Aging
Conditions
Keywords
a-ketoglutaric acid, Phenoage*age, Healthy aging
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCalcium-a-ketoglutarate
Description: Participants in the intervention group will receive oral calcium alpha-ketoglutarate (CaAKG) in granular tablet form. Each tablet contains 0.5 grams of CaAKG.Participants will take two tablets twice daily (morning and evening). The total daily dose is 2 grams. The intervention period will last for 12 weeks. CaAKG is a stabilized form of alpha-ketoglutarate that enhances bioavailability and provides supplemental calcium. The tablets are identical in appearance and texture to those in the placebo group to maintain blinding.
OTHERPlacebo(starch)
Participants in the placebo group will receive oral tablets identical inappearance and texture to the CaAKG tablets, but containing starch with no active calciumalpha-ketoglutarate. Each tablet weighs 0.5 grams. Participants will take two tablets twicedaily (morning and evening), for a total daily intake of 2 grams. The placebo tablets arepackaged and administered in the same manner as the CaAKG tablets to ensure blindingthroughout the 12-weekintervention period.
Sponsors
Shenzhen Hygieia Biotech Co., Ltd
Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 40-75 years old, no gender restrictions. 2. Has not taken any other anti-ageing research products in the past two months. 3. Able to use a smartphone. 4. Informed consent, voluntarily signed informed consent form, and agreed to participate in all visits and treatments in accordance with the trial protocol.
Exclusion criteria
1. Patients with cardiovascular disease, severe/uncontrolled hypertension, rheumatic heart disease, congenital heart disease, deep vein thrombosis, or pulmonary embolism . 2. Patients with Type I/Type II diabetes (treated with oral metformin or insulin) or diabetes complications . 3. Patients with cancer or who have undergone surgery, systemic drug therapy, or radiation therapy within the past 3 years. 4. Chronic obstructive pulmonary disease (COPD), severe asthma (requiring daily medication). 5. Multiple sclerosis, autoimmune/immunodeficiency disorders. 6. Recent history of sepsis or infection (hospitalisation within the past 3 months). 7. Any mental illness or neurodegenerative disease. 8. Any metallic implants in the body. 9. Hepatitis/cirrhosis. 10. Severe kidney disease (GFR \<30 mL/min/1.73 m²). 11. Suffering from other conditions deemed unsuitable for participation in this trial (as determined by the investigator).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PhenoAge from Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Calcium Content of Bone | Baseline and Week 12 | The calcium content of bone will be measured at baseline and at Week 12 to evaluate changes resulting from CaAKG supplementation. Bone calcium will be assessed using dual-energy X-ray absorptiometry (DXA) with mineral content analysis at specific skeletal sites. The primary metric is the change in bone calcium content (mg/cm2 or mg) over the 12-week intervention period. |
| Change in β-Galactosidase Activity | Baseline and Week 12 | β-Galactosidase activity will be measured in serum collected at baseline and at Week 12. |
| Change in Age-related Gene Expression | Baseline and Week 12 | e.g., SIRT1\~7、TERT/TERC、p21(CDKN1A)、p16INK4a(CDKN2A)、PDGFRB、PLOD1、MAP4K4、NFKBIA、GFAP、F2RL3、HERPUD1、PPPIR15A、PCBP1、TFAM、MMP7 |
| Change in Grip strength | Baseline,12-week study | The change in Grip strength (kg) of 30 volunteers before and after the intervention was measured. |
| Change in body Weight | Baseline and Week 12 | The change in body weight (kg) of 30 volunteers before and after the intervention was measured. |
| Change in body mass index(BMl) | Baseline and Week 12 | The change in Body Mass Index (BMl) kg/m2 of 30 volunteers before and after the intervention was measured. |
| Change in body fat mass | Baseline and Week 12 | The change in body fat mass(kg) of 30 volunteers before and after the intervention was measured. |
| Change in alkaline phosphatase (ALP) | Baseline and Week 12 | The change in alkaline phosphatase (ALP) in U/L of 30 volunteers before and after the intervention was measured. |
| Change in body fat percentage | Baseline and Week 12 | The change in body fat percentage (%) of 30 volunteers before and after the intervention was measured. |
| Change in fat-free mass | Baseline and Week 12 | The change in fat-free mass(kg) of 30 volunteers before and after the intervention was measured. |
| Change in muscle mass | Baseline and Week 12 | The change in muscle mass (kg) of 30 volunteers before and after the intervention was measured. |
| Change in body water | Baseline and Week 12 | The change in body water (kg) of 30 volunteers before and after the intervention was measured. |
| Change in blood creatinine (CREA) | Baseline and 12-week study. | The change in blood creatinine (CREA) in mol/L of 30 volunteers before and after the intervention was measured. |
| Change in protein | Baseline and Week 12 | The change in protein (kg) of 30 volunteers before and after the intervention was measured. |
| Change in inorganic salts | Baseline and Week 12 | The change in inorganic salts (kg) of 30 volunteers before and after the intervention was measured. |
| Change in TotalT lymphocytes (CD3+) | Baseline and Week 12 | The change in TotalT lymphocytes (CD3+) (cells/μl) of 30 volunteers before and after the intervention was measured. |
| Change in helper T cells(cD4+) | Baseline and Week 12 | The change in helper T cells (CD4+) (cells/μl) of 30 volunteers before and after the intervention was measured. |
| Change in cytotoxicT cells(CD8+) | Baseline and Week 12 | The change in cytotoxic T cells (CD8+)(cells/μL) of 30 volunteers before and after the intervention was measured. |
| Change in Glycated haemoglobin (HbAlc) | Baseline and Week 12 | The change in Glycated haemoglobin (HbA1c) (%) of 30 volunteers before and after the intervention was measured. |
| Change in Fasting blood glucose | Baseline and Week 12 | The change in Fasting blood glucose (mmol/L) of 30 volunteers before and after the intervention was measured. |
| Change in Fasting insulin | Baseline and Week 12 | The change in Fasting insulin (pmol/L) of 30 volunteers before and after the intervention was measured. |
| Change in Physical activity questionnaire Scores | Baseline and Week 12 | International Physical Activity Questionnaire - Long Form (IPAQ-LF). At baseline and 12 weeks, measure changes in participants' Physical activity questionnaire scores. There is no fixed upper or lower limit to the total score, but scores at different activity intensities (walking, moderate intensity, high intensity) can be accumulated based on metabolic equivalents (MET-min/week). Higher score: Reflects the greater the total amount of physical activity an individual has engaged in in the past week. |
| Change in number of finger taps in one minute | Baseline and Week 12 | The change in number of finger taps in one minute of 30 volunteers before and after the intervention was measured. |
Countries
China
Contacts
STUDY_CHAIRLi Jiaomei
Zhejiang Chinese Medical University
Outcome results
None listed