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NCT Number: NCT07107386

Temporal Investigation of Multimodal Elements

The TIME Study is a research project aiming to understand the body's natural rhythms. The goal is to see how daily and weekly changes in our bodies-from what's happening at a molecular level to data from wearable devices-are connected.

What is the study about? This study is trying to create a detailed map of how a person's body changes over time. By looking at information from blood, urine, and other samples, as well as data from smartwatches and other devices, researchers want to learn how our bodies' natural cycles work in healthy older adults. The long-term goal is to use this knowledge to help develop more personalized healthcare in the future.

Who can participate? The study is looking for healthy adults, age 55 or older, who have a smartphone and are able to travel to the Buck Institute in Novato, California, for study visits.

Participants will be asked to:

Attend weekly visits over 11 weeks to provide blood and other samples.

Wear health-tracking devices like a smart ring and watch.

Use a smartphone app to answer questions about their daily routines.

Complete two "challenge" tests, including drinking a glucose solution and exercising on a stationary bicycle.

Return for follow-up visits after 6 and 12 months.

Are there any risks or benefits? Benefits: There are no direct health benefits for participants. However, the information gained will help scientists create better diagnostic tools and treatments for future generations.

Risks: The main risks are minor discomfort from things like blood draws or skin irritation from the wearable devices. All personal information and data are kept private and secure.

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Key information

Conditions

Health

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Buck Institute

Novato, California, 94945, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults aged 55 years or older.
  • Own a smartphone capable of running study-specific apps.
  • Willing and able to attend in-person visits at the Buck Institute in Novato, CA.
  • Reside in the Pacific or Mountain Time Zones.
  • Able to speak, read, and write English.
  • Willing to wear study devices continuously and allow researchers access to all data.
  • Able to provide informed consent.

Exclusion criteria

  • Hospitalization within the last 3 months.
  • Needing assistance with daily living activities.
  • Working night or irregular shifts.
  • Certain musculoskeletal, pulmonary, or cardiovascular conditions.
  • Uncontrolled high blood pressure (BP > 180/100 mmHg).
  • Bleeding disorders, anemia requiring treatment, or recent blood donation.
  • Poor vein access.
  • Unstable health conditions.
  • Chronic antibiotic use.
  • Certain psychiatric disorders.
  • Use of excluded medications, supplements, or products, including certain antibiotics or frequent sleep aids.

Treatment and study plan

Primary outcomes

  1. Generation of a longitudinal multi-omic and digital health dataset characterizing biorhythms in older adults

    Time frame: 12 months

    Establish a publicly shareable reference dataset integrating blood-based proteomic, metabolomic, and lipidomic profiles with continuous digital health data and microbiome samples from healthy older adults over time, capturing daily, weekly, and perturbation-induced physiological dynamics.

Secondary outcomes

  1. Characterization of associations between molecular biomarkers and digital health data across time

    Time frame: 12 months

    Identify and quantify temporal correlations between blood-derived molecular biomarkers and physiological signals collected via wearable devices, including responses to standardized challenges.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Buck Institute for Research on Aging

Other

Collaborators

  • Phenome Health

Registry information

Official study title

An Observational, Longitudinal Study to Characterize the Dynamic Structure of Molecular and Digital Health Data in Healthy Older Adults

Acronym: TIME

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 6, 2025
Registry last updated
Aug 15, 2025

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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