Temporal Investigation of Multimodal Elements

NCT07107386 | Recruiting

• 2 other identifiers: BUCK 25021AY2AX000072-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 months

Secondary Outcomes (1)

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

  12 months

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of healthy older adults aged 55 years or older.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Buck Institute for Research on Aging: lead
• Phenome Health: collaborator

Study Sites (1)

Buck Institute

Novato, California, 94945, United States

RECRUITING

Study Officials

• James Yurkovich, PhD

  Phenome Health, The Buck Institute for Research on Aging

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brianna Stubbs, Research Assistant Professor, PhD.

CONTACT

(415) 209-2072; TIME-Study@buckinstitute.org

Alison Le, Project Manager

CONTACT

TIME-Study@buckinstitute.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

US (1)