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Clinical Trials/NCT07087093
NCT07087093RecruitingNot Applicable

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

First Affiliated Hospital of Harbin Medical University2 sites in 1 country20 target enrollmentStarted: January 7, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
20
Locations
2
Primary Endpoint
T cell senescence level (Protein 53、Protein 21 and Protein 16)

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
65 Years to 80 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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.

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

  • Circulating inflammatory factor levels (monocyte chemoattractant protein-1 and interleukin-6)(From enrollment to the end of treatment at 2 weeks)
  • Ankle-brachial index(From enrollment to the end of treatment at 2 weeks)
  • Circulating inflammatory factor levels (monocyte chemoattractant protein-1 and interleukin-6)(From enrollment to the end of treatment at 2 weeks)
  • Ankle-brachial index(From enrollment to the end of treatment at 2 weeks)

Investigators

Sponsor
First Affiliated Hospital of Harbin Medical University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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