An interventional study of Ketone ester in The Elderly, sponsored by First Affiliated Hospital of Harbin Medical University. Recruiting at 1 site in China. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by First Affiliated Hospital of Harbin Medical University · Not applicable, Interventional, and Treatment
Studies have shown that aging can promote a variety of pathological processes, such as myocardial remodeling and cardiac dysfunction caused by ischemia-reperfusion injury and pressure load. Previous studies found that the level of circulating beta-hydroxybutyric acid decreased significantly with age. It has been reported that the ketogenic diet reduces the occurrence of tumors and neurodegenerative diseases in mice, improves motor coordination and endurance, and ultimately extends life span. Current research results have confirmed that ketone bodies have multiple mechanisms to exert beneficial effects on cardiovascular diseases. However, the effect of age-related cardiovascular disease has not been reported.
In order to further clarify the role of beta-hydroxybutyric acid in age-related cardiovascular diseases, find new intervention targets for elderly cardiovascular diseases, and develop new effective prevention and treatment measures for elderly cardiovascular diseases. We will further investigate this hypothesis by establishing a clinical cohort of the elderly population.
It is predicted that by 2050, the total number of people over 65 years old in China will reach 400 million (accounting for 26.9% of the total population), and the number of people over 80 years old will reach 150 million. Population aging is the main driving force of cardiovascular diseases, and cardiovascular diseases in the elderly will become a major clinical problem threatening the health of our people and a social problem involving people's livelihood. Therefore, it is an important research direction in the cardiovascular field to deeply explore the pathogenesis of elderly cardiovascular diseases and find effective prevention and control targets.
Studies have shown that aging can promote a variety of pathological processes, such as myocardial remodeling and cardiac dysfunction caused by ischemia-reperfusion injury and pressure load. Previous studies found that the level of circulating beta-hydroxybutyric acid decreased significantly with age. It has been reported that the ketogenic diet reduces the occurrence of tumors and neurodegenerative diseases in mice, improves motor coordination and endurance, and ultimately extends life span. Current research results have confirmed that ketone bodies have multiple mechanisms to exert beneficial effects on cardiovascular diseases. However, the effect of age-related cardiovascular disease has not been reported.
In order to further clarify the role of beta-hydroxybutyric acid in age-related cardiovascular diseases, find new intervention targets for elderly cardiovascular diseases, and develop new effective prevention and treatment measures for elderly cardiovascular diseases. We will further investigate this hypothesis by establishing a clinical cohort of the elderly population.
First Affiliated Hospital of Harbin Medical University is the lead sponsor of 74 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Ketone ester
KetoneAid Ke4 Pro Ketone Ester：20ml, tid po
T cell senescence level (Protein 53、Protein 21 and Protein 16)
Expression of protein 53、protein 21 and protein 16 in human plasma used by western blot.
Time frame: From enrollment to the end of treatment at 2 weeks
Circulating inflammatory factor levels (monocyte chemoattractant protein-1 and interleukin-6)
Expression of monocyte chemoattractant protein-1 and interleukin-6 in human plasma used by enzyme linked immunosorbent assay.
Time frame: From enrollment to the end of treatment at 2 weeks
Ankle-brachial index
The ankle-brachial index value was measured by dopplex ankle-brachial index detector.
Time frame: From enrollment to the end of treatment at 2 weeks
Ejection fraction (EF) levels
Use cardiac echocardiography to assess the ejection fraction level
Time frame: From enrollment to the end of treatment at 2 weeks
NT-proBNP level
NT-proBNP level was used by chemiluminescence immunoassay.
Time frame: From enrollment to the end of treatment at 2 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2025, 11 months after the start.
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First Affiliated Hospital of Harbin Medical University