α-ketoglutarate in Patients With Hypertension

NCT ID: NCT06445244

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2024-08-31

Brief 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

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

α-KG group

AKG Double Wood® + lifestyle modification

Group Type: EXPERIMENTAL

Alpha-ketoglutarate supplied as 1000mg capsule

Intervention Type: DIETARY_SUPPLEMENT

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: Lifestyle modification

Intervention Type: BEHAVIORAL

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.

Control group

Lifestyle modification only

Group Type: OTHER

Behavioral: Lifestyle modification

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1、 Primary hypertension (office blood pressure: systolic blood pressure 130～159 mmHg and/or diastolic blood pressure 80～99 mmHg, which meets the diagnostic criteria of hypertension class 1 of 2018AHA hypertension guidelines) and accompanied by vascular dysfunction (FMD<5%); 2、 Age between 18 and 65 years old; 3, Not using any drugs and dietary supplements that affect blood pressure and vascular endothelial function in the last 3 months, mainly including antihypertensive, lipid-lowering, hypoglycemic drugs and natural plant extract antioxidants; 4、 Voluntarily sign the informed consent form after fully understanding the purpose and process of the study, disease characteristics, drug effects, methods of relevant examinations, and potential risks/benefits of the study.

Exclusion Criteria

1. Presence of secondary hypertension (those who have been diagnosed with secondary hypertension in the past and have not been definitively cured, and if secondary hypertension is suspected, a complete examination is required to exclude common secondary hypertension, including renal hypertension (renal parenchymal lesions, renal artery stenosis), primary aldosteronism, Cushing's syndrome, pheochromocytoma, aortic constriction, and severe obstructive sleep apnea);

2. Acute myocardial infarction within the past 6 months;

3. recent history of stroke (within 6 months); 4, Dilated heart disease, hypertrophic cardiomyopathy, rheumatic heart disease, congenital heart disease, severe heart valve disease (severe valve stenosis and or regurgitation);

5. patients with a combination of serious physical illnesses, such as cancer; 6, Severe hepatic or renal dysfunction (ALT and or AST) ≥ 3 times the upper limit of normal, or dialysis end-stage renal disease or eGFR < 30 ml/min/1.73 m2, or serum creatinine > 2.5 mg/dL [> 221 μmol/L]); 7. Symptomatic heart failure or reduced left ventricular ejection fraction (<40%) within the past 6 months; 8. History of hypersensitivity to the study drug or to its components after administration; 9. Participating in other clinical studies; 10. Patients with mental illness who are unable to cooperate; 11, Pregnant, lactating or expectant mothers;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jun Tao

OTHER

Sponsor Role: lead

Responsible Party

Jun Tao

Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-Sen University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xia Wenhao, MD, PhD

Role: STUDY_CHAIR

Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University

Locations

Wenhao Xia

Guangxi, Nanning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xia Wenhao, MD, PhD

Role: CONTACT

xiawhao@mail.sysu.cn

+86 15818193120

Liu Zhefu

Role: CONTACT

liuzhf29@mail2.sysu.edu.cn

+86 18774082778

Facility Contacts

Xia Wenhao, MD,PhD

Role: primary

xiawhao@mail.sysu.edu.cn

+8615818193120

Liu Zhefu

Role: backup

liuzhf29@mail2.sysu.edu.cn

+8618774082778

Other Identifiers

KY-IIT-2024-001

Identifier Type: -

Identifier Source: org_study_id