Dhaka Central International Medical College & Hospital
Dhaka, Bangladesh
Location status: Recruiting
NCT Number: NCT07750002
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.
Interested in participating?
Request Info35 year–55 year
All sexes
Interventional
Not applicable
Dhaka, Bangladesh
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NVTIA® Ergothioneine is a standardized branded ergothioneine ingredient manufactured under controlled quality standards for use as a dietary supplement.
Other names: 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.
Time frame: Baseline and Week 12
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
Assessment of skin elasticity using an objective skin measurement device.
Time frame: Baseline and Week 12
Evaluation of changes in plasma malondialdehyde concentrations.
Time frame: Baseline and Week 12
Evaluation of changes in serum hs-CRP concentrations.
Time frame: Baseline and Week 12
Evaluation of changes in serum IL-6 concentrations.
Time frame: Throughout the 12-week study
Number and severity of treatment-emergent adverse events during the study.
Contact information is provided by the study sponsor or research team.
EUROPEAN LIFE SCIENCE RESEARCH ASSOCIATION
Other
A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effects of NVTIA® Ergothioneine Supplementation on Healthy Aging Biomarkers and Skin Health in Healthy Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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