The Association Between Serum β-hydroxybutyrate and Levels of Systemic Hypertension (BHB-RCT)
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|ClinicalTrials.gov Identifier: NCT04332562|
Recruitment Status : Not yet recruiting
First Posted : April 2, 2020
Last Update Posted : April 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Essential β-hydroxybutyrate||Other: dietary restriction (salt restriction)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: normotensive control group
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
- 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.
- 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) .
- 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 ) .
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 ClinicalTrials.gov identifier (NCT number): NCT04332562
|Contact: Muaaz K. Mohammedfirstname.lastname@example.org|
|Contact: Hossam M. Sherif, MDemail@example.com|
|Principal Investigator:||Hossam Sherif, MD||Sulaiman Alrajhi University|