AgingNCT07114536
Evaluation of the Efficacy of Calcium a -Ketoglutarate(AKG-Ca) in Improving Human Aging
A study testing Calcium-a-ketoglutarate in people with Aging, run by Shenzhen Hygieia Biotech Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Calcium-a-ketoglutarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Aging
- Being tested
- Calcium-a-ketoglutarate, Placebo(starch)
- Keywords
- a-ketoglutaric acid, Phenoage*age, Healthy aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium-a-ketoglutarateDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: calcium-a-ketoglutarate | Experimental | The experimental group subjects took four Ca-AKG tablets (0.5 g/tablet) daily. Receives: Dietary Supplement: Calcium-a-ketoglutarate |
| Control group: starch | Placebo comparator | Placebo-controlled group subjects took four starch placebo tablets (0.5g/tablet) daily. Receives: Other: Placebo(starch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PhenoAge from Baseline to 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.
Measured: Baseline and Week 12
Secondary outcomes (23)
Change in Calcium Content of Bone
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.
Measured: Baseline and Week 12
Change in β-Galactosidase Activity
β-Galactosidase activity will be measured in serum collected at baseline and at Week 12.
Measured: Baseline and Week 12
Change in Age-related Gene Expression
e.g., SIRT1~7、TERT/TERC、p21(CDKN1A)、p16INK4a(CDKN2A)、PDGFRB、PLOD1、MAP4K4、NFKBIA、GFAP、F2RL3、HERPUD1、PPPIR15A、PCBP1、TFAM、MMP7
Measured: Baseline and Week 12
Change in Grip strength
The change in Grip strength (kg) of 30 volunteers before and after the intervention was measured.
Measured: Baseline,12-week study
Change in body Weight
The change in body weight (kg) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in body mass index(BMl)
The change in Body Mass Index (BMl) kg/m2 of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in body fat mass
The change in body fat mass(kg) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in alkaline phosphatase (ALP)
The change in alkaline phosphatase (ALP) in U/L of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in body fat percentage
The change in body fat percentage (%) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in fat-free mass
The change in fat-free mass(kg) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in muscle mass
The change in muscle mass (kg) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in body water
The change in body water (kg) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in blood creatinine (CREA)
The change in blood creatinine (CREA) in mol/L of 30 volunteers before and after the intervention was measured.
Measured: Baseline and 12-week study.
Change in protein
The change in protein (kg) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in inorganic salts
The change in inorganic salts (kg) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in TotalT lymphocytes (CD3+)
The change in TotalT lymphocytes (CD3+) (cells/μl) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in helper T cells(cD4+)
The change in helper T cells (CD4+) (cells/μl) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in cytotoxicT cells(CD8+)
The change in cytotoxic T cells (CD8+)(cells/μL) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in Glycated haemoglobin (HbAlc)
The change in Glycated haemoglobin (HbA1c) (%) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in Fasting blood glucose
The change in Fasting blood glucose (mmol/L) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in Fasting insulin
The change in Fasting insulin (pmol/L) of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Change in Physical activity questionnaire Scores
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.
Measured: Baseline and Week 12
Change in number of finger taps in one minute
The change in number of finger taps in one minute of 30 volunteers before and after the intervention was measured.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start20 Aug 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hygieia Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang Chinese Medical University
- Responsible party
- Sponsor
- Investigators
- Li Jiaomei, Study chair, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114536
- Sponsor's protocol ID
- Evaluation of AKG-Ca on Aging
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protect volunteers' personal health data and personal privacy.
Publications
Demidenko O, Barardo D, Budovskii V, Finnemore R, Palmer FR, Kennedy BK, Budovskaya YV. Rejuvant(R), a potential life-extending compound formulation with alpha-ketoglutarate and vitamins, conferred an average 8 year reduction in biological aging, after an average of 7 months of use, in the TruAge DNA methylation test. Aging (Albany NY). 2021 Nov 30;13(22):24485-24499. doi: 10.18632/aging.203736. Epub 2021 Nov 30.
PubMed 34847066Sandalova E, Goh J, Lim ZX, Lim ZM, Barardo D, Dorajoo R, Kennedy BK, Maier AB. Alpha-ketoglutarate supplementation and BiologicaL agE in middle-aged adults (ABLE)-intervention study protocol. Geroscience. 2023 Oct;45(5):2897-2907. doi: 10.1007/s11357-023-00813-6. Epub 2023 May 23.
PubMed 37217632Liu Z, Kuo PL, Horvath S, Crimmins E, Ferrucci L, Levine M. A new aging measure captures morbidity and mortality risk across diverse subpopulations from NHANES IV: A cohort study. PLoS Med. 2018 Dec 31;15(12):e1002718. doi: 10.1371/journal.pmed.1002718. eCollection 2018 Dec.
PubMed 30596641Liu C, Hua L, Xin Z. Synergistic impact of 25-hydroxyvitamin D concentrations and physical activity on delaying aging. Redox Biol. 2024 Jul;73:103188. doi: 10.1016/j.redox.2024.103188. Epub 2024 May 10.
PubMed 38740004
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07114536
- Acronym / sponsor ID
- Evaluation of AKG-Ca on Aging
- Conditions
- Aging
- Keywords
- a-ketoglutaric acid, Phenoage*age, Healthy aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Shenzhen Hygieia Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Zhejiang Chinese Medical University
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: calcium-a-ketoglutarate | Experimental | Dietary Supplement: Calcium-a-ketoglutarateThe experimental group subjects took four Ca-AKG tablets (0.5 g/tablet) daily. |
| Control group: starch | Placebo comparator | Other: Placebo(starch)Placebo-controlled group subjects took four starch placebo tablets (0.5g/tablet) daily. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium-a-ketoglutarateDescription: 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. | Dietary supplement | Intervention group: calcium-a-ketoglutarate |
| Placebo(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. | Other | Control group: starch |
Primary outcome
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.
23 secondary outcomes
Change in Calcium Content of Bone
Time frame: Baseline and Week 12
Change in β-Galactosidase Activity
Time frame: Baseline and Week 12
Change in Age-related Gene Expression
Time frame: Baseline and Week 12
Change in Grip strength
Time frame: Baseline,12-week study
Change in body Weight
Time frame: Baseline and Week 12
Change in body mass index(BMl)
Time frame: Baseline and Week 12
Change in body fat mass
Time frame: Baseline and Week 12
Change in alkaline phosphatase (ALP)
Time frame: Baseline and Week 12
Change in body fat percentage
Time frame: Baseline and Week 12
Change in fat-free mass
Time frame: Baseline and Week 12
Change in muscle mass
Time frame: Baseline and Week 12
Change in body water
Time frame: Baseline and Week 12
Change in blood creatinine (CREA)
Time frame: Baseline and 12-week study.
Change in protein
Time frame: Baseline and Week 12
Change in inorganic salts
Time frame: Baseline and Week 12
Change in TotalT lymphocytes (CD3+)
Time frame: Baseline and Week 12
Change in helper T cells(cD4+)
Time frame: Baseline and Week 12
Change in cytotoxicT cells(CD8+)
Time frame: Baseline and Week 12
Change in Glycated haemoglobin (HbAlc)
Time frame: Baseline and Week 12
Change in Fasting blood glucose
Time frame: Baseline and Week 12
Change in Fasting insulin
Time frame: Baseline and Week 12
Change in Physical activity questionnaire Scores
Time frame: Baseline and Week 12
Change in number of finger taps in one minute
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Results publication: PubMed 34847066Demidenko O, Barardo D, Budovskii V, Finnemore R, Palmer FR, Kennedy BK, Budovskaya YV. Rejuvant(R), a potential life-extending compound formulation with alpha-ketoglutarate and vitamins, conferred an average 8 year reduction in biological aging, after an average of 7 months of use, in the TruAge DNA methylation test. Aging (Albany NY). 2021 Nov 30;13(22):24485-24499. doi: 10.18632/aging.203736. Epub 2021 Nov 30.
- Results publication: PubMed 37217632Sandalova E, Goh J, Lim ZX, Lim ZM, Barardo D, Dorajoo R, Kennedy BK, Maier AB. Alpha-ketoglutarate supplementation and BiologicaL agE in middle-aged adults (ABLE)-intervention study protocol. Geroscience. 2023 Oct;45(5):2897-2907. doi: 10.1007/s11357-023-00813-6. Epub 2023 May 23.
- Results publication: PubMed 30596641Liu Z, Kuo PL, Horvath S, Crimmins E, Ferrucci L, Levine M. A new aging measure captures morbidity and mortality risk across diverse subpopulations from NHANES IV: A cohort study. PLoS Med. 2018 Dec 31;15(12):e1002718. doi: 10.1371/journal.pmed.1002718. eCollection 2018 Dec.
- Results publication: PubMed 38740004Liu C, Hua L, Xin Z. Synergistic impact of 25-hydroxyvitamin D concentrations and physical activity on delaying aging. Redox Biol. 2024 Jul;73:103188. doi: 10.1016/j.redox.2024.103188. Epub 2024 May 10.
- Individual participant dataSharing planned: No. Protect volunteers' personal health data and personal privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Jiaomei study chair
Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium-a-ketoglutarate in people with Aging, run by Shenzhen Hygieia Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PhenoAge from Baseline to Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07114536, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.