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Lo studio clinico NCT07114536 per Invecchiamento è attivo, non in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Evaluation of the Efficacy of Calcium a -Ketoglutarate(AKG-Ca) in Improving Human Aging 30 Randomizzato Doppio cieco Controllato con placebo Dieta
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La sperimentazione clinica NCT07114536 è uno studio interventistico per Invecchiamento, attualmente attivo, non in arruolamento. Avviato il 20 agosto 2025, prevede di arruolare 30 partecipanti. Sotto la guida di Shenzhen Hygieia Biotech Co., Ltd, dovrebbe concludersi entro il 30 gennaio 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 18 novembre 2025.
Sommario breve
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 p...Mostra di più
Titolo ufficiale
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
Patologie
InvecchiamentoPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- Evaluation of AKG-Ca on Aging
Numero NCT
Data di inizio (effettiva)
2025-08-20
Ultimo aggiornamento pubblicato
2025-11-18
Data di completamento (stimata)
2026-01-30
Arruolamento (previsto)
30
Tipo di studio
Interventistico
FASE
N.D.
Stato
Attivo, non in arruolamento
Parole chiave
a-ketoglutaric acid
Phenoage*age
Healthy aging
Phenoage*age
Healthy aging
Scopo principale
Prevenzione
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Quadruplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleIntervention group: calcium-a-ketoglutarate The experimental group subjects took four Ca-AKG tablets (0.5 g/tablet) daily. | Calcium-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 suppl...Mostra di più |
Comparatore placeboControl group: starch Placebo-controlled group subjects took four starch placebo tablets (0.5g/tablet) daily. | Placebo (amido) 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 bli...Mostra di più |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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. | 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 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
40 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
- 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.
- 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).
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1 Centri dello studio in 1 paesi
Zhejiang
Zhejiang Chinese Medicine University, Hangzhou, Zhejiang, 310051, China