α-ketoglutarate in Patients With Hypertension

NCT06445244 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-06-06

No results posted yet for this study

Summary

Cardiovascular and cerebrovascular diseases are most terrible killers endangering the health of Chinese residents, and hypertension is the most important risk factor. Hypertension related microvascular rarefaction and endothelial dysfunction are the common pathological basis and initiation of cardiovascular and cerebrovascular disease. Therefore, reducing blood pressure and delaying or reversing endothelial dysfunction is an effective way to treat hypertension and prevent cardiovascular disease. Alpha-ketoglutarate (αKG) is a critical metabolic intermediate in the tricarboxylic acid (TCA) cycle, involves in diverse cellular biological activities, such as central metabolism, antioxidative defense, epigenetic regulation, and cell proliferation. The latest research found that with the growth of age, the level of αKG is decreasing, and increasing the content of αKG can prolong the life of multiple species including human. Recent clinical trials found that αKG supplementation can effectively improve the level of αKG in cells, delay aging, improve the metabolic process of cells without adverse reactions. However, the effect of αKG supplementation on reducing blood pressure and protecting vascular endothelial function has not been reported. Therefore, this study aims to focus on hypertension, a major chronic disease, and to observe the effects of αKG supplementation on endothelial function and blood pressure in patients with hypertension, so as to provide a new treatment strategy for hypertension and associated endothelial dysfunction.

Conditions

Interventions

DIETARY_SUPPLEMENT

Alpha-ketoglutarate supplied as 1000mg capsule

AKG Double Wood® + lifestyle modification AKG Double Wood®: 500mg, qd, for one months. Lifestyle modification: intake 1400-1600 kcal/day: 54% carbohydrates, 24% proteins, 22% lipids, 108 mg cholesterol, 35 g fiber; avoid smoking and alcohol consumption; performing aerobic activity 4 days per week such as 45 min on a stationary bicycle.

BEHAVIORAL

Behavioral: Lifestyle modification

Lifestyle modification: intake 1400-1600 kcal/day: 54% carbohydrates, 24% proteins, 22% lipids, 108 mg cholesterol, 35 g fiber; avoid smoking and alcohol consumption; performing aerobic activity 4 days per week such as 45 min on a stationary bicycle.

Sponsors & Collaborators

  • Jun Tao

    lead OTHER

Principal Investigators

  • Xia Wenhao, MD, PhD · Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2024-07-01
Completion
2024-08-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06445244 on ClinicalTrials.gov