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
About this trial
This is an interventional other trial for Hypertension, Essential focused on measuring β-hydroxybutyrate, Hypertension
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.
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
NCT ID
NCT04332562
First Posted
January 20, 2020
Last Updated
April 1, 2020
Sponsor
Sulaiman AlRajhi Colleges
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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The Association Between Serum β-hydroxybutyrate and Levels of Systemic Hypertension
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