Evaluation of Human Efficacy of SOD Like Super Drink

December 3, 2024 updated by: TCI Co., Ltd.
To assess the efficacy of SOD like Super Drink on anti-oxidant capacity, immuno regulation and skin for human

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Taichung City, Taiwan, 406040
        • China Medical University of Department of Cosmeceutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy adults aged between 30-65 years old

Exclusion Criteria:

  • Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder
  • Patients with diseases of the skin, liver, kidney.
  • Female who is pregnant or nursing or planning to become pregnant during the course of the study.
  • Received facial laser therapy, chemical peeling or UV overexposure (> 3 hr/week) in the past 4 weeks.
  • Students who are currently taking courses taught by the principal investigator of this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: placebo drink
Dietary supplement: placebo drink
consume 1 bottle per day
Experimental: SOD like Super Drink
Dietary supplement: SOD like Super Drink
consume 1 bottle per day
Other Names:
  • AVON SOD like Super Drink

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the volume of skin wrinkles
Time Frame: Volume change from Baseline skin wrinkles at 8 weeks
IRV full-face skin analyzer was utilized to measure skin wrinkles. Units: arbitrary units
Volume change from Baseline skin wrinkles at 8 weeks
the roughness of skin texture
Time Frame: Rating skin roughness from Baseline skin texture at 8 weeks
IRV full-face skin analyzer was utilized to measure skin texture. Units: arbitrary units
Rating skin roughness from Baseline skin texture at 8 weeks
the change of skin elasticity
Time Frame: Change from Baseline skin elasticity at 8 weeks
Cutometer® was utilized to measure skin elasticity. Units: arbitrary units
Change from Baseline skin elasticity at 8 weeks
the change of Total Anti-oxidative Capacity (TAC) of blood
Time Frame: Change from Baseline TAC at 8 weeks
venous blood was sampled to measure TAC
Change from Baseline TAC at 8 weeks
the change of Superoxide Dismutase (SOD) of blood
Time Frame: Change from Baseline SOD at 8 weeks
venous blood was sampled to measure SOD
Change from Baseline SOD at 8 weeks
the change of Glutathione S-transferase (GST) of blood
Time Frame: Change from Baseline GST at 8 weeks
venous blood was sampled to measure GST
Change from Baseline GST at 8 weeks
the change of Glutathione (GSH) of blood
Time Frame: Change from Baseline GSH at 8 weeks
venous blood was sampled to measure GSH
Change from Baseline GSH at 8 weeks
the change of Malondialdehyde (MDA) of blood
Time Frame: Change from Baseline MDA at 8 weeks
venous blood was sampled to measure MDA
Change from Baseline MDA at 8 weeks
the change of immune-related cytokines of blood
Time Frame: Change from Baseline immune-related cytokines at 8 weeks
venous blood was sampled to measure immune-related cytokines
Change from Baseline immune-related cytokines at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the change of skin surface hydration
Time Frame: Change from Baseline skin surface hydration at 8 week
Corneometer® CM 825 was utilized to measure skin surface hydration. Units: arbitrary units
Change from Baseline skin surface hydration at 8 week
the change of skin Transepidermal Water Loss (TEWL)
Time Frame: Change from Baseline TEWL at 8 week
Tewameter® TM 300 was utilized to measure TEWL. Units: arbitrary units
Change from Baseline TEWL at 8 week
the change of Skin Melanin Index
Time Frame: Change from Baseline skin Melanin Index at 8 week
Mexameter® MX 18was utilized to measure Melanin Index. Units: arbitrary units
Change from Baseline skin Melanin Index at 8 week
the change of Skin Erythema Index
Time Frame: Change from Baseline skin Erythema Index at 8 week
Mexameter® MX 18was utilized to measure skin Erythema Index. Units: arbitrary units
Change from Baseline skin Erythema Index at 8 week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change of liver function biomarkers (AST, ALT) of blood
Time Frame: Change from Baseline liver function biomarkers at 8 weeks
Venous blood was sampled to measure liver function biomarkers
Change from Baseline liver function biomarkers at 8 weeks
The change of renal function biomarkers (creatinine, BUN) of blood
Time Frame: Change from Baseline renal function biomarkers at 8 weeks
Venous blood was sampled to measure renal function biomarkers
Change from Baseline renal function biomarkers at 8 weeks
The change of self-assessment skin condition and immuno condition
Time Frame: Change from Baseline skin condition and immunol condition at 8 weeks
A self-assessment questionnaire was collected to evaluate skin condition and immunol condition，As for the evalutation of skin condition ,the higher score the better；As for evaluation of immunol condition , the higher score the worse
Change from Baseline skin condition and immunol condition at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TCI Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hsiu-Mei Chiang, China Medical University of Department of Cosmeceutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMUH112-REC3-175

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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