Evaluation of Skin Attributes Following Dietary Supplement Consumption

A Randomized, Double Blinded, Placebo Controlled Clinical Study to Evaluate Skin Attributes Following Dietary Supplement Consumption

The study is to assess skin attributes of female subjects following 16 weeks of dietary supplement consumption.

Study Overview

• Status: Completed
• Conditions: Skin Condition
• Intervention / Treatment: Dietary supplement: Low dose Polyphenol; Dietary supplement: High dose Polyphenol; Dietary supplement: Placebo Control

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low dose Polyphenol; 130 mg of Aronia Extract with 120 mg of licorice root combination blend provided to subjects once per day for 16 weeks.	Dietary supplement: Low dose Polyphenol; botanical supplement with 25 mg polyphenol
EXPERIMENTAL: High dose Polyphenol; 200 mg of Aronia extract provided to subjects once per day for 16 weeks	Dietary supplement: High dose Polyphenol; botanical supplement with 13 mg polyphenol
PLACEBO_COMPARATOR: Placebo control; Inert tablet provided to subjects once per day for 16 weeks	Dietary supplement: Placebo Control; inert tablet made to mimic the experimental tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Skin Autofluoresence	Change of accumulation of glycation as measured by validated autofluoresence measuring device (AGE Reader)	Change from baseline to 16 weeks, change from 8 weeks to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin elasticity	Relationship between elasticity and skin glycation; elasticity will be measured by cutometer	Change from baseline to 16 weeks; change from 8 weeks to 16 weeks

Collaborators and Investigators

• Sponsor: Access Business Group
• Collaborators: Clinical Research Laboratories
• Investigators: Principal Investigator: Anita L Cham, MD, Clinical Research Laboraties, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2016
• Primary Completion (ACTUAL): June 28, 2017
• Study Completion (ACTUAL): June 28, 2017

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (ACTUAL): April 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: skin elasticity; dicarbonyl compounds; glycation
• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: CRL119515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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