Clinical trial NCT05877846: Precision Medicine and Physical Function
Official title: A Precision Nutrition Approach to Enhancing Physical Function in Older Adults: A Pilot, Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Weakness, Muscle
Multiple Chronic Conditions
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2023-05-26
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This pilot study is a 12-week, single arm, pre/post intervention of β-hydroxymethyl butyrate (HMB) in n=18 older adults at risk for sarcopenia. There will be no randomization.
Primary purpose: OTHER

Brief summary: 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)


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Enrolled
timeFrame: at 12-weeks
measure: Number of Participants Screened
timeFrame: Through the end of the study period (~1 year) based on data collected on each participant at the conclusion of the study intervention (12-weeks).
measure: Percentage of participants consented
timeFrame: Through the end of the study period (~1 year) based on data collected on each participant at the conclusion of the study intervention (12-weeks).
measure: Percent attendance
timeFrame: Through the end of the study period (~1 year) based on data collected on each participant at the conclusion of the study intervention (12-weeks).
measure: Percent of Interviews completed
timeFrame: Through the end of the study period (~1 year) based on data collected on each participant at the conclusion of the study intervention (12-weeks).
measure: Percentage of study measures collected
timeFrame: 12 weeks after baseline visit
measure: Percent of participants conducted MRI measure
timeFrame: 12 weeks after baseline visit
measure: Percent of participants conducted ultrasound measure
timeFrame: 12 weeks after baseline visit
measure: Acceptability of study intervention
timeFrame: 12 weeks after baseline visit
measure: Percent of Participants Rating the Intervention as Acceptable
timeFrame: 12 weeks after baseline visit
measure: Percent of participants rating the intervention as appropriate
timeFrame: 12 weeks after baseline visit
measure: Percent of participants rating the intervention as feasible
timeFrame: 12 weeks after baseline visit
Secondary outcomes:
measure: Change in weight from baseline
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in waist circumference from baseline
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in hip circumference from baseline
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in arm circumference from baseline
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in calf circumference from baseline
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Language using the Picture Vocabulary Test
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Executive function using the Dimensional Change Card Sort Test
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Episodic memory using the Picture sequence memory test
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Working memory using the List Sorting Test
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Processing speed using the Pattern Comparison Test
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in caloric intake
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Changes in total cholesterol blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Changes in low density lipoprotein blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Changes in triglycerides blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in high density lipoprotein blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in C-reactive protein blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in Tumor Necrosis Factor- alpha (TNF-a) blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in Interleukin 1 beta (IL-1-beta) blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in Interleukin 6 (IL6) blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in stool alpha-diversity levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in serum sample from baseline
timeFrame: At baseline and 12 weeks
measure: Change in 30-second sit-to-stand from baseline
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in grip strength from baseline
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in gait speed from baseline
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in 400-meter walk time from baseline
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Fat Mass
timeFrame: At baseline and 12 weeks
measure: Change in Fractional Percentage of Fat Mass
timeFrame: At baseline and 12 weeks
measure: Change in Fractional Percentage of Lean Mass
timeFrame: At baseline and 12 weeks
measure: Change in Lean Mass Volume
timeFrame: At baseline and 12 weeks
measure: Change in Fractional Percentage Visceral Mass
timeFrame: At baseline and 12 weeks
measure: Change in Ultrasound Imaging Intensity
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Pittsburgh Fatigability Scale
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Patient reported outcomes measurement information systems (PROMIS) General Health
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Rates of Physical Activity Type
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Metabolic equivalents
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Caloric Expenditure with Exercise
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Social Support for Diet
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Change in Social support for exercise
timeFrame: At baseline, 6 weeks, and 12 weeks
measure: Compliance Rate of b-hydroxymethylbutyrate
timeFrame: Weekly up to 12 weeks
measure: Change in hemoglobin A1C blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in very low density lipoprotein blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in interleukin 2 (IL-2) receptor serum levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in interferon gamma serum levels from baseline
timeFrame: At baseline and 12 weeks
Other outcomes:
measure: Change in interleukin 5 (IL-5) blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in interleukin 13 (IL-13) blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in interleukin 2 (IL-2) blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in blood glucose levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in non-high density lipoprotein (non-HDL) blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in interleukin 12 (IL-12) blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in interleukin 4 (IL-4) blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in interleukin 10 (IL-10) blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in interleukin 8 (IL-8) blood levels from baseline
timeFrame: At baseline and 12 weeks
measure: Change in interleukin 17 (IL-17) blood levels from baseline
timeFrame: At baseline and 12 weeks
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: John Batsis, MD, AGSF
role: PRINCIPAL_INVESTIGATOR
References: