numbers: EKNZ_2026-00476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No