Precision Medicine and Physical Function

ConditionsFrailty Weakness, Muscle Multiple Chronic Conditions

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65-85

SponsorUniversity of North Carolina, Chapel Hill

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

Beta-hydroxymethyl butyrate supplement
Dietary supplement
Beta-hydroxymethyl butyrate (750 mg) - Vitamin D3 (200 IU) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate with 200 IU of vitamin D3 per capsule. Frequency is 2 capsules twice daily (morning, evening)
Vitamin D supplement
Dietary supplement
Beta-hydroxymethyl butyrate (750 mg) - Vitamin D3 (200 IU) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate with 200 IU of vitamin D3 per capsule. Frequency is 2 capsules twice daily (morning, evening)
Matching Beta-hydroxymethyl butyrate supplement without Vitamin D
Dietary supplement
Beta-hydroxymethyl butyrate (750 mg) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate per capsule. Frequency is 2 capsules twice daily (morning, evening)

Treatment groups

25 Participants

are divided into 1 treatment group

Group A: Participants with WeaknessExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Percentage of Participants Enrolled

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.

Time frame

at 12-weeks

Number of Participants Screened

Feasibility of study procedures as measured by the number of participants that were 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).

Percentage of participants consented

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.

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).

Percent attendance

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

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).

Secondary outcomes

Change in weight from baseline

Absolute change in weight in kilograms (kg) over time from baseline to 12-weeks. Weight will be objectively measured on a digital scale. A negative number will indicate weight loss.

Time frame

At baseline, 6 weeks, and 12 weeks

Change in waist circumference from baseline

Absolute change in waist circumference in centimeters (cm) over time from baseline to 12-weeks. Waist circumference will be measured objectively using a tape measure. A negative number will indicate a loss in waist circumference

Time frame

At baseline, 6 weeks, and 12 weeks

Change in hip circumference from baseline

Absolute change in hip circumference in centimeters (cm) over time from baseline to 12-weeks. Hip circumference will be measured objectively using a tape measure. A negative number will indicate a loss of hip circumference

Time frame

At baseline, 6 weeks, and 12 weeks

Change in arm circumference from baseline

Change in arm circumference in centimeters (cm) over time from baseline to 12-weeks. Arm circumference will be measured objectively using a tape measure. A negative number will indicate a loss in arm circumference.

Time frame

At baseline, 6 weeks, and 12 weeks

Other outcomes

Change in interleukin 5 (IL-5) blood levels from baseline

Measures the absolute change in interleukin 5 serum from baseline as picograms per milliliter (pg/mL). The Mayo Clinic reference range for interleukin 5 serum is equal to or less than 2.1 picograms per milliliter (pg/mL). Results are used to understand the pathophysiology of immune, infectious, or inflammatory disorders.

Time frame

At baseline and 12 weeks

Change in interleukin 13 (IL-13) blood levels from baseline

Measures the absolute change in interleukin 13 serum from baseline as picograms per milliliter (pg/mL). The Mayo Clinic reference range for interleukin 13 serum is equal to or less than 2.3 picograms per milliliter (pg/mL). Results are used to understand the pathophysiology of immune, infectious, or inflammatory disorders.

Time frame

At baseline and 12 weeks

Change in interleukin 2 (IL-2) blood levels from baseline

Measures the absolute change in interleukin 2 serum from baseline as picograms per milliliter (pg/mL). The Mayo Clinic reference range for interleukin 2 serum is equal to or less than 2.1 picograms per milliliter (pg/mL). Results are used to understand the pathophysiology of immune, infectious, or inflammatory disorders.

Time frame

At baseline and 12 weeks

Change in blood glucose levels from baseline

Measures the absolute change in glucose levels from baseline as milligrams per deciliter (mg/dL). The Mayo Clinic reference range for glucose levels is between 80 milligrams per deciliter (mg/dL) and 130 milligrams per deciliter (mg/dL) before meals.

Time frame

At baseline and 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

North Carolina Translational and Clinical Sciences Institute

Collaborator

Source ClinicalTrials.gov

Apply now