NVTIA® Ergothioneine for Healthy Aging and Skin Health

Официальное название

A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effects of NVTIA® Ergothioneine Supplementation on Healthy Aging Biomarkers and Skin Health in Healthy Adults

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка NVTIA® Ergothioneine
  NVTIA® Ergothioneine is a standardized branded ergothioneine ingredient manufactured under controlled quality standards for use as a dietary supplement.
• Другое Placebo
  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.

Первичные конечные точки

• Change in Plasma 8-Hydroxy-2'-deoxyguanosine (8-OHdG) [Срок оценки: Baseline and Week 12]

Вторичные конечные точки (5)

• Change in Skin Elasticity [Срок оценки: Baseline and Week 12]
• Change in Malondialdehyde (MDA) [Срок оценки: Baseline and Week 12]
• Change in High-sensitivity C-reactive Protein (hs-CRP) [Срок оценки: Baseline and Week 12]
• Change in Interleukin-6 (IL-6) [Срок оценки: Baseline and Week 12]
• Incidence of Adverse Events [Срок оценки: Throughout the 12-week study]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Bangladesh · 1 центр

• Dhaka Central International Medical College & Hospital — Dhaka

Публикации

• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07750002 · HCT-54749

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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