A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate theEffects of Calcium Alpha-Ketoglutarate Supplementation on BiologicalAging, Physical Performance, and Metabolic Health in Middle-Aged andOlder Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in PhenoAge from Baseline to Week 12
研究概览
简要总结
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effects of calcium alpha-ketoglutarate (CaAKG) supplementation on biological aging and age-related health indicators in middle-aged and older adults. Alpha-ketoglutarate (AKG), a key intermediate in the Krebs cycle, has been investigated for its potential role in modulating aging-related metabolic and cellular pathways. Due to the poor oral bioavailability of free AKG, its stabilized form-calcium alpha-ketoglutarate (CaAKG)-is used to enhance absorption and additionally provides calcium supplementation benefits. At the population level, there is currently a lack of systematic assessment studies on the effects of CaAKG on human ageing-related indicators.
The study will recruit generally healthy adults aged 45 to 75 years. Participants will be randomly assigned to receive either CaAKG or a placebo daily for 12 weeks. The primary objective is to assess changes in biological aging, as measured by PhenoAge. Secondary outcomes include changes in physical performance, inflammatory markers, glucose and lipid metabolism, ageing-related gene expression, and self-reported quality of life.
This trial is designed to provide evidence on the efficacy and safety of CaAKG as a potential dietary intervention to support healthy aging. All participants will undergo pre- and post-intervention assessments. The study has been reviewed and approved by Medical Ethics Committee of Zhejiang Chinese Medical University, and informed consent will be obtained from all participants prior to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40-75 years old, no gender restrictions.
- •Has not taken any other anti-ageing research products in the past two months.
- •Able to use a smartphone.
- •Informed consent, voluntarily signed informed consent form, and agreed to participate in all visits and treatments in accordance with the trial protocol.
排除标准
- •Patients with cardiovascular disease, severe/uncontrolled hypertension, rheumatic heart disease, congenital heart disease, deep vein thrombosis, or pulmonary embolism .
- •Patients with Type I/Type II diabetes (treated with oral metformin or insulin) or diabetes complications .
- •Patients with cancer or who have undergone surgery, systemic drug therapy, or radiation therapy within the past 3 years.
- •Chronic obstructive pulmonary disease (COPD), severe asthma (requiring daily medication).
- •Multiple sclerosis, autoimmune/immunodeficiency disorders.
- •Recent history of sepsis or infection (hospitalisation within the past 3 months).
- •Any mental illness or neurodegenerative disease.
- •Any metallic implants in the body.
- •Hepatitis/cirrhosis.
- •Severe kidney disease (GFR <30 mL/min/1.73 m²).
- •Suffering from other conditions deemed unsuitable for participation in this trial (as determined by the investigator).
结局指标
主要结局
Change in PhenoAge from Baseline to Week 12
时间窗: Baseline and Week 12
Phenotypic Age (PhenoAge) is a composite biomarker-based estimate of biological age. The primary outcome is the change in PhenoAge from baseline to the end of the 12-week intervention period. PhenoAge will be calculated using the algorithm developed by Levine et al. (2018), based on a validated mortality risk model.
次要结局
- Change in Calcium Content of Bone(Baseline and Week 12)
- Change in β-Galactosidase Activity(Baseline and Week 12)
- Change in Age-related Gene Expression(Baseline and Week 12)
- Change in Grip strength(Baseline,12-week study)
- Change in body Weight(Baseline and Week 12)
- Change in body mass index(BMl)(Baseline and Week 12)
- Change in body fat mass(Baseline and Week 12)
- Change in alkaline phosphatase (ALP)(Baseline and Week 12)
- Change in body fat percentage(Baseline and Week 12)
- Change in fat-free mass(Baseline and Week 12)
- Change in muscle mass(Baseline and Week 12)
- Change in body water(Baseline and Week 12)
- Change in blood creatinine (CREA)(Baseline and 12-week study.)
- Change in protein(Baseline and Week 12)
- Change in inorganic salts(Baseline and Week 12)
- Change in TotalT lymphocytes (CD3+)(Baseline and Week 12)
- Change in helper T cells(cD4+)(Baseline and Week 12)
- Change in cytotoxicT cells(CD8+)(Baseline and Week 12)
- Change in Glycated haemoglobin (HbAlc)(Baseline and Week 12)
- Change in Fasting blood glucose(Baseline and Week 12)
- Change in Fasting insulin(Baseline and Week 12)
- Change in Physical activity questionnaire Scores(Baseline and Week 12)
- Change in number of finger taps in one minute(Baseline and Week 12)