NVTIA® Ergothioneine for Healthy Aging and Skin Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-55
SponsorEUROPEAN LIFE SCIENCE RESEARCH ASSOCIATION
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
NVTIA® Ergothioneine
Dietary supplementNVTIA® Ergothioneine is a standardized branded ergothioneine ingredient manufactured under controlled quality standards for use as a dietary supplement.
Placebo
Other interventionMatching placebo capsules identical in appearance, color, size, and packaging to the investigational product. One capsule will be administered orally once daily for 12 weeks.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: NVTIA® ErgothioneineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 12Secondary outcomes
1
Change in Skin Elasticity
Assessment of skin elasticity using an objective skin measurement device.
Time frame
Baseline and Week 122
Change in Malondialdehyde (MDA)
Evaluation of changes in plasma malondialdehyde concentrations.
Time frame
Baseline and Week 123
Change in High-sensitivity C-reactive Protein (hs-CRP)
Evaluation of changes in serum hs-CRP concentrations.
Time frame
Baseline and Week 124
Change in Interleukin-6 (IL-6)
Evaluation of changes in serum IL-6 concentrations.
Time frame
Baseline and Week 12Sponsors and contacts
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Source ClinicalTrials.gov