Does Alpha-ketoglutarate Supplementation Lower BiologicaL agE in Middle- Aged Adults?

NCT05706389 | Unknown Phase 2

• 1 other identifier: NUS-IRB-2021-946
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Geroscience is an emerging interdisciplinary field of study in gerontological sciences. With emphasis on understanding the mechanistic drivers of aging, it seeks translational approaches that could eventually be applied to improve human healthspan and delay age-associated chronic diseases. Contrary to popular opinion that aging is irreversible, advances in geroscience research have demonstrated that aging is modifiable and inhibiting or activating specific molecular pathways can improve healthspan and extend lifespan in model organisms. Advocates of geroscience take the view that age-related chronic diseases are best treated by slowing the aging process, rather than using the prevailing disease-centric approach of addressing each disease alone. Thus, the concept is that biological aging, rather than chronological aging, is amenable to intervention. In this regard, geroscientists are at the forefront of longevity medicine in rigorously testing novel supplements, drugs and other prophylactics that can enhance healthspan. Some of these interventions involve repurposing existing drugs such as rapamycin, a well-known immunosuppressant, at different dosing regimens to specifically target biological hallmarks of aging. This study will investigate the effects of alpha-ketoglutarate (AKG), an endogenous metabolite, on biomarkers of aging in middle-aged residents of Singapore.

Conditions

Aging

Keywords

Aging; Geroscience; Alpha-Ketoglutarate; DNA methylation; Healthspan; epigenetic aging clock

Outcome Measures

Primary Outcomes (1)

• Change in blood DNA methylation status, years

  DNA methylation aging clock

  from baseline to end of intervention (6 months)

Secondary Outcomes (34)

• Complete blood count

  from baseline to end of intervention (6 months)

• Carotid-femoral Pulse Wave Velocity change

  from baseline to end of intervention (6 months)

• Central Blood pressure change

  from baseline to end of intervention (6 months)

• Body Mass Index (BMI) change

  from baseline to end of intervention (6 months)

• Brachial Blood pressure change

  from baseline to end of intervention (6 months)

Study Arms (2)

Ca-AKG

EXPERIMENTAL

Pill format, 500mg/pill, half of daily dose

Dietary Supplement: Ca-AKG

Placebo

PLACEBO COMPARATOR

Pill format, indistinguishable from active pill

Dietary Supplement: Ca-AKG

Interventions

Ca-AKG DIETARY_SUPPLEMENT

Eligible participants will be randomised to receive Ca-AKG or Placebo for 6 months.

Ca-AKG; Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• participants whose biological age (as measured by blood DNA methylation) is greater than their chronological age

You may not qualify if:

• pregnant women
• more than ONE of the following chronic medical conditions (based on the medical history and during screening), they are NOT eligible to participate in the study:
• Waist circumference more than or equal to 90 cm for males or more than or equal to 80 cm for females
• Fasting triglycerides more than or equal to 1.7 mmol/l
• High-density lipoprotein less than 1.0 mmol/l in men or less than 1.3 mmol/l in women
• Blood pressure more than or equal to 130/85 mmHg or use of antihypertensive medication
• Fasting glucose more than or equal to 6.0 mmol/l
• Osteopenia
• Mild Osteoarthritis not interfering in daily activities
• Fatty liver
• Participants will NOT be recruited if they fall in the following categories:
• Pre-existing, or history of major CVD (coronary artery disease, heart failure, stroke, peripheral vascular disease, pulmonary hypertension), severe/uncontrolled hypertension (under 3 or more than 3 prescribed medications), rheumatic heart disease, congenital heart disease, deep vein thrombosis, pulmonary embolism
• Type 1 diabetes and Type 2 diabetes under oral metformin or insulin therapy and with diabetic complications such as diabetic retinopathy, diabetic nephropathy
• Active cancer or treatment of cancer in the last 3 years
• Chronic obstructive pulmonary disease (COPD), severe asthma (taking daily medications)

Sponsors & Collaborators

• National University of Singapore: lead
• Agency for Science, Technology and Research: collaborator
• AMILI Pte. Ltd.: collaborator

Study Sites (1)

Centre for Healthy Longevity, Alexandra Hospital

Singapore, 159964, Singapore

RECRUITING

Central Study Contacts

Elena Sandalova, PhD

CONTACT

+6596646302; sanelena@nus.edu.sg

Sangeetha Adiyapatham

CONTACT

+6592391978; sangeetha_adi@visitor.nus.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oon Chiew Seng Professor in Medicine, Healthy Ageing and Dementia Research

Model Details: Double-blinded, placebo-controlled longitudinal interventional study on middle-aged participants

Study Record Dates

• First Submitted: December 25, 2022
• First Posted: January 31, 2023
• Study Start: February 24, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)