HypertensionAKGHTNNCT06445244
α-ketoglutarate in Patients With Hypertension
A study testing Alpha-ketoglutarate supplied as 1000mg capsule and Behavioral: Lifestyle modification in people with Hypertension, run by Jun Tao at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Alpha-ketoglutarate supplied as 1000mg capsule and Behavioral: Lifestyle modification
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
- Acute myocardial infarction within the past 6 months;
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wenhao Xia
Guangxi, Nanning, 530028
Xia Wenhao, MD,PhD, +8615818193120, xiawhao@mail.sysu.edu.cn
Liu Zhefu, +8618774082778, liuzhf29@mail2.sysu.edu.cn
About this study
Official title: The Effects of α-ketoglutarate on Blood Pressure and Endothelial Function in Hypertensive Patients
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
- Being tested
- Alpha-ketoglutarate supplied as 1000mg capsule, Behavioral: Lifestyle modification
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-ketoglutarate supplied as 1000mg capsuleDietary 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 modificationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| α-KG group | Experimental | AKG Double Wood® + lifestyle modification Receives: Dietary Supplement: Alpha-ketoglutarate supplied as 1000mg capsule; Behavioral: Behavioral: Lifestyle modification |
| Control group | Other | Lifestyle modification only Receives: Behavioral: Behavioral: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of αKG on flow mediated dilation （FMD）
Change of FMD between αKG-treated participants and non-αKG-treated participants
Measured: Up to 1 month
Effect of αKG on brachial-ankle pulse wave velocity （baPWV）
Change of baPWV between αKG-treated participants and non-αKG-treated participants
Measured: Up to 1 month
Secondary outcomes (3)
Effect of αKG on blood pressure
Change of systolic blood pressure and diastolic blood pressure between αKG-treated participants and non-αKG-treated participants
Measured: Up to 1 month
Effect of αKG on serum αKG levels
Change of serum αKG levels between αKG-treated participants and non-αKG-treated participants
Measured: Up to 1 month
Effect of αKG on retinal vascular density
Change of retinal vascular density between αKG-treated participants and non-αKG-treated participants
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start30 May 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Tao, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xia Wenhao, MD, PhD, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445244
- Sponsor's protocol ID
- KY-IIT-2024-001
- Acronym
- AKGHTN
- Status last verified
- May 2024
- First submitted
- 31 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of α-ketoglutarate on Blood Pressure and Endothelial Function in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT06445244
- Acronym / sponsor ID
- AKGHTN / KY-IIT-2024-001
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jun TaoUniversity, hospital or other
- Study start
- 30 May 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| α-KG group | Experimental | Dietary Supplement: Alpha-ketoglutarate supplied as 1000mg capsule, Behavioral: Behavioral: Lifestyle modificationAKG Double Wood® + lifestyle modification |
| Control group | Other | Behavioral: Behavioral: Lifestyle modificationLifestyle modification only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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);
- Acute myocardial infarction within the past 6 months;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-ketoglutarate supplied as 1000mg capsuleAKG 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. | Dietary supplement | α-KG group |
| Behavioral: Lifestyle modificationLifestyle 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. | Behavioural | Control group, α-KG group |
Primary outcome
Effect of αKG on flow mediated dilation （FMD）
Time frame: Up to 1 month
Change of FMD between αKG-treated participants and non-αKG-treated participants
Effect of αKG on brachial-ankle pulse wave velocity （baPWV）
Time frame: Up to 1 month
Change of baPWV between αKG-treated participants and non-αKG-treated participants
3 secondary outcomes
Effect of αKG on blood pressure
Time frame: Up to 1 month
Effect of αKG on serum αKG levels
Time frame: Up to 1 month
Effect of αKG on retinal vascular density
Time frame: Up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xia Wenhao, MD, PhD study chair
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-ketoglutarate supplied as 1000mg capsule and Behavioral: Lifestyle modification in people with Hypertension, run by Jun Tao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xia Wenhao, MD, PhD (+86 15818193120, xiawhao@mail.sysu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of αKG on flow mediated dilation （FMD） (time frame: Up to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.