Sodium active, HMB active for Blood Pressures

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Augusta University, Augusta, GA
Blood Pressures
HMB - DietarySupplement
Eligibility
18+
All Sexes
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Study Summary

Hypertension affects one-third of adults in the US. High salt diet is a key risk factor for elevated blood pressure (BP). The associations of gut microbiome with high salt diet and hypertension have been established in both animal and human studies. However, the underlying biological mechanisms linking sodium to BP elevation and gut microbiome alteration are not clear. Increasing evidence supports a pivotal role of leucine metabolism in hypertension. Leucine is initially catalyzed by the branched-chain amino acid aminotransferase enzyme (BCAT), producing α-ketoisocaproate (α-KIC), which can be further metabolized to β-hydroxy-β-methylbutyrate (HMB). Leucine/α-KIC/HMB metabolism pathway shows a promising involvement in the relationships among salt, gut microbiome, and elevated BP. Preliminary studies show that dietary sodium reduction increases circulating HMB, which is further associated with reduced BP, and that HMB treatment decreases Firmicutes/Bacteroidetes ratio, and increases α-diversity and gut microbiota-derived short-chain fatty acids (SCFAs). However, the leucine/α-KIC/HMB metabolism pathway has never been targeted in human studies. To establish causality, I propose a double-blind, two-stage randomized, placebo-controlled trial of sodium and HMB supplements for the following specific aims: Aim 1 will determine the effect of sodium supplement on leucine/α-KIC/HMB metabolism pathway. Aim 2 will determine the effect of HMB supplement on office BP and 24-hour ambulatory BP (Aim 2a), and α- and β-diversities and Firmicutes/Bacteroidetes ratio (Aim 2b). Secondary Aim will test the hypothesis that HMB supplement could partially block the detrimental effects of sodium intake on BP and gut microbiota. The proposed project would help to uncover the role of leucine/α-KIC/HMB metabolism pathway in salt-induced hypertension and the alteration in gut microbiome. Most importantly, the project will provide the training opportunities for me as a junior faculty, to study the new area of gut microbiome, acquire new experience and skills to conduct human trials. In addition, this project will generate rich preliminary data on the role of leucine/α-KIC/HMB metabolism pathway in salt-induced BP elevation, and test the feasibility for developing future NIH R01 project.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Blood Pressures

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 4 weeks

4 weeks
Blood pressure
Gut microbiome
Leucine/α-KIC/HMB metabolism

Trial Safety

Safety Progress

1 of 3

Other trials for Blood Pressures

Trial Design

4 Treatment Groups

Sodium active, HMB active
1 of 4
Sodium placebo, HMB active
1 of 4
Sodium active, HMB placebo
1 of 4
Sodium placebo, HMB placebo
1 of 4
Experimental Treatment
Non-Treatment Group

80 Total Participants · 4 Treatment Groups

Primary Treatment: Sodium active, HMB active · Has Placebo Group · N/A

Sodium active, HMB activeExperimental Group · 2 Interventions: HMB, Sodium · Intervention Types: DietarySupplement, DietarySupplement
Sodium placebo, HMB active
DietarySupplement
Experimental Group · 1 Intervention: HMB · Intervention Types: DietarySupplement
Sodium active, HMB placebo
DietarySupplement
Experimental Group · 1 Intervention: Sodium · Intervention Types: DietarySupplement
Sodium placebo, HMB placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HMB
2016
N/A
~200
Sodium
2012
N/A
~80

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks
Closest Location: Augusta University · Augusta, GA
Photo of Augusta University  1Photo of Augusta University  2Photo of Augusta University  3
2019First Recorded Clinical Trial
4 TrialsResearching Blood Pressures
109 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.