Evaluation of Skin Attributes Following Dietary Supplement Consumption

NCT03487965 | Completed

• 1 other identifier: CRL119515
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Skin Condition

Keywords

dicarbonyl compounds; skin elasticity; glycation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Skin elasticity

  Change from baseline to 16 weeks; change from 8 weeks to 16 weeks

Study Arms (3)

Low dose Polyphenol

EXPERIMENTAL

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

High dose Polyphenol

EXPERIMENTAL

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

Dietary Supplement: High dose Polyphenol

Placebo control

PLACEBO COMPARATOR

Inert tablet provided to subjects once per day for 16 weeks

Dietary Supplement: Placebo Control

Interventions

Low dose Polyphenol DIETARY_SUPPLEMENT

botanical supplement with 25 mg polyphenol

Low dose Polyphenol

High dose Polyphenol DIETARY_SUPPLEMENT

botanical supplement with 13 mg polyphenol

High dose Polyphenol

Placebo Control DIETARY_SUPPLEMENT

inert tablet made to mimic the experimental tablets

Placebo control

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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."

You may not qualify if:

• 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

Sponsors & Collaborators

• Access Business Group: lead
• Clinical Research Laboratories: collaborator

MeSH Terms

Conditions

Skin Diseases

Interventions

Polyphenols

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Anita L Cham, MD

  Clinical Research Laboraties, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Interventions coded, blinded code kept in sealed envelope until study closed
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: individuals are assigned prospectively to two different interventions according to a protocol, to evaluate the effect of the interventions

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 4, 2018
• Study Start: April 28, 2016
• Primary Completion: June 28, 2017
• Study Completion: June 28, 2017
• Last Updated: April 6, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share