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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
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
HMB Trial 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.Check my eligibility
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.See study design
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.
HMB Trial 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).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of study intervention
Number of Participants Screened
Percent attendance
+9 moreSecondary outcome measures
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 moreOther outcome measures
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 moreHMB 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
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,800 Total Patients Enrolled
North Carolina Translational and Clinical Sciences InstituteOTHER
56 Previous Clinical Trials
4,278 Total Patients Enrolled
John Batsis, MD, AGSFPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My severe COPD stops me from participating fully.I am between 65 and 85 years old and speak English.You have a subjective weakness score of less than 1.I am younger than 65 or older than 85.I have been diagnosed with dementia.I have planned surgery within the next four months.I cannot follow the study's required procedures.Your vitamin D levels are higher than 80 ng/dL.My liver is failing severely.I am on hemodialysis for chronic kidney failure.You have a very serious illness and are receiving special end-of-life care.I am taking medication that helps with weight loss.I was hospitalized for heart failure in the last 6 months.I am currently being treated for advanced cancer that is not skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Weakness
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conclusions is the research team striving to reach with this investigation?
"This 12-week trial is primarily assessing the Number of Participants Screened; secondary metrics include alterations in weight (as measured on a digital scale), hip circumference (measured with a tape measure) and arm circumference (again, recorded using a measuring tape). Negative numbers suggest loss."
Answered by AI
Is it possible for me to become a participant of this clinical trial?
"To participate in this clinical trial, the prospective patient must demonstrate debility and be within an age range of 65-85 years old. Moreover, there is a recruitment quota of 25 individuals."
Answered by AI
Are any individuals aged 45 and above eligible to participate in the trial?
"The parameters for participation in this trial necessitate that participants fall between 65 and 85 years of age. In total, there are 33 studies zeroing-in on patients younger than 18 and 305 concentrating on individuals over the senior threshold."
Answered by AI
Are there still available slots in this trial for new participants?
"Details published on clinicaltrials.gov suggest that this investigation is no longer looking for participants; the trial was initially publicized on July 1st, 2023 and last revised on May 23rd, 2023. Despite that there are still 343 other trials actively seeking patients at present time."
Answered by AI
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