Fucoidan SIRT6 activator for healthy aging in prefrail older men

SIRT6 Activation to Improve Biological Age Measured by GrimAge in Pre-frail, Middle-aged to Older Men: a Randomized Controlled Trial

This trial will test whether a fucoidan supplement that activates SIRT6 can change biological aging markers in prefrail men aged 50–80.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 50 Years to 80 Years
• Sex: Male
• Sponsor: National University of Singapore (other)
• Locations: 2 sites (Singapore, Singapore and 1 other locations)
• Trial ID: NCT07500649 on ClinicalTrials.gov

What this trial studies

This is an interventional, placebo-controlled study testing oral fucoidan, a SIRT6-activating supplement, in prefrail men aged 50–80 living in Singapore. Participants will receive fucoidan or placebo and undergo measurements of inflammatory markers, DNA methylation profiles, and other aging-related biomarkers, with some skin microbiome sampling that may require shaving prior to visits. The protocol enrolls English-literate, non-smoking males without major cardiovascular disease and allows up to two stable chronic conditions from a specified list. The study builds on preclinical and small clinical signals linking fucoidan to reduced inflammation and epigenetic modulation but directly examines effects on human DNA methylation and biological aging markers.

Who should consider this trial

Good fit: Men aged 50–80 who live in Singapore, are prefrail by the Fried phenotype, English-literate, non-smokers, without severe cognitive impairment, and with no major cardiovascular disease are ideal candidates.

Not a fit: People with major cardiovascular disease, active cancer, non-stable COPD, severe cognitive impairment, women, or those outside the age or residency criteria are unlikely to be eligible or to directly benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce inflammatory and epigenetic markers of biological aging and potentially improve healthspan in prefrail older men.

How similar studies have performed: Small open-label clinical work and preclinical studies have shown fucoidan can lower inflammatory cytokines and modulate DNA methylation in vitro and in vivo, but robust human DNA methylation effects remain unproven.

Eligibility criteria

Inclusion Criteria:

1. 50-80 years males;
2. Resident of Singapore (citizenship or permanent residency is not required);
3. Prefrail according to Fried frailty phenotype score;
4. English-literate who can understand, read and write in English;
5. Individuals without severe cognitive impairment, as determined by PI judgment;
6. 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.

Exclusion Criteria:

1. Pre-existing or history of major cardiovascular disease (e.g., coronary artery disease, heart failure, stroke, peripheral vascular disease);
2. Current cancer or non-stable chronic obstructive pulmonary disease (COPD);
3. Use of anticoagulant medication;
4. Consuming seaweed more than 3 times a week;
5. Having hairiness, moles, tattoos, scars, irritated skin, etc. on the face which could influence the investigation;
6. 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;
7. 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;
8. 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…).

Where this trial is running

Singapore, Singapore and 1 other locations

• Yong Loo Lin School of Medicine, National University of Singapore — Singapore, Singapore, 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)

Study contacts

• Study coordinator: Andrea Britta Maier, MD PhD

Conditions: Aging, Geroscience, Fucoidan, SIRT6 Activator, DNA methylation, Healthspan, Epigenetic aging clock