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The Association Between Serum β-hydroxybutyrate and Levels of Systemic Hypertension (BHB-RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04332562
Recruitment Status : Not yet recruiting
First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Information provided by (Responsible Party):
Sulaiman AlRajhi Colleges

Brief Summary:
In this research the investigators are looking for the direct relationship between Beta-hydroxybutyrate and hypertension. Since recent research showed a connection between exercise and hypertension, and diet control and hypertension. The investigators are studying the possible effect of beta-hydroxybutyrate levels on blood pressure control.

Condition or disease Intervention/treatment Phase
Hypertension, Essential β-hydroxybutyrate Other: dietary restriction (salt restriction) Not Applicable

Detailed Description:

Systemic hypertension is defined as a systolic blood pressure that is ≥ 140 mm hg and / or a diastolic blood pressure that is ≥ 90 mm hg a modifiable and it is known to be a serious risk factor for cardiovascular disease. Exercise is widely recommended as a lifestyle modification for hypertensive patients because of its beneficial effect on lowering blood pressure (BP). Similarly, calorie restriction is also documented to lower systemic hypertension.

Interestingly, both exercise and calorie-restriction are associated with increased circulating levels of ketone bodies such as β-hydroxybutyrate (βHB). β-Hydroxybutyrate (βHB; 3-hydroxybutyric acid) is a "ketone body" which is produced the liver, mainly from the oxidation of fatty acids, and is exported to peripheral tissues for use as an energy source. It is transported to extrahepatic tissues, and traditionally recognized as a vital alternative source of energy during starvation. However, recent evidences indicate that apart from serving as energy fuel, ketone bodies such as βHB block nucleotide-binding domain, leucine-rich-containing family, pyrin domain-containing-3 (Nlrp3)-inflammasome-mediated inflammatory diseases, and thereby play a prominent role in maintaining physiological homeostasis parameter such as blood pressure.

Among environmental factors, excessive salt intake is the most common and important risk factor for hypertension, in which patient with salt-sensitive hypertension demonstrated an increased risk of cardiovascular disease. There is substantial evidence suggesting that blood pressure's (BP) response to dietary salt intake vary considerably among individuals which is a phenomenon described as salt sensitivity of blood pressure.

Another reference demonstrated a lower circulating level of the ketone body, beta-hydroxybutyrate (βHB), in high salt-fed hypertensive rats. Despite the high salt intake, the specific rescue of (βHB) levels by nutritional supplementation of its precursor, 1,3-butanediol, attenuates hypertension and protects kidney function by inhibiting the renal Nlrp3 inflammasome in rats.

Existing Knowledge and Literature Review: PubMed search builder was used to construct the following search entry: hypertension AND β-Hydroxybutyrate. The initial search yielded 39 titles. Studies (RCTs or systemic reviews) relevant to the research question were isolated manually by reading the abstracts. However, due to the novelty of the idea, the investigators were not able to identify any related literature except of "Chakraborty, Saroj" study. which was a non-human research.

Research impact: The current evidence regarding the effect of β-Hydroxybutyrate supplementation on the reduction of salt-sensitive hypertension was only proven on a non-human level. The research will address this gap in knowledge by looking for any relationship between the levels of (βHB) and salt-sensitive hypertensive in human subjects, which may change the current understanding of the treatment of salt-sensitive.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Association Between Serum β-hydroxybutyrate and Levels of Systemic Hypertension: "An Open-label Randomized Controlled Trial.
Estimated Study Start Date : April 15, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
No Intervention: normotensive control group
Normotensive volunteer
No Intervention: hypertensive control group
Hypertensive patients with no restriction on their salt intake
Experimental: hypertensive interventional group
intervention is going to be salt restriction
Other: dietary restriction (salt restriction)
salt restriction for one week after being diagnosed with hypertension

Primary Outcome Measures :
  1. scanning for levels of circulating βHB mmol/L in the serum of the participant [ Time Frame: 1 week ]
    scanning for levels of circulating βHB in mmol/L in the serum of the hypertensive arm in comparison to the control arm.

Secondary Outcome Measures :
  1. The correlation between the salt intake restriction and it is effect on the blood pressure in (mmHg) . [ Time Frame: 2 weeks ]
    Hypertensive participant on salt restriction to under go a serial measurement of their blood pressure ( mmHg) .

  2. The effect of salt intake (restriction) on the serum level of βHB mmol/L. [ Time Frame: 2 weeks ]
    Hypertensive participants on salt intake restriction to under go a serial measures of the serum βHB levels mmol/L , looking for any correlation ( if any ) .

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria for:

  1. All patients ≥ 18 years
  2. not diagnosed with systemic hypertension

Inclusion Criteria for:

  1. All patients ≥ 18 years
  2. First time diagnosed as a case of systemic hypertension

Exclusion Criteria:

  1. Diabetes mellitus.
  2. Previous heart diseases, kidney or liver diseases as these conditions may interfere with the serum levels of β-hydroxybutyrate.
  3. Patients using diuretics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04332562

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Contact: Muaaz K. Mohammed 00966536336912
Contact: Hossam M. Sherif, MD 00966581329900

Sponsors and Collaborators
Sulaiman AlRajhi Colleges
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Principal Investigator: Hossam Sherif, MD Sulaiman Alrajhi University
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Responsible Party: Sulaiman AlRajhi Colleges Identifier: NCT04332562    
Other Study ID Numbers: SulaimanAC- BHB
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sulaiman AlRajhi Colleges:
Additional relevant MeSH terms:
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Essential Hypertension
Vascular Diseases
Cardiovascular Diseases