Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07087093

Effects of Ketone Esters on Circulating Senescent T Lymphocytes (T Cells) and Inflammation Levels in the Elderly

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital, Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location status: Recruiting

Location contact

Mei Jiao He, Doctor

CONTACT

[email protected]

86-451-85555673

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 65~80 years old.
  • The subjects are in good health, and no history of chronic diseases.

Exclusion criteria

  • Have used immunosuppressants or hormone drugs in the past six months.
  • There has been a significant change in diet within the past month.
  • Having digestive tract surgery within one year.
  • Severe liver dysfunction (alanine aminotransferase level > 3.0 upper limit of normal).
  • Severe kidney dysfunction (creatinine clearance rate < 30 mL/min).
  • History of malignant tumor.

Treatment and study plan

Ketone ester

Other

KetoneAid Ke4 Pro Ketone Ester:20ml, tid po

Primary outcomes

  1. T cell senescence level (Protein 53、Protein 21 and Protein 16)

    Time frame: From enrollment to the end of treatment at 2 weeks

    Expression of protein 53、protein 21 and protein 16 in human plasma used by western blot.

Secondary outcomes

  1. Circulating inflammatory factor levels (monocyte chemoattractant protein-1 and interleukin-6)

    Time frame: From enrollment to the end of treatment at 2 weeks

    Expression of monocyte chemoattractant protein-1 and interleukin-6 in human plasma used by enzyme linked immunosorbent assay.

  2. Ankle-brachial index

    Time frame: From enrollment to the end of treatment at 2 weeks

    The ankle-brachial index value was measured by dopplex ankle-brachial index detector.

Other outcomes

  1. Ejection fraction (EF) levels

    Time frame: From enrollment to the end of treatment at 2 weeks

    Use cardiac echocardiography to assess the ejection fraction level

  2. NT-proBNP level

    Time frame: From enrollment to the end of treatment at 2 weeks

    NT-proBNP level was used by chemiluminescence immunoassay.

Study contacts

Contact information is provided by the study sponsor or research team.

Yue Li, Doctor

CONTACT

[email protected]

86-451-85555673

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Harbin Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.