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HMB + Salt for High Blood Pressure

N/A
Recruiting
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial seeks to understand the role of leucine in salt-induced hypertension and gut microbiome alteration.

Who is the study for?
This trial is for adults aged 18 to 65 with normal blood pressure, who are not on medication affecting blood pressure or gut microbiome, not pregnant, and can handle sodium normally. It's specifically for those who identify as black or white.Check my eligibility
What is being tested?
The study tests the effects of HMB (a compound from leucine metabolism) and sodium supplements on blood pressure and gut bacteria diversity. Participants will be randomly assigned to receive either HMB, sodium, or a placebo in a double-blind setup.See study design
What are the potential side effects?
While the side effects are not detailed here, potential risks may include changes in blood pressure levels due to sodium intake and possible digestive alterations from impacting the gut microbiome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood pressure
Gut microbiome
Leucine/α-KIC/HMB metabolism

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Sodium placebo, HMB activeExperimental Treatment1 Intervention
The subjects in this group will take placebo pills from baseline to week 8, and take HMB pills of 3 g/day from week 5 to week 8 while on reduced-sodium diet.
Group II: Sodium active, HMB placeboExperimental Treatment1 Intervention
The subjects in this group will take sodium pills of 2,000 mg/day from baseline to week 8, and take placebo pills of 3 g/day from week 5 to week 8 while on reduced-sodium diet.
Group III: Sodium active, HMB activeExperimental Treatment2 Interventions
The subjects in this group will take sodium pills of 2,000 mg/day from baseline to week 8, and take HMB pills of 3 g/day from week 5 to week 8 while on reduced-sodium diet.
Group IV: Sodium placebo, HMB placeboPlacebo Group1 Intervention
The subjects in this group will take placebo pills from baseline to week 8 while on reduced-sodium diet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium
2012
N/A
~130
HMB
2016
N/A
~200

Find a Location

Who is running the clinical trial?

Augusta UniversityLead Sponsor
211 Previous Clinical Trials
84,988 Total Patients Enrolled
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,546 Total Patients Enrolled

Media Library

HMB (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05515900 — N/A
High Blood Pressure Research Study Groups: Sodium active, HMB placebo, Sodium active, HMB active, Sodium placebo, HMB placebo, Sodium placebo, HMB active
High Blood Pressure Clinical Trial 2023: HMB Highlights & Side Effects. Trial Name: NCT05515900 — N/A
HMB (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05515900 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for this research project?

"The trial is still open for enrollment as indicated by clinicaltrials.gov; the research was initially posted on October 1st 2021 and has been recently modified on August 23rd 2022."

Answered by AI

Are applicants who are below a certain age eligible for this research project?

"The eligibility parameters for this trial necessitate that the potential participants must be aged between 18 and 65. There are additional 5 clinical trials specifically designed for people under 18, with 82 available to those over 65 years old."

Answered by AI

How many participants have been approved for involvement in this research project?

"Affirmative. Details present on clinicaltrials.gov indicate that this trial, which launched on October 1st 2021, is presently conducting participant recruitment. A total of 80 participants from a single location must be enrolled to complete the study."

Answered by AI

Who can sign up to take part in these clinical trials?

"This clinical trial is accepting 80 participants aged 18-65 who present with normotensive blood pressure levels (systolic <140 mmHg and diastolic <90mmHg). Additionally, only Black or White individuals may apply."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
What site did they apply to?
Augusta University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Salt and HMB Study
2021. "Salt and HMB Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05515900.
~11 spots leftby Sep 2024
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