Evaluation of Skin Attributes Following Dietary Supplement Consumption

Access Business Group

Status: Completed

Conditions: Skin Condition

Treatments: Dietary Supplement: High dose Polyphenol; Dietary Supplement: Low dose Polyphenol; Dietary Supplement: Placebo Control

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03487965

CRL119515

Details and patient eligibility

About

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

Full 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.

Enrollment: 103 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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103 participants in 3 patient groups, including a placebo group

Low dose Polyphenol

Experimental group

Description:

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

Treatment:

Dietary Supplement: Low dose Polyphenol

High dose Polyphenol

Experimental group

Description:

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

Treatment:

Dietary Supplement: High dose Polyphenol

Placebo control

Placebo Comparator group

Description:

Inert tablet provided to subjects once per day for 16 weeks

Treatment:

Dietary Supplement: Placebo Control