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NCT Number: NCT07114536

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aging

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Chinese Medicine University

Hangzhou, Zhejiang, 310051, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Calcium-a-ketoglutarate

Dietary Supplement

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.

Placebo(starch)

Other

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.

Primary outcomes

  1. Change in PhenoAge from Baseline to Week 12

    Time frame: 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 outcomes

  1. Change in Calcium Content of Bone

    Time frame: 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.

  2. Change in β-Galactosidase Activity

    Time frame: Baseline and Week 12

    β-Galactosidase activity will be measured in serum collected at baseline and at Week 12.

  3. Change in Age-related Gene Expression

    Time frame: 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

  4. Change in Grip strength

    Time frame: Baseline,12-week study

    The change in Grip strength (kg) of 30 volunteers before and after the intervention was measured.

  5. Change in body Weight

    Time frame: Baseline and Week 12

    The change in body weight (kg) of 30 volunteers before and after the intervention was measured.

  6. Change in body mass index(BMl)

    Time frame: Baseline and Week 12

    The change in Body Mass Index (BMl) kg/m2 of 30 volunteers before and after the intervention was measured.

  7. Change in body fat mass

    Time frame: Baseline and Week 12

    The change in body fat mass(kg) of 30 volunteers before and after the intervention was measured.

  8. Change in alkaline phosphatase (ALP)

    Time frame: Baseline and Week 12

    The change in alkaline phosphatase (ALP) in U/L of 30 volunteers before and after the intervention was measured.

  9. Change in body fat percentage

    Time frame: Baseline and Week 12

    The change in body fat percentage (%) of 30 volunteers before and after the intervention was measured.

  10. Change in fat-free mass

    Time frame: Baseline and Week 12

    The change in fat-free mass(kg) of 30 volunteers before and after the intervention was measured.

  11. Change in muscle mass

    Time frame: Baseline and Week 12

    The change in muscle mass (kg) of 30 volunteers before and after the intervention was measured.

  12. Change in body water

    Time frame: Baseline and Week 12

    The change in body water (kg) of 30 volunteers before and after the intervention was measured.

  13. Change in blood creatinine (CREA)

    Time frame: Baseline and 12-week study.

    The change in blood creatinine (CREA) in mol/L of 30 volunteers before and after the intervention was measured.

  14. Change in protein

    Time frame: Baseline and Week 12

    The change in protein (kg) of 30 volunteers before and after the intervention was measured.

  15. Change in inorganic salts

    Time frame: Baseline and Week 12

    The change in inorganic salts (kg) of 30 volunteers before and after the intervention was measured.

  16. Change in TotalT lymphocytes (CD3+)

    Time frame: Baseline and Week 12

    The change in TotalT lymphocytes (CD3+) (cells/μl) of 30 volunteers before and after the intervention was measured.

  17. Change in helper T cells(cD4+)

    Time frame: Baseline and Week 12

    The change in helper T cells (CD4+) (cells/μl) of 30 volunteers before and after the intervention was measured.

  18. Change in cytotoxicT cells(CD8+)

    Time frame: Baseline and Week 12

    The change in cytotoxic T cells (CD8+)(cells/μL) of 30 volunteers before and after the intervention was measured.

  19. Change in Glycated haemoglobin (HbAlc)

    Time frame: Baseline and Week 12

    The change in Glycated haemoglobin (HbA1c) (%) of 30 volunteers before and after the intervention was measured.

  20. Change in Fasting blood glucose

    Time frame: Baseline and Week 12

    The change in Fasting blood glucose (mmol/L) of 30 volunteers before and after the intervention was measured.

  21. Change in Fasting insulin

    Time frame: Baseline and Week 12

    The change in Fasting insulin (pmol/L) of 30 volunteers before and after the intervention was measured.

  22. Change in Physical activity questionnaire Scores

    Time frame: 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.

  23. Change in number of finger taps in one minute

    Time frame: Baseline and Week 12

    The change in number of finger taps in one minute of 30 volunteers before and after the intervention was measured.

Other outcomes

  1. Change in Gut Microbiota

    Time frame: Baseline, 12-week study

    16S rRNA sequencing

  2. Change in Urea (UREA)

    Time frame: Baseline and 12-week study

    The change in Urea (UREA) in mmol/L of 30 volunteers before and after the intervention was measured.

  3. Change in Blood routine test

    Time frame: Baseline, 12-week study

    Blood routine examination indicators

  4. Change in Total Bilirubin

    Time frame: Baseline and 12-week study

    The change in Total Bilirubin(μmol/L) of 30 volunteers before and after the intervention was measured.

  5. Changes in SF-36 Questionnaire Scores

    Time frame: Baseline, 12-week study

    36-Item Short Form Health Survey. At baseline and 12 weeks, measure changes in participants' SF-36 questionnaire scores. The score range for each dimension of the SF-36 questionnaire is 0~100 points, with 0 representing the worst health status in the dimension and 100 representing the best. The composite score (PCS and MCS) is a mean of 50, and the higher the score, the better the physical or mental health, such as strong physical function and emotional stability; Lower scores indicate more serious health problems, such as pain, functional limitations, or psychological distress.

  6. Change in High-sensitivity C-reactive protein(hs-CRP)

    Time frame: Baseline and Week 12

    The change in High-sensitivity C-reactive protein(hs-CRP) in mg/L of 30 volunteers before and after the intervention was measured.

  7. Change in Direct bilirubin

    Time frame: Baseline,12-week study

    The change in Direct bilirubin(μmol/L) of 30 volunteers before and after the intervention was measured.

  8. Change in Indirect bilirubin

    Time frame: Baseline, 12-week study

    The change in Indirect bilirubinlumol/L) of 30 volunteers before and after the intervention was measured.

  9. Change in Total bile acid

    Time frame: Baseline,12-week study

    The change in Total bile acid(μmol/L) of 30 volunteers before and after the intervention was measured.

  10. Change in Albumin

    Time frame: Baseline, 12-week study

    The change in Albumin(g/L) of 30 volunteers before and after the intervention was measured.

  11. Change in Globulin

    Time frame: Baseline,12-week study

    The change in Globulin(g/L) of 30 volunteers before and after the intervention was measured.

  12. Change in tumour necrosis factor (TNF-a)

    Time frame: Baseline and 12-week study

    The change in tumour necrosis factor (TNF-a) in pg/mL of 30 volunteers before and after the intervention was measured.

  13. Change in interleukin-2 (lL-2)

    Time frame: Baseline and 12-week study

    The change in interleukin-2 (lL-2) in pg/mL of 30 volunteers before and after the intervention was measured.

  14. Change in Interleukin-6

    Time frame: Baseline and 12-week study

    The change in Interleukin-6 (lL-6) in pg/mL of 30 volunteers before and after the intervention was measured.

  15. Change in Interleukin-8 (lL-8)

    Time frame: Baseline and 12-week study

    The change in Interleukin-8 (lL-8) in pg/mL of 30 volunteers before and after the intervention was measured.

  16. Change in interleukin-10 (lL-10)

    Time frame: Baseline and 12-week study

    The change in interleukin-10 (lL-10) in pg/mL of 30 volunteers before and after the intervention was measured.

Sponsors and collaborators

Lead sponsor

Shenzhen Hygieia Biotech Co., Ltd

Industry

Collaborators

  • Zhejiang Chinese Medical University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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