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

NCT07087093 | Recruiting

• 1 other identifier: Ketone Esters-2024214
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

The Elderly

Keywords

ketone ester; the eldly; Senescent T cell; inflammatory factors

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (2)

• 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

Other Outcomes (2)

• Ejection fraction (EF) levels

  From enrollment to the end of treatment at 2 weeks

• NT-proBNP level

  From enrollment to the end of treatment at 2 weeks

Study Arms (1)

Ketone ester group

EXPERIMENTAL

Other: Ketone ester

Interventions

Ketone ester OTHER

KetoneAid Ke4 Pro Ketone Ester：20ml, tid po

Ketone ester group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

the First Affiliated Hospital, Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Interventions

formic acid 4-(3-oxobutyl)phenyl ester

Central Study Contacts

Yue Li, Doctor

CONTACT

86-451-85555673; ly99ly@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: July 25, 2025
• Study Start: January 7, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)