PrecisionAge Pilot Study

NCT07523061 | Not Yet Recruiting DMC

• 1 other identifier: EKNZ_2026-00476
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging

Keywords

pilot trial; accelerated aging; precision age; multimodal intervention

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (9)

• muscle function

  14 days

• cognitive function

  14 days

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

  14 days

Study Arms (2)

multimodal intervention

ACTIVE COMPARATOR

Other: multimodal lifestyle intervention:

control

NO INTERVENTION

Interventions

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)

multimodal intervention

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heike A. Bischoff-Ferrari, Prof. Dr. med., DrPH: lead

Study Sites (1)

Universitäre Altersmedizin Felix Platter

Basel, Canton of Basel-City, 4055, Switzerland

Location

Study Officials

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

  Universitäre Altersmedizin Felix Platter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+41 61 326 40 22; ha.bischoff-ferrari@felixplatter.ch

Michèle Mattle, Dr. sc. med.

CONTACT

+41 61 326 45 43; michele.mattle@felixplatter.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair of Aging Medicine, University of Basel, Switzerland Dept. Chair, University of Basel Acute Aging Medicine Felix Platter, Basel, Switzerland Director, Swiss Healthy Longevity Campus

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 13, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)