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Evaluation of Skin Attributes Following Dietary Supplement Consumption

Primary Purpose

Skin Condition

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low dose Polyphenol
High dose Polyphenol
Placebo Control
Sponsored by
Access Business Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Condition focused on measuring dicarbonyl compounds, skin elasticity, glycation

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject is a Caucasian or Asian (either Korean, Japanese, or Chinese) female between the ages of 30 and 65 years;
  • Subject is overweight or moderately obese, with a BMI between 27 and 33;
  • Subject is Caucasian and qualifies based on AGE Reader assessment that is at or greater than average for chronological age; OR is Asian and has an obtainable AGE Reader assessment on the left forearm. Screening AGE reader assessment will be done on the left inner forearm;
  • Subject is willing to have fasting blood draws and urine collections at specified visits. At least nine hours fasting is required. Subject is allowed to drink water;
  • Subject is willing to refrain from excessive sun exposure and/or the use of tanning beds;
  • Subject is willing to use daily the provided facial SPF moisturizer and Purpose® cleansing bar;
  • Subject is taking well established, stable doses of prescription and nonprescription medications not indicated to treat a thyroid condition or diabetes;
  • Subject is in generally good health as determined by the medical history and blood panel results in the opinion of the Principal Investigator;
  • Subject is dependable and able to follow directions as outlined in the protocol;
  • Subject agrees to complete and sign a Photography Release Form, providing consent for the capture of facial digital images for use in relation to this clinical study;
  • Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
  • Subject understands and is willing to sign an Informed Consent in conformance with 21 CFR Part 50: "Protection of Human Subjects."

Exclusion Criteria:

  • Subject is pregnant, planning to become pregnant, or nursing;
  • Subject is known to have, or at risk for, photosensitivity reactions (e.g. very sensitive to ultraviolet light);
  • Subject has scars, tattoos, moles, age spots or rashes on the tested areas that the AGE Reader sensor and Cutometer® probe need to be placed;
  • Subject takes prescription anticoagulants (this does not include a daily 81 mg dose of Aspirin);
  • Subject has a history of any type of cancer and/or is currently undergoing treatment for any type of cancer;
  • Subject has either a systolic blood pressure above 160 or a diastolic blood pressure above 100 at any time during the study;
  • Subject has a thyroid condition;
  • Subject is diabetic or taking any medication or herbal supplement to lower their blood glucose

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Low dose Polyphenol

    High dose Polyphenol

    Placebo control

    Arm Description

    130 mg of Aronia Extract with 120 mg of licorice root combination blend provided to subjects once per day for 16 weeks.

    200 mg of Aronia extract provided to subjects once per day for 16 weeks

    Inert tablet provided to subjects once per day for 16 weeks

    Outcomes

    Primary Outcome Measures

    Change of Skin Autofluoresence
    Change of accumulation of glycation as measured by validated autofluoresence measuring device (AGE Reader)

    Secondary Outcome Measures

    Skin elasticity
    Relationship between elasticity and skin glycation; elasticity will be measured by cutometer

    Full Information

    First Posted
    March 29, 2018
    Last Updated
    April 4, 2018
    Sponsor
    Access Business Group
    Collaborators
    Clinical Research Laboratories
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03487965
    Brief Title
    Evaluation of Skin Attributes Following Dietary Supplement Consumption
    Official Title
    A Randomized, Double Blinded, Placebo Controlled Clinical Study to Evaluate Skin Attributes Following Dietary Supplement Consumption
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 28, 2016 (Actual)
    Primary Completion Date
    June 28, 2017 (Actual)
    Study Completion Date
    June 28, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Access Business Group
    Collaborators
    Clinical Research Laboratories

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study is to assess skin attributes of female subjects following 16 weeks of dietary supplement consumption.
    Detailed Description
    This is a 16 week, randomized, double blind, placebo controlled study. Approximately 105 Caucasian and Asian (Korean, Japanese, or Chinese) female subjects will be enrolled. The following clinical assessments will be performed: (1)VISIA-CR™ digital photography; (2)AGE Reader SU measurements on the left cheek and left inner forearm; (3) Visual Analog Grading (VAS); (4) Corneometer measurements; and (5) Cutometer measurements. Subjects will return to the clinic at approximately 4 weeks, 8 weeks and 16 weeks from the baseline visit for similar measurements. A self-perception questionnaire will be administered at the conclusion of the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Condition
    Keywords
    dicarbonyl compounds, skin elasticity, glycation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    individuals are assigned prospectively to two different interventions according to a protocol, to evaluate the effect of the interventions
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Interventions coded, blinded code kept in sealed envelope until study closed
    Allocation
    Randomized
    Enrollment
    103 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low dose Polyphenol
    Arm Type
    Experimental
    Arm Description
    130 mg of Aronia Extract with 120 mg of licorice root combination blend provided to subjects once per day for 16 weeks.
    Arm Title
    High dose Polyphenol
    Arm Type
    Experimental
    Arm Description
    200 mg of Aronia extract provided to subjects once per day for 16 weeks
    Arm Title
    Placebo control
    Arm Type
    Placebo Comparator
    Arm Description
    Inert tablet provided to subjects once per day for 16 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Low dose Polyphenol
    Intervention Description
    botanical supplement with 25 mg polyphenol
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    High dose Polyphenol
    Intervention Description
    botanical supplement with 13 mg polyphenol
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo Control
    Intervention Description
    inert tablet made to mimic the experimental tablets
    Primary Outcome Measure Information:
    Title
    Change of Skin Autofluoresence
    Description
    Change of accumulation of glycation as measured by validated autofluoresence measuring device (AGE Reader)
    Time Frame
    Change from baseline to 16 weeks, change from 8 weeks to 16 weeks
    Secondary Outcome Measure Information:
    Title
    Skin elasticity
    Description
    Relationship between elasticity and skin glycation; elasticity will be measured by cutometer
    Time Frame
    Change from baseline to 16 weeks; change from 8 weeks to 16 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject is a Caucasian or Asian (either Korean, Japanese, or Chinese) female between the ages of 30 and 65 years; Subject is overweight or moderately obese, with a BMI between 27 and 33; Subject is Caucasian and qualifies based on AGE Reader assessment that is at or greater than average for chronological age; OR is Asian and has an obtainable AGE Reader assessment on the left forearm. Screening AGE reader assessment will be done on the left inner forearm; Subject is willing to have fasting blood draws and urine collections at specified visits. At least nine hours fasting is required. Subject is allowed to drink water; Subject is willing to refrain from excessive sun exposure and/or the use of tanning beds; Subject is willing to use daily the provided facial SPF moisturizer and Purpose® cleansing bar; Subject is taking well established, stable doses of prescription and nonprescription medications not indicated to treat a thyroid condition or diabetes; Subject is in generally good health as determined by the medical history and blood panel results in the opinion of the Principal Investigator; Subject is dependable and able to follow directions as outlined in the protocol; Subject agrees to complete and sign a Photography Release Form, providing consent for the capture of facial digital images for use in relation to this clinical study; Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164; Subject understands and is willing to sign an Informed Consent in conformance with 21 CFR Part 50: "Protection of Human Subjects." Exclusion Criteria: Subject is pregnant, planning to become pregnant, or nursing; Subject is known to have, or at risk for, photosensitivity reactions (e.g. very sensitive to ultraviolet light); Subject has scars, tattoos, moles, age spots or rashes on the tested areas that the AGE Reader sensor and Cutometer® probe need to be placed; Subject takes prescription anticoagulants (this does not include a daily 81 mg dose of Aspirin); Subject has a history of any type of cancer and/or is currently undergoing treatment for any type of cancer; Subject has either a systolic blood pressure above 160 or a diastolic blood pressure above 100 at any time during the study; Subject has a thyroid condition; Subject is diabetic or taking any medication or herbal supplement to lower their blood glucose
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anita L Cham, MD
    Organizational Affiliation
    Clinical Research Laboraties, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluation of Skin Attributes Following Dietary Supplement Consumption

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