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Dietary Supplement

HMB + Vitamin D Supplements for Frailty (HMB Trial)

N/A

Recruiting

Led By John Batsis, MD, AGSF

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Must not have

Advanced Chronic obstructive pulmonary disease (COPD) that would prevent engagement

Age <65 years and >85 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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).

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to assess feasibility, safety, and acceptability of a b-hydroxy-methylbutyrate intervention in elderly individuals and how it affects physical function, nutrition, and cognitive health.

Who is the study for?

This trial is for English-speaking adults aged 65 to 85 who are patients at UNC Geriatrics Medicine clinic and have chronic conditions as defined by Medicare. It's not for those with dementia, life-threatening illnesses, certain psychiatric diagnoses, recent heart failure hospitalization, advanced cancer on treatment, severe liver or kidney disease, advanced COPD or high Vitamin D levels.

What is being tested?

The study tests a Beta-hydroxymethyl butyrate supplement with and without Vitamin D over 12 weeks in older adults. It aims to see if the supplements are feasible and acceptable to take while looking at their effects on physical function and changes in biological markers related to health.

What are the potential side effects?

While specific side effects aren't listed here, common ones from supplements like these could include digestive discomforts such as nausea or diarrhea. Since it's a feasibility study, part of its purpose is also to monitor any potential side effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My severe COPD stops me from participating fully.

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I am younger than 65 or older than 85.

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I have been diagnosed with dementia.

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I cannot follow the study's required procedures.

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My liver is failing severely.

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I am on hemodialysis for chronic kidney failure.

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I am taking medication that helps with weight loss.

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I was hospitalized for heart failure in the last 6 months.

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I am currently being treated for advanced cancer that is not skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of study intervention

Number of Participants Screened

Percent attendance

+9 more

Secondary study objectives

Change in 30-second sit-to-stand from baseline

Change in 400-meter walk time from baseline

Change in C-reactive protein blood levels from baseline

+40 more

Other study objectives

Change in blood glucose levels from baseline

Change in interleukin 10 (IL-10) blood levels from baseline

Change in interleukin 12 (IL-12) blood levels from baseline

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with WeaknessExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin D supplement

2020

Completed Phase 3

~1220

0 / 9Eligibility criteria met