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| Name | Class |
|---|---|
| Zhejiang Chinese Medical University | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group: calcium-a-ketoglutarate | Experimental | The experimental group subjects took four Ca-AKG tablets (0.5 g/tablet) daily. |
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| Control group: starch | Placebo Comparator | Placebo-controlled group subjects took four starch placebo tablets (0.5g/tablet) daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gut Microbiota | 16S rRNA sequencing | Baseline, 12-week study |
| Change in Urea (UREA) | The change in Urea (UREA) in mmol/L of 30 volunteers before and after the intervention was measured. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Jiaomei | Zhejiang Chinese Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Chinese Medicine University | Hangzhou | Zhejiang | 310051 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34847066 | Result | 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. | |
| 37217632 |
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Protect volunteers' personal health data and personal privacy.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 13, 2025 | Jul 31, 2025 | Prot_SAP_ICF_000.pdf |
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| 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. |
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| Baseline and Week 12 |
| Change in β-Galactosidase Activity | β-Galactosidase activity will be measured in serum collected at baseline and at Week 12. | 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 | Baseline and Week 12 |
| Change in Grip strength | The change in Grip strength (kg) of 30 volunteers before and after the intervention was 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. | 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. | 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. | 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. | 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. | 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. | Baseline and Week 12 |
| Change in muscle mass | The change in muscle mass (kg) of 30 volunteers before and after the intervention was 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. | 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. | Baseline and 12-week study. |
| Change in protein | The change in protein (kg) of 30 volunteers before and after the intervention was 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and Week 12 |
| Baseline and 12-week study |
| Change in Blood routine test | Blood routine examination indicators | Baseline, 12-week study |
| Change in Total Bilirubin | The change in Total Bilirubin(μmol/L) of 30 volunteers before and after the intervention was measured. | Baseline and 12-week study |
| Changes in SF-36 Questionnaire Scores | 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. | Baseline, 12-week study |
| Change in High-sensitivity C-reactive protein(hs-CRP) | The change in High-sensitivity C-reactive protein(hs-CRP) in mg/L of 30 volunteers before and after the intervention was measured. | Baseline and Week 12 |
| Change in Direct bilirubin | The change in Direct bilirubin(μmol/L) of 30 volunteers before and after the intervention was measured. | Baseline,12-week study |
| Change in Indirect bilirubin | The change in Indirect bilirubinlumol/L) of 30 volunteers before and after the intervention was measured. | Baseline, 12-week study |
| Change in Total bile acid | The change in Total bile acid(μmol/L) of 30 volunteers before and after the intervention was measured. | Baseline,12-week study |
| Change in Albumin | The change in Albumin(g/L) of 30 volunteers before and after the intervention was measured. | Baseline, 12-week study |
| Change in Globulin | The change in Globulin(g/L) of 30 volunteers before and after the intervention was measured. | Baseline,12-week study |
| Change in tumour necrosis factor (TNF-a) | The change in tumour necrosis factor (TNF-a) in pg/mL of 30 volunteers before and after the intervention was measured. | Baseline and 12-week study |
| Change in interleukin-2 (lL-2) | The change in interleukin-2 (lL-2) in pg/mL of 30 volunteers before and after the intervention was measured. | Baseline and 12-week study |
| Change in Interleukin-6 | The change in Interleukin-6 (lL-6) in pg/mL of 30 volunteers before and after the intervention was measured. | Baseline and 12-week study |
| Change in Interleukin-8 (lL-8) | The change in Interleukin-8 (lL-8) in pg/mL of 30 volunteers before and after the intervention was measured. | Baseline and 12-week study |
| Change in interleukin-10 (lL-10) | The change in interleukin-10 (lL-10) in pg/mL of 30 volunteers before and after the intervention was measured. | Baseline and 12-week study |
| Result |
| Sandalova 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. |
| 30596641 | Result | Liu 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. |
| 38740004 | Result | Liu 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. |