NVTIA® Ergothioneine for Healthy Aging and Skin Health

NCT07750002 | Recruiting

• 1 other identifier: HCT-54749
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Aging; Skin Aging; Oxidative Stress

Outcome Measures

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.

  Baseline and Week 12

Secondary Outcomes (5)

• Change in Skin Elasticity

  Baseline and Week 12

• Change in Malondialdehyde (MDA)

  Baseline and Week 12

• Change in High-sensitivity C-reactive Protein (hs-CRP)

  Baseline and Week 12

• Change in Interleukin-6 (IL-6)

  Baseline and Week 12

• Incidence of Adverse Events

  Throughout the 12-week study

Study Arms (2)

NVTIA® Ergothioneine

EXPERIMENTAL

Participants will receive capsules containing NVTIA® Ergothioneine, providing 30 mg ergothioneine once daily for 12 weeks.

Dietary Supplement: NVTIA® Ergothioneine

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo capsules identical in appearance to the investigational product once daily for 12 weeks.

Other: Placebo

Interventions

NVTIA® Ergothioneine DIETARY_SUPPLEMENT

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

NVTIA® Ergothioneine

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EUROPEAN LIFE SCIENCE RESEARCH ASSOCIATION: lead

Study Sites (1)

Dhaka Central International Medical College & Hospital

Dhaka, Bangladesh

RECRUITING

Related Publications (5)

• Tian X, Thorne JL, Moore JB. Ergothioneine: an underrecognised dietary micronutrient required for healthy ageing? Br J Nutr. 2023 Jan 14;129(1):104-114. doi: 10.1017/S0007114522003592.

  PMID: 38018890 BACKGROUND

• Borodina I, Kenny LC, McCarthy CM, Paramasivan K, Pretorius E, Roberts TJ, van der Hoek SA, Kell DB. The biology of ergothioneine, an antioxidant nutraceutical. Nutr Res Rev. 2020 Dec;33(2):190-217. doi: 10.1017/S0954422419000301. Epub 2020 Feb 13.

  PMID: 32051057 BACKGROUND

• Halliwell B, Cheah IK, Drum CL. Ergothioneine, an adaptive antioxidant for the protection of injured tissues? A hypothesis. Biochem Biophys Res Commun. 2016 Feb 5;470(2):245-250. doi: 10.1016/j.bbrc.2015.12.124. Epub 2016 Jan 6.

  PMID: 26772879 BACKGROUND

• Cheah IK, Halliwell B. Ergothioneine; antioxidant potential, physiological function and role in disease. Biochim Biophys Acta. 2012 May;1822(5):784-93. doi: 10.1016/j.bbadis.2011.09.017. Epub 2011 Oct 4.

  PMID: 22001064 BACKGROUND

• Paul BD, Snyder SH. The unusual amino acid L-ergothioneine is a physiologic cytoprotectant. Cell Death Differ. 2010 Jul;17(7):1134-40. doi: 10.1038/cdd.2009.163. Epub 2009 Nov 13.

  PMID: 19911007 BACKGROUND

MeSH Terms

Interventions

Ergothioneine

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Histidine; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Daniel Harris

CONTACT

+880 1712 345678; work.director@dcimch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 6, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): April 8, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)