Evaluation of Skin Attributes Following Dietary Supplement Consumption

NCT ID: NCT03487965

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-28
• Study Completion Date: 2017-06-28

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.

Conditions

Skin Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Low dose Polyphenol

Intervention Type: DIETARY_SUPPLEMENT

botanical supplement with 25 mg polyphenol

High dose Polyphenol

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

Group Type: EXPERIMENTAL

High dose Polyphenol

Intervention Type: DIETARY_SUPPLEMENT

botanical supplement with 13 mg polyphenol

Placebo control

Inert tablet provided to subjects once per day for 16 weeks

Group Type: PLACEBO_COMPARATOR

Placebo Control

Intervention Type: DIETARY_SUPPLEMENT

inert tablet made to mimic the experimental tablets

Interventions

Low dose Polyphenol

botanical supplement with 25 mg polyphenol

Intervention Type: DIETARY_SUPPLEMENT

High dose Polyphenol

botanical supplement with 13 mg polyphenol

Intervention Type: DIETARY_SUPPLEMENT

Placebo Control

inert tablet made to mimic the experimental tablets

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Clinical Research Laboratories

UNKNOWN

Sponsor Role: collaborator

Access Business Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anita L Cham, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Laboraties, LLC

Other Identifiers

CRL119515

Identifier Type: -

Identifier Source: org_study_id