Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Participants must meet all of the following criteria:
- Male or female adults aged 35 to 55 years.
- Generally healthy as determined by medical history, physical examination, and screening assessments.
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
- Willing and able to provide written informed consent.
- Willing to maintain their usual diet, physical activity, and lifestyle throughout the study period.
- Willing to avoid the use of other antioxidant, anti-aging, or nutritional supplements during the study period unless approved by the investigator.
- Able and willing to comply with all study procedures and scheduled visits.
Exclusion Criteria:
- Participants meeting any of the following criteria will be excluded:
- History of clinically significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, neurological, or psychiatric disease.
- Current diagnosis of diabetes mellitus requiring medication.
- Active inflammatory or autoimmune disease.
- History of malignant disease within the previous five years.
- Pregnancy, breastfeeding, or planning pregnancy during the study period.
- Known allergy or hypersensitivity to ergothioneine or any ingredient of the study product.
- Use of antioxidant supplements, anti-aging supplements, or investigational products within 30 days before enrollment.
- Current smoker or history of heavy alcohol consumption.
- Participation in another clinical trial within the previous 30 days.
- Any medical condition or laboratory abnormality that, in the opinion of the investigator, may interfere with study participation or interpretation of study results.
