Clinical trial NCT03487965: 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
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Keywords: dicarbonyl compounds
skin elasticity
glycation
Lead sponsor: Access Business Group
Sponsor class: INDUSTRY
Collaborators: name: Clinical Research Laboratories
First posted: 2018-04-04
Enrollment: 103
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: individuals are assigned prospectively to two different interventions according to a protocol, to evaluate the effect of the interventions
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change of Skin Autofluoresence
timeFrame: Change from baseline to 16 weeks, change from 8 weeks to 16 weeks
Secondary outcomes:
measure: Skin elasticity
timeFrame: Change from baseline to 16 weeks; change from 8 weeks to 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Research Laboraties, LLC
name: Anita L Cham, MD
role: PRINCIPAL_INVESTIGATOR
References: