Using supplements to improve physical function in older adults
A Precision Nutrition Approach to Enhancing Physical Function in Older Adults: A Pilot, Feasibility Study
This study is testing whether taking beta-hydroxy-methylbutyrate and vitamin D supplements for 12 weeks can help older adults aged 65 to 85 improve their physical function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05877846 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and acceptability of a 12-week intervention using beta-hydroxy-methylbutyrate and vitamin D supplements in older adults aged 65 to 85 years. Participants will be assessed for changes in physical function and multi-omics patterns before and after the intervention. The primary focus is on the feasibility of the study procedures and intervention delivery, while secondary outcomes include various objective and subjective measures of physical function. The study aims to gather data that could help describe the physical function phenotype in this population.
Who should consider this trial
Good fit: Ideal candidates are English-speaking older adults aged 65 to 85 years with chronic medical conditions.
Not a fit: Patients under 65 or over 85 years old, those with dementia, or individuals with untreated psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance physical function and quality of life for older adults with multiple chronic conditions.
How similar studies have performed: Other studies have shown promise in using nutritional supplements to improve physical function in older adults, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * English-speaking older adults aged 65 to 85 years (of all genders and sexes, race or ethnicity) * A University of North Carolina at Chapel Hill (UNC) Geriatrics Medicine clinic patient; * Chronic medical conditions -these are based on the 21 Medicare multiple chronic conditions (e.g., alcohol abuse, arthritis (osteoarthritis, rheumatoid), asthma, atrial fibrillation, autism spectrum disorders, cancer (breast, colorectal, lung, prostate), chronic kidney disease, chronic obstructive pulmonary disease, depression, diabetes, drug/substance abuse, heart failure, hepatitis, HIV/AIDS, hyperlipidemia, hypertension, ischemic heart disease, osteoporosis, schizophrenia/other psychotic disorders, stroke); 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. * Concurrently, the investigators will consider continuing consent, enrollment, study procedures. * Provide at Visit 2 the beta-hydroxymethyl butyrate/Vitamin D supplement * Once the results have been received and reviewed - if the levels exceed 80 ng/dL, then the participant will be informed. * At that point, the investigators will either exclude the participant or, if available, see whether the company is willing to provide formulations of just beta-hydroxymethyl butyrate (HMB)and provide this to the participant * These guidelines account for the fact that Vit D is not recommended by American Geriatrics Society to check routinely, and that levels \<80 (or even 120 ng/mL) rarely lead to toxicity.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: John Batsis, MD, AGSF — University of North Carolina, Chapel Hill
- Study coordinator: Danae C Gross, MS
- Email: dcgross@unc.edu
- Phone: (919)445-6776
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.