Effect of Continuous Intake of Ergothioneine-containing Supplements on Skin Condition

NCT ID: NCT06886061

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-09
• Study Completion Date: 2025-03-03

Brief Summary

This trial employed a non-randomized, double-blind, placebo-controlled design to evaluate the effects of DR. ERGO® Capsules (each containing 30mg of ergothioneine) on the skin condition of women aged 35 to 59 after continuous daily intake for 8 weeks. The trial assessed skin condition across multiple dimensions, including brightness, color tone, melanin, erythema, gloss, elasticity, and spots, using various instruments and questionnaire surveys. Additionally, safety was monitored through daily log records and safety evaluations.

Detailed Description

Ergothioneine (EGT), a naturally occurring amino acid-like antioxidant, was first discovered in Clavieps purpurea in 1909. It is widely found in mushrooms, legumes, and certain animal tissues. Studies have shown that ergothioneine protects skin cells by scavenging free radicals and reducing oxidative stress, thereby delaying skin aging. Additionally, it can inhibit melanin production, improve uneven skin tone, enhance the skin barrier function, and boost skin elasticity and radiance. In recent years, with growing attention to nutricosmetics, ergothioneine has gained significant interest for its potential anti-aging and skin-enhancing benefits.

The trial employed a non-randomized, double-blind, placebo-controlled design, adhering to the principles of the Helsinki Declaration and relevant Japanese ethical guidelines, and received approval from an ethics review committee. The primary objective of the study was to evaluate the effects of daily consumption of one DR. ERGO® capsule (each containing 30mg of ergothioneine) on the skin condition of women aged 35 to 59 over an 8-week period.

The trial design included strict inclusion and exclusion criteria to ensure consistency in the health status and testing conditions of the participants. During the trial, participants were required to maintain their normal lifestyle habits and avoid using any medications or cosmetics that might affect their skin condition. The study assessed skin condition across multiple dimensions-including brightness, color tone, melanin levels, erythema, gloss, elasticity, spots, and wrinkles-using various instruments and questionnaires. Additionally, safety was monitored through diary logs and safety assessments.

Conditions

Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Group

The placebo group continuously ingests capsules without Ergothioneine over a period of 8 weeks.

Group Type: PLACEBO_COMPARATOR

The capsules do not contain Ergothioneine.

Intervention Type: DIETARY_SUPPLEMENT

Take one capsule devoid of Ergothioneine orally every day for a period of eight weeks.

Ergothioneine Group

The Ergothioneine group continuously ingests one capsule containing 30mg of Ergothioneine per day over a period of 8 weeks.

Group Type: EXPERIMENTAL

The capsules contain Ergothioneine.

Intervention Type: DIETARY_SUPPLEMENT

Take one 30 mg Ergothioneine capsule orally every day for a period of eight weeks.

Interventions

The capsules contain Ergothioneine.

Take one 30 mg Ergothioneine capsule orally every day for a period of eight weeks.

Intervention Type: DIETARY_SUPPLEMENT

The capsules do not contain Ergothioneine.

Take one capsule devoid of Ergothioneine orally every day for a period of eight weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

① Healthy women aged 35 to 59 years old.

② Individuals who feel that their skin condition is deteriorating (loss of radiance, dullness, pigmentation spots, etc.).

Exclusion Criteria

• Individuals with a history of food allergies.

• Pregnant or breastfeeding individuals.

• Individuals with inflammation or wounds on their face.

• Individuals taking medication that could affect the trial. ⑤ Individuals consuming health supplements that could affect the trial.

⑥ Individuals currently undergoing medical treatment or receiving prescriptions from a doctor.

⑦ Individuals undergoing hormone therapy.

⑧ Individuals with eyelash extensions, permanent eyeliner, or other forms of cosmetic tattooing around the eyes.

⑨ Individuals who have participated in human clinical trials within the last month or plan to do so during the trial period.

⑩ Individuals deemed unsuitable by the principal investigator of the trial.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai EGT Synbio Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kaneko Takeshi

Role: PRINCIPAL_INVESTIGATOR

Japan Clinical Trial Association

Locations

Japan Clinical Trial Association N.A.

Tokyo, Shinjukuku, Japan

Countries

Japan

Other Identifiers

UMIN000055792

Identifier Type: -

Identifier Source: org_study_id