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
About this trial
This is an interventional prevention trial for Skin Condition focused on measuring dicarbonyl compounds, skin elasticity, glycation
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
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
NCT ID
NCT03487965
First Posted
March 29, 2018
Last Updated
April 4, 2018
Sponsor
Access Business Group
Collaborators
Clinical Research Laboratories
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
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Evaluation of Skin Attributes Following Dietary Supplement Consumption
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