Effects of Ketone Esters on Circulating Senescent T Lymph... | NCT07087093

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

NCT07087093

Sponsor

First Affiliated Hospital of Harbin Medical University

Status

Recruiting

Last Update Posted

Jul 25, 2025Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

The Elderly

Interventions

Ketone ester

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2025Actual

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Mar 24, 2025

First Submission Date that Met QC Criteria

Jul 23, 2025

First Posted Date

Jul 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2025

Last Update Posted Date

Jul 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ketone ester group	Experimental		Other: Ketone ester

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ketone ester	Other	KetoneAid Ke4 Pro Ketone Ester：20ml, tid po	Ketone ester group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	From enrollment to the end of treatment at 2 weeks
Ankle-brachial index

Other Outcomes

Measure	Description	Time Frame
Ejection fraction (EF) levels	Use cardiac echocardiography to assess the ejection fraction level	From enrollment to the end of treatment at 2 weeks
NT-proBNP level	NT-proBNP level was used by chemiluminescence immunoassay.

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

80 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yue Li, Doctor	Contact	86-451-85555673		ly99ly@vip.163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Affiliated Hospital, Harbin Medical University	Recruiting	Harbin	Heilongjiang	150001	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C524675	formic acid 4-(3-oxobutyl)phenyl ester

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided