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Status unknownNCT04332562BHB-RCTUpdated Apr 2, 2020

The Association Between Serum β-hydroxybutyrate and Levels of Systemic Hypertension

An interventional study of dietary restriction (salt restriction) in Hypertension, Essential and β-hydroxybutyrate, sponsored by Sulaiman AlRajhi Colleges. Status unknown. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-02.

Sponsored by Sulaiman AlRajhi Colleges · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension, Essential
  • β-hydroxybutyrate

Keywords

  • β-hydroxybutyrate
  • Hypertension
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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)

Interventions

  • Otherdietary restriction (salt restriction)

    salt restriction for one week after being diagnosed with hypertension

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 week

Secondary outcomes

  1. 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) .

    Time frame: 2 weeks

  2. 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 ) .

    Time frame: 2 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04332562
Lead sponsor
Sulaiman AlRajhi Colleges
Responsible party
Sponsor
First posted
Apr 2, 2020
Start date
Apr 15, 2020 (estimated)
Primary completion
Sep 1, 2020 (estimated)
Completion
Dec 28, 2020 (estimated)
Last update
Apr 2, 2020

Study contacts

Muaaz K. Mohammed
Contact
14110026@srcolleges.org
00966536336912
Hossam M. Sherif, MD
Contact
h.sherif@sr.edu.sa
00966581329900
Hossam Sherif, MD
principal investigator · Sulaiman Alrajhi University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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