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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
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
HMB
2016
N/A
~200
Sodium
2012
N/A
~130
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Who is running the clinical trial?
Augusta UniversityLead Sponsor
211 Previous Clinical Trials
84,988 Total Patients Enrolled
American Heart AssociationOTHER
333 Previous Clinical Trials
4,934,083 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I identify as black or white and am between 18 and 65 years old.I am on medication that affects my blood pressure or gut health.I am between 18 and 65 years old.I have a health condition that affects how my body handles sodium.
Research Study Groups:
This trial has the following groups:- Group 1: Sodium active, HMB placebo
- Group 2: Sodium active, HMB active
- Group 3: Sodium placebo, HMB placebo
- Group 4: Sodium placebo, HMB active
Awards:
This trial has 0 awards, including: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.
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