🏛️ Verified NIH Record • Updated 2026-02-12

Precision Medicine and Physical Function (NCT05877846)

A Precision Nutrition Approach to Enhancing Physical Function in Older Adults: A Pilot, Feasibility Study

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: University of North Carolina, Chapel Hill

🩺 Plain-English Summary (8th-Grade Level)

The investigators aim to conduct a 12-week, single-arm, pre/post-intervention of b-hydroxy-methylbutyrate in persons aged 65 to 85 years to assess feasibility and acceptability of the intervention and study procedures, secondary outcomes of physical function and changes in multi-omics patterns, and exploratory outcomes that will allow the team to describe physical function phenotype. The investigators' primary outcomes are the: feasibility of the study procedures (including safety), feasibility of the intervention delivery, and acceptability of study procedures and measures. Secondary outcomes include: Objective and subjective physical function measures that predict disability including the 30-second sit-to-stand, knee strength, isokinetic strength, grip strength, gait speed, 400-m walk test, Pittsburgh Fatiguability, PROMIS global health-10, social support, anthropometry, National Institutes of Health (NIH) Cognitive toolbox, Automated Self-Administered 24-hour Dietary Assessment (ASA-24), Community Healthy Activities Model Programs (CHAMPS), Ultrasound Imaging, Magnetic Resonance Imaging (MRI), Changes in untargeted metabolomic profile data based on qualitative or semiquantitative analysis of the most probable detectable metabolites in laboratory samples , Discover potential metabolites that explain changes in physical function using a discovery science, precision medicine approach (discovery science approach that is exploratory)

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (17 items).

Location: University of North Carolina at Chapel Hill — Chapel Hill, North Carolina

Age range: 65 Years to 85 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Age \<65 years and \>85 years old
  • A medical diagnosis of dementia
  • Those without a negative subjective weakness screener (\<1)
  • Individuals with life-threatening or untreated psychiatric diagnosis that would interfere with study participation and require significant modification to meet their needs such as untreated major depressive disorder, substance abuse, suicidal ideation or untreated severe mental illness (schizophrenia, bipolar disorder)
  • Life-threatening illness including those receiving palliative care or hospice services
  • Individuals unwilling/unable to provide consent
  • Inability to complete the protocol procedures
  • Elective surgery in the next four months
  • Medications - antiobesity (weight loss agents) medications that lead to weight loss
  • Hospitalization for heart failure in past 6 months, advanced non-skin cancer (Stage III or IV) on treatment; Advanced liver failure; Chronic renal insufficiency on hemodialysis; advanced Chronic obstructive pulmonary disease (COPD) that would prevent engagement \*\*\*Vitamin D \>80 ng/dL:
  • At baseline, the investigators will check Vit D levels - recognize that processing is highly dependent on the McLendon lab and may take up to 7+ days to come back.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • University of North Carolina at Chapel Hill — Chapel Hill, North Carolina

📞 Contact the Study Coordinator

Phone: (919) 445-6776

Email: dcgross@unc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗