Healthy AgingNCT07750002
NVTIA® Ergothioneine for Healthy Aging and Skin Health
A study testing NVTIA® Ergothioneine in people with Healthy Aging and Skin Aging, run by EUROPEAN LIFE SCIENCE RESEARCH ASSOCIATION at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Skin Aging, Oxidative Stress
- What is being tested?
- NVTIA® Ergothioneine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBangladesh
- Study dates
- 15 Aug 2026to 8 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Dhaka Central International Medical College & Hospital
Dhaka
Daniel Harris, +880 1712 345678, director-@dcimch.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effects of NVTIA® Ergothioneine Supplementation on Healthy Aging Biomarkers and Skin Health in Healthy Adults
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.
Read the detailed 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.
- Conditions
- Healthy Aging, Skin Aging, Oxidative Stress
- Being tested
- NVTIA® Ergothioneine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVTIA® ErgothioneineDietary supplement
Also called Ergothioneine, L-Ergothioneine
NVTIA® Ergothioneine is a standardized branded ergothioneine ingredient manufactured under controlled quality standards for use as a dietary supplement.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NVTIA® Ergothioneine | Experimental | Participants will receive capsules containing NVTIA® Ergothioneine, providing 30 mg ergothioneine once daily for 12 weeks. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
Secondary outcomes (5)
Change in Skin Elasticity
Assessment of skin elasticity using an objective skin measurement device.
Measured: Baseline and Week 12
Change in Malondialdehyde (MDA)
Evaluation of changes in plasma malondialdehyde concentrations.
Measured: Baseline and Week 12
Change in High-sensitivity C-reactive Protein (hs-CRP)
Evaluation of changes in serum hs-CRP concentrations.
Measured: Baseline and Week 12
Change in Interleukin-6 (IL-6)
Evaluation of changes in serum IL-6 concentrations.
Measured: Baseline and Week 12
Incidence of Adverse Events
Number and severity of treatment-emergent adverse events during the study.
Measured: Throughout the 12-week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion16 Oct 2026 (estimated)
- Study completion8 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EUROPEAN LIFE SCIENCE RESEARCH ASSOCIATION
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750002
- Sponsor's protocol ID
- HCT-54749
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available to protect participant confidentiality and proprietary research information.
Publications
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.
PubMed 38018890Borodina 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.
PubMed 32051057Halliwell 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.
PubMed 26772879Cheah 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.
PubMed 22001064Paul 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.
PubMed 19911007
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effects of NVTIA® Ergothioneine Supplementation on Healthy Aging Biomarkers and Skin Health in Healthy Adults
- ClinicalTrials.gov ID
- NCT07750002
- Acronym / sponsor ID
- HCT-54749
- Conditions
- Healthy Aging, Skin Aging, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- EUROPEAN LIFE SCIENCE RESEARCH ASSOCIATIONUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 16 Oct 2026 (estimated)
- Study completion
- 8 Apr 2027 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVTIA® Ergothioneine | Experimental | Dietary Supplement: NVTIA® ErgothioneineParticipants will receive capsules containing NVTIA® Ergothioneine, providing 30 mg ergothioneine once daily for 12 weeks. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive matching placebo capsules identical in appearance to the investigational product once daily for 12 weeks. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants must meet all of the following criteria:
Key exclusion criteria (11 listed)
- Participants meeting any of the following criteria will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVTIA® ErgothioneineAlso: Ergothioneine, L-ErgothioneineNVTIA® Ergothioneine is a standardized branded ergothioneine ingredient manufactured under controlled quality standards for use as a dietary supplement. | Dietary supplement | NVTIA® Ergothioneine |
| PlaceboMatching placebo capsules identical in appearance, color, size, and packaging to the investigational product. One capsule will be administered orally once daily for 12 weeks. | Other | Placebo |
Primary outcome
Change in Plasma 8-Hydroxy-2'-deoxyguanosine (8-OHdG)
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.
5 secondary outcomes
Change in Skin Elasticity
Time frame: Baseline and Week 12
Change in Malondialdehyde (MDA)
Time frame: Baseline and Week 12
Change in High-sensitivity C-reactive Protein (hs-CRP)
Time frame: Baseline and Week 12
Change in Interleukin-6 (IL-6)
Time frame: Baseline and Week 12
Incidence of Adverse Events
Time frame: Throughout the 12-week study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 38018890Tian 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.
- Background: PubMed 32051057Borodina 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.
- Background: PubMed 26772879Halliwell 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.
- Background: PubMed 22001064Cheah 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.
- Background: PubMed 19911007Paul 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.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available to protect participant confidentiality and proprietary research information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NVTIA® Ergothioneine in people with Healthy Aging and Skin Aging, run by EUROPEAN LIFE SCIENCE RESEARCH ASSOCIATION at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Harris (+880 1712 345678, work.director@dcimch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma 8-Hydroxy-2'-deoxyguanosine (8-OHdG) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07750002, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.