PrecisionAge Pilot Study

June 26, 2026 updated by: Heike A. Bischoff-Ferrari, Prof. Dr. med., DrPH
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4055
        • Universitäre Altersmedizin Felix Platter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline
Feasibility: recruitment rate
Time Frame: baseline
Recruitment rate (participants enrolled per week) and total time required to enroll n=10
baseline
Feasibility: enrollment rate
Time Frame: baseline
Proportion of eligible individuals who provide consent and are enrolled
baseline
Feasibility: Retention
Time Frame: 14 days
Proportion of enrolled participants who complete the Day 14 visit
14 days
Feasibility: drop-out rate
Time Frame: 14 days
Proportion of enrolled participants who withdraw prior to Day 14, with reasons for withdrawal summarized
14 days
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
14 days
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.)
14 days
Feasibility: acceptability of study
Time Frame: 14 days
Participant-reported acceptability of study procedures by Day 14 (brief questionnaire or structured feedback)
14 days
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
14 days
Safety/tolerability: serious adverese events
Time Frame: 14 days
Proportion experiencing any adverse event by Day 14
14 days
Safety/tolerability: related serious adverese events
Time Frame: 14 days
Proportion considered related to interventions
14 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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;
14 days
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
14 days
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.
14 days
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.
14 days
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.
14 days
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.
14 days
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.
14 days
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.
14 days
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.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heike A. Bischoff-Ferrari, Prof. Dr. med., DrPH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heike A Bischoff-Ferrari, Prof. Dr. med., DrPH, Universitäre Altersmedizin Felix Platter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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