NCT07500649

Brief Summary

The global ageing population is increasingly affected by age-related diseases, which are challenging healthcare systems. Current treatments often extend lifespan without improving healthspan. The geroscience hypothesis suggests that targeting the ageing process could prevent or delay multiple diseases, enhancing healthspan. Fucoidan, a sulfated polysaccharide from brown macroalgae, is a safe dietary supplement with Sirtuin-6 (SIRT6) activating properties, which are linked to longevity. Clinical studies have shown that it reduces inflammatory markers associated with biological aging and frailty and influences DNA methylation in vitro and in vivo; however, its effects on human DNA methylation remain unknown.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Jul 2025Dec 2027

Study Start

First participant enrolled

July 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

February 10, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

AgingGeroscienceFucoidanSIRT6 ActivatorDNA methylationHealthspanEpigenetic 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 (33)

  • Change in blood inflammatory markers (pg/mL)

    from baseline to end of intervention (6 months)

  • Body Mass Index (BMI) change

    from baseline to end of intervention (6 months)

  • Waist-to-hip ratio change

    from baseline to end of intervention (6 months)

  • Body fat mass (kg) change

    from baseline to end of intervention (6 months)

  • Skeletal muscle mass (kg) change

    from baseline to end of intervention (6 months)

  • +28 more secondary outcomes

Study Arms (2)

SIRT6 activator

EXPERIMENTAL

Participants in this arm will take 2.4 g/day of Fucoidan (or known as SIRT6 activator) supplement for 6 months

Dietary Supplement: Fucoidan

Placebo

PLACEBO COMPARATOR

Participants in this arm will take 2.4 g/day of placebo for 6 months

Dietary Supplement: Placebo

Interventions

PlaceboDIETARY_SUPPLEMENT

Eligible participants will be randomized to receive SIRT6 Activator (fucoidan) or Placebo for 6 months.

Placebo
FucoidanDIETARY_SUPPLEMENT

Eligible participants will be randomized to receive SIRT6 Activator (fucoidan) or Placebo for 6 months.

SIRT6 activator

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years males;
  • Resident of Singapore (citizenship or permanent residency is not required);
  • Prefrail according to Fried frailty phenotype score;
  • English-literate who can understand, read and write in English;
  • Individuals without severe cognitive impairment, as determined by PI judgment;
  • Apparently healthy and non-smokers having not more than 2 of the following conditions. If the conditions are present they have to be stable:
  • Hypertension,
  • Hyperlipidemia,
  • Hyperglycemia,
  • Osteopenia/osteoporosis,
  • Osteoarthritis,
  • COPD,
  • Type 2 diabetes.
  • Subjects who agree to shave one day before each visit if he has dense facial hairs on their cheeks that could interfere with skin microbiome sampling.

You may not qualify if:

  • Pre-existing or history of major cardiovascular disease (e.g., coronary artery disease, heart failure, stroke, peripheral vascular disease);
  • Current cancer or non-stable chronic obstructive pulmonary disease (COPD);
  • Use of anticoagulant medication;
  • Consuming seaweed more than 3 times a week;
  • Having hairiness, moles, tattoos, scars, irritated skin, etc. on the face which could influence the investigation;
  • Having used within the 3 past weeks for more than 3 consecutive days any systemic or topical drugs related to antibiotics or having planned to use these treatments during the study;
  • Having a positive serology for HIV, HEPATITIS B, HEPATITIS C\*
  • \*Subjects will undergo a serology test, which will be conducted at baseline and at the end of the intervention visit. Only for subjects who accepted to undergo skin microbiopsy sampling;
  • Subject with any contra-indication for skin microbiopsies:
  • hypersensitivity or any serious reaction to local anesthesia; (lidocaine/prilocaine), local antibiotics, and antiseptics,
  • with inherited or acquired hemostasis disorders,
  • having had any treatment which may affect the blood coagulation and hemostasis (anti-coagulant medications…),
  • having a history of wound healing defects (hypertrophic scars, keloids…).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yong Loo Lin School of Medicine, National University of Singapore

Singapore, Singapore, 117597, Singapore

RECRUITING

NUS Academy for Healthy Longevity, Level 6, MD 11, 10 Medical Dr, Yong Loo Lin School of Medicine, National University of Singapore

Singapore, Singapore

NOT YET RECRUITING

MeSH Terms

Interventions

fucoidan

Central Study Contacts

Andrea Britta Maier, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oon Chiew Seng Professor in Medicine, Healthy Ageing and Dementia Research

Study Record Dates

First Submitted

February 10, 2026

First Posted

March 30, 2026

Study Start

July 1, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations