A Precision Nutrition Approach to Enhancing Physical Function in Older Adults: A Pilot, Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Acceptability of study intervention
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to 85 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Participants with Weakness
Participants will take beta-hydroxymethyl butyrate (HMB) with vitamin D3 for 12 weeks. Those participants with vitamin D3 levels > 80 ng/dL will be provided intervention capsules without vitamin D3.
Intervention: Beta-hydroxymethyl butyrate supplement (Dietary Supplement)
Participants with Weakness
Participants will take beta-hydroxymethyl butyrate (HMB) with vitamin D3 for 12 weeks. Those participants with vitamin D3 levels > 80 ng/dL will be provided intervention capsules without vitamin D3.
Intervention: Vitamin D supplement (Dietary Supplement)
Participants with Weakness
Participants will take beta-hydroxymethyl butyrate (HMB) with vitamin D3 for 12 weeks. Those participants with vitamin D3 levels > 80 ng/dL will be provided intervention capsules without vitamin D3.
Intervention: Matching Beta-hydroxymethyl butyrate supplement without Vitamin D (Dietary Supplement)
Outcomes
Primary Outcomes
Acceptability of study intervention
Time Frame: 12 weeks after baseline visit
Measured through an end of study satisfaction survey, acceptability is measured on a 10 point Likert scale conducted on all participants at 12-weeks. This is rated on a 1 (strongly disagree) to 10 (strongly agree) survey.
Percent of Interviews completed
Time Frame: 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).
Feasibility of study procedures measures as interview completion rate. Percent of completed interviews = (# of completed interviews / # of participants completing the intervention) x 100. There are no cut-off scores for interpretation. Higher rates are indicative of higher feasibility.
Percent of participants conducted ultrasound measure
Time Frame: 12 weeks after baseline visit
Rate of participants who conducted three ultrasound measures, defined as the total number of MRI measures collected divided by the total expected number of ultrasound measures. A higher number indicates feasibility of obtaining ultrasound measures.
Percent of participants rating the intervention as appropriate
Time Frame: 12 weeks after baseline visit
Conducted on all participants using a 1-5 Likert scale to assess appropriateness of the study intervention measures using the following: completely disagree, disagree, neither agree or disagree, agree, completely agree. Intervention appropriateness is reported as Agree or Completely Agree responses. Rate is calculated as total number of participants rating as agree or complete agree divided by the number of total participants.
Percentage of Participants Enrolled
Time Frame: at 12-weeks
Feasibility of study procedures is measured by the percentage of enrolled participants that were screened (percent participants enrolled = number of participants enrolled/number of participants screened x 100). There are no cut-off scores for interpretation but, higher scores indicate greater feasibility of the study.
Number of Participants Screened
Time Frame: 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).
Feasibility of study procedures as measured by the number of participants that were screened.
Percentage of participants consented
Time Frame: 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).
The percent of participants that consented in the study is defined as the number of participants that were consented divided by the # of participants screened multiplied by 100. There are no cut-off scores for interpretation but, higher scores indicate greater feasibility of the study.
Percent of Participants Rating the Intervention as Acceptable
Time Frame: 12 weeks after baseline visit
Conducted on all participants using a 1-5 Likert scale to assess appropriateness of the study intervention measures using the following: completely disagree, disagree, neither agree or disagree, agree, completely agree. Acceptability is reported as Agree or Completely Agree responses. Rate is calculated as total number of participants rating as agree or complete agree divided by the number of total participants.
Percentage of study measures collected
Time Frame: 12 weeks after baseline visit
Rate of the percent of study measures collected, defined as the # of study procedures collected divided by the total # of proposed study procedures x 100. A higher number is characteristic of increased feasibility of collecting study measures.
Percent of participants conducted MRI measure
Time Frame: 12 weeks after baseline visit
Rate of participants who conducted two MRI measures, defined as the total number of MRI measures collected divided by the total expected number of MRI measures. A higher number indicates feasibility of obtaining MRI measures.
Percent attendance
Time Frame: 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).
Feasibility of study procedures measured as the mean attendance rate of all participants. Participant attendance rate = (total # of visits attended / total # of visits scheduled) x 100. There are no cut-off scores for interpretation. Higher scores indicate higher feasibility
Percent of participants rating the intervention as feasible
Time Frame: 12 weeks after baseline visit
Conducted on all participants using a 1-5 Likert scale to assess feasibility of the study intervention measures using the following: completely disagree, disagree, neither agree or disagree, agree, completely agree. Intervention feasibility is reported as Agree or Completely Agree responses. Rate is calculated as total number of participants rating as agree or complete agree divided by the number of total participants.
Secondary Outcomes
- Change in weight from baseline(At baseline, 6 weeks, and 12 weeks)
- Change in caloric intake(At baseline, 6 weeks, and 12 weeks)
- Change in waist circumference from baseline(At baseline, 6 weeks, and 12 weeks)
- Change in arm circumference from baseline(At baseline, 6 weeks, and 12 weeks)
- Change in Executive function using the Dimensional Change Card Sort Test(At baseline, 6 weeks, and 12 weeks)
- Change in Processing speed using the Pattern Comparison Test(At baseline, 6 weeks, and 12 weeks)
- Change in hip circumference from baseline(At baseline, 6 weeks, and 12 weeks)
- Change in Language using the Picture Vocabulary Test(At baseline, 6 weeks, and 12 weeks)
- Change in Episodic memory using the Picture sequence memory test(At baseline, 6 weeks, and 12 weeks)
- Change in Working memory using the List Sorting Test(At baseline, 6 weeks, and 12 weeks)
- Change in calf circumference from baseline(At baseline, 6 weeks, and 12 weeks)
- Changes in low density lipoprotein blood levels from baseline(At baseline and 12 weeks)
- Changes in triglycerides blood levels from baseline(At baseline and 12 weeks)
- Change in Interleukin 6 (IL6) blood levels from baseline(At baseline and 12 weeks)
- Change in 30-second sit-to-stand from baseline(At baseline, 6 weeks, and 12 weeks)
- Change in Fractional Percentage of Fat Mass(At baseline and 12 weeks)
- Change in Fat Mass(At baseline and 12 weeks)
- Changes in total cholesterol blood levels from baseline(At baseline and 12 weeks)
- Change in Interleukin 1 beta (IL-1-beta) blood levels from baseline(At baseline and 12 weeks)
- Change in stool alpha-diversity levels from baseline(At baseline and 12 weeks)
- Change in serum sample from baseline(At baseline and 12 weeks)
- Change in Lean Mass Volume(At baseline and 12 weeks)
- Change in Fractional Percentage Visceral Mass(At baseline and 12 weeks)
- Change in Ultrasound Imaging Intensity(At baseline, 6 weeks, and 12 weeks)
- Change in high density lipoprotein blood levels from baseline(At baseline and 12 weeks)
- Change in grip strength from baseline(At baseline, 6 weeks, and 12 weeks)
- Change in 400-meter walk time from baseline(At baseline, 6 weeks, and 12 weeks)
- Change in Pittsburgh Fatigability Scale(At baseline, 6 weeks, and 12 weeks)
- Change in hemoglobin A1C blood levels from baseline(At baseline and 12 weeks)
- Change in interleukin 2 (IL-2) receptor serum levels from baseline(At baseline and 12 weeks)
- Change in C-reactive protein blood levels from baseline(At baseline and 12 weeks)
- Change in Tumor Necrosis Factor- alpha (TNF-a) blood levels from baseline(At baseline and 12 weeks)
- Change in Patient reported outcomes measurement information systems (PROMIS) General Health(At baseline, 6 weeks, and 12 weeks)
- Change in Metabolic equivalents(At baseline, 6 weeks, and 12 weeks)
- Compliance Rate of b-hydroxymethylbutyrate(Weekly up to 12 weeks)
- Change in gait speed from baseline(At baseline, 6 weeks, and 12 weeks)
- Change in Fractional Percentage of Lean Mass(At baseline and 12 weeks)
- Change in Rates of Physical Activity Type(At baseline, 6 weeks, and 12 weeks)
- Change in Caloric Expenditure with Exercise(At baseline, 6 weeks, and 12 weeks)
- Change in Social Support for Diet(At baseline, 6 weeks, and 12 weeks)
- Change in very low density lipoprotein blood levels from baseline(At baseline and 12 weeks)
- Change in interferon gamma serum levels from baseline(At baseline and 12 weeks)
- Change in Social support for exercise(At baseline, 6 weeks, and 12 weeks)