Menu
Recruiting NCT07087093

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

No phase Interventional The Elderly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketone ester.
Who it may be relevant to
Registry conditions: The Elderly. Basic parameters: 65 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Ketone ester
    KetoneAid Ke4 Pro Ketone Ester:20ml, tid po

Primary outcome measures

  • T cell senescence level (Protein 53、Protein 21 and Protein 16) [Time frame: From enrollment to the end of treatment at 2 weeks]
Secondary outcome measures (2)
  • Circulating inflammatory factor levels (monocyte chemoattractant protein-1 and interleukin-6) [Time frame: From enrollment to the end of treatment at 2 weeks]
  • Ankle-brachial index [Time frame: From enrollment to the end of treatment at 2 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • the First Affiliated Hospital, Harbin Medical University — Harbin

Identifiers

NCT: NCT07087093 · Ketone Esters-2024214

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗