An interventional study of NVTIA® Ergothioneine and Placebo in Healthy Aging, Skin Aging and Oxidative Stress, sponsored by EUROPEAN LIFE SCIENCE RESEARCH ASSOCIATION. Recruiting at 1 site in Bangladesh. Open to participants aged 35 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by EUROPEAN LIFE SCIENCE RESEARCH ASSOCIATION · Not applicable, Interventional, and Prevention
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of NVTIA® Ergothioneine, a branded ergothioneine ingredient, on healthy aging biomarkers and skin health in healthy adults aged 40 to 65 years. Participants will receive either NVTIA® Ergothioneine or a matching placebo once daily for 12 weeks.
The primary objective of this study is to evaluate the effects of NVTIA® Ergothioneine supplementation on biomarkers associated with oxidative stress and healthy aging. Secondary objectives include assessment of skin elasticity, skin hydration, inflammatory biomarkers, and overall safety. The findings of this study are expected to provide clinical evidence supporting the role of NVTIA® Ergothioneine in promoting healthy aging and maintaining skin health.
Healthy aging has become an important public health objective because of the increasing global aging population. Aging is associated with progressive accumulation of oxidative stress, chronic low-grade inflammation, and gradual decline in cellular function. These biological changes contribute to deterioration of skin condition, reduced physiological resilience, and increased susceptibility to age-related disorders.
NVTIA® Ergothioneine is a branded ergothioneine ingredient manufactured under standardized production conditions and intended for use as a dietary supplement ingredient. Ergothioneine is a naturally occurring sulfur-containing amino acid derivative that is actively transported into human tissues through the Organic Cation Transporter Novel Type 1 (OCTN1), allowing preferential accumulation in tissues exposed to oxidative stress. Experimental studies have demonstrated antioxidant, cytoprotective, and anti-inflammatory properties of ergothioneine, suggesting its potential role in supporting healthy aging.
Although preclinical and observational studies have suggested potential health benefits of ergothioneine, well-designed randomized controlled clinical trials evaluating the effects of a standardized branded ergothioneine ingredient on healthy aging biomarkers remain limited.
The present study is designed to generate high-quality clinical evidence regarding the effects of NVTIA® Ergothioneine supplementation on biomarkers associated with healthy aging and skin health in healthy adults. The findings are expected to support scientific understanding of ergothioneine supplementation and provide evidence for the use of NVTIA® Ergothioneine as a standardized dietary supplement ingredient.
This is the only study on the registry with EUROPEAN LIFE SCIENCE RESEARCH ASSOCIATION as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive capsules containing NVTIA® Ergothioneine, providing 30 mg ergothioneine once daily for 12 weeks.
Dietary Supplement: NVTIA® Ergothioneine
Participants will receive matching placebo capsules identical in appearance to the investigational product once daily for 12 weeks.
Other: Placebo
NVTIA® Ergothioneine is a standardized branded ergothioneine ingredient manufactured under controlled quality standards for use as a dietary supplement.
Also known as: Ergothioneine, L-Ergothioneine
Matching placebo capsules identical in appearance, color, size, and packaging to the investigational product. One capsule will be administered orally once daily for 12 weeks.
Change in Plasma 8-Hydroxy-2'-deoxyguanosine (8-OHdG)
To evaluate the change in plasma 8-Hydroxy-2'-deoxyguanosine (8-OHdG) concentrations from baseline following 12 weeks of NVTIA® Ergothioneine supplementation.
Time frame: Baseline and Week 12
Change in Skin Elasticity
Assessment of skin elasticity using an objective skin measurement device.
Time frame: Baseline and Week 12
Change in Malondialdehyde (MDA)
Evaluation of changes in plasma malondialdehyde concentrations.
Time frame: Baseline and Week 12
Change in High-sensitivity C-reactive Protein (hs-CRP)
Evaluation of changes in serum hs-CRP concentrations.
Time frame: Baseline and Week 12
Change in Interleukin-6 (IL-6)
Evaluation of changes in serum IL-6 concentrations.
Time frame: Baseline and Week 12
Incidence of Adverse Events
Number and severity of treatment-emergent adverse events during the study.
Time frame: Throughout the 12-week study
Plan to share: No — Individual participant data will not be made publicly available to protect participant confidentiality and proprietary research information.
Start is estimated for Aug 2026; primary completion for Oct 2026, 2 months later.
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Studies of the drug tested here: Ergothioneine