Evaluation of the Efficacy of Calcium a -Ketoglutarate(AKG-Ca) in Improving Human Aging

Not Applicable

Not yet recruiting

• Conditions: Aging

• Registration Number: NCT07114536
• Lead Sponsor: Shenzhen Hygieia Biotech Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-31
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-06
• Study First Posted: 2025-08-11
• Last Update Submitted: 2025-08-14
• Study Start: 2025-08-20
• Last Update Posted: 2025-08-20
• Primary Completion: 2026-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Xinhua Hospital of Zhejiang Province; 🇨🇳 Hangzhou, Zhejiang, China