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

Shenzhen Hygieia Biotech Co., Ltd

Status: Active, not recruiting

Conditions: Aging

Treatments: Dietary Supplement: Calcium-a-ketoglutarate; Other: Placebo(starch)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07114536

Evaluation of AKG-Ca on Aging

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Intervention group: calcium-a-ketoglutarate

Experimental group

Description:

The experimental group subjects took four Ca-AKG tablets (0.5 g/tablet) daily.

Treatment:

Dietary Supplement: Calcium-a-ketoglutarate

Control group: starch

Placebo Comparator group

Description:

Placebo-controlled group subjects took four starch placebo tablets (0.5g/tablet) daily.

Treatment:

Other: Placebo(starch)