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

Primary Purpose

Hypertension, Essential, β-hydroxybutyrate

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dietary restriction (salt restriction)
Sponsored by
Sulaiman AlRajhi Colleges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension, Essential focused on measuring β-hydroxybutyrate, Hypertension

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    No Intervention

    Experimental

    Arm Label

    normotensive control group

    hypertensive control group

    hypertensive interventional group

    Arm Description

    Normotensive volunteer

    Hypertensive patients with no restriction on their salt intake

    intervention is going to be salt restriction

    Outcomes

    Primary Outcome Measures

    scanning for levels of circulating βHB mmol/L in the serum of the participant
    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

    The correlation between the salt intake restriction and it is effect on the blood pressure in (mmHg) .
    Hypertensive participant on salt restriction to under go a serial measurement of their blood pressure ( mmHg) .
    The effect of salt intake (restriction) on the serum level of βHB mmol/L.
    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 ) .

    Full Information

    First Posted
    January 20, 2020
    Last Updated
    April 1, 2020
    Sponsor
    Sulaiman AlRajhi Colleges
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04332562
    Brief Title
    The Association Between Serum β-hydroxybutyrate and Levels of Systemic Hypertension
    Acronym
    BHB-RCT
    Official Title
    The Association Between Serum β-hydroxybutyrate and Levels of Systemic Hypertension: "An Open-label Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 15, 2020 (Anticipated)
    Primary Completion Date
    September 1, 2020 (Anticipated)
    Study Completion Date
    December 28, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sulaiman AlRajhi Colleges

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Essential, β-hydroxybutyrate
    Keywords
    β-hydroxybutyrate, Hypertension

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    normotensive control group
    Arm Type
    No Intervention
    Arm Description
    Normotensive volunteer
    Arm Title
    hypertensive control group
    Arm Type
    No Intervention
    Arm Description
    Hypertensive patients with no restriction on their salt intake
    Arm Title
    hypertensive interventional group
    Arm Type
    Experimental
    Arm Description
    intervention is going to be salt restriction
    Intervention Type
    Other
    Intervention Name(s)
    dietary restriction (salt restriction)
    Intervention Description
    salt restriction for one week after being diagnosed with hypertension
    Primary Outcome Measure Information:
    Title
    scanning for levels of circulating βHB mmol/L in the serum of the participant
    Description
    scanning for levels of circulating βHB in mmol/L in the serum of the hypertensive arm in comparison to the control arm.
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    The correlation between the salt intake restriction and it is effect on the blood pressure in (mmHg) .
    Description
    Hypertensive participant on salt restriction to under go a serial measurement of their blood pressure ( mmHg) .
    Time Frame
    2 weeks
    Title
    The effect of salt intake (restriction) on the serum level of βHB mmol/L.
    Description
    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 ) .
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria for: All patients ≥ 18 years not diagnosed with systemic hypertension Inclusion Criteria for: All patients ≥ 18 years First time diagnosed as a case of systemic hypertension Exclusion Criteria: Diabetes mellitus. Previous heart diseases, kidney or liver diseases as these conditions may interfere with the serum levels of β-hydroxybutyrate. Patients using diuretics.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Muaaz K. Mohammed
    Phone
    00966536336912
    Email
    14110026@srcolleges.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hossam M. Sherif, MD
    Phone
    00966581329900
    Email
    h.sherif@sr.edu.sa
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hossam Sherif, MD
    Organizational Affiliation
    Sulaiman Alrajhi University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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