ClinicalTrials.gg
CompletedNCT03487965Updated Apr 6, 2018

Evaluation of Skin Attributes Following Dietary Supplement Consumption

An interventional study of Low dose Polyphenol and High dose Polyphenol in Skin Condition, sponsored by Access Business Group. Completed. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-06.

Sponsored by Access Business Group · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Apr 2016, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Skin Condition

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Keywords

  • dicarbonyl compounds
  • skin elasticity
  • glycation
03

In context

Skin Diseases

496 studies on the registry are indexed under Skin Diseases; 77 are open to participants now.

This study's enrollment of 103 is above the median of 70 across 375 interventional studies indexed under Skin Diseases.

Browse Skin Diseases studies →

Lead sponsor

Access Business Group is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 in conformance with 21 CFR Part 50: "Protection of Human Subjects."

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
103 participants (actual)

Study arms

  • 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

  • Experimental
    High dose Polyphenol

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

    Dietary Supplement: High dose Polyphenol

  • Placebo comparator
    Placebo control

    Inert tablet provided to subjects once per day for 16 weeks

    Dietary Supplement: Placebo Control

Interventions

  • Dietary supplementLow dose Polyphenol

    botanical supplement with 25 mg polyphenol

  • Dietary supplementHigh dose Polyphenol

    botanical supplement with 13 mg polyphenol

  • Dietary supplementPlacebo Control

    inert tablet made to mimic the experimental tablets

06

What researchers measure

Primary outcomes

  1. Change of Skin Autofluoresence

    Change of accumulation of glycation as measured by validated autofluoresence measuring device (AGE Reader)

    Time frame: Change from baseline to 16 weeks, change from 8 weeks to 16 weeks

Secondary outcomes

  1. Skin elasticity

    Relationship between elasticity and skin glycation; elasticity will be measured by cutometer

    Time frame: Change from baseline to 16 weeks; change from 8 weeks to 16 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2016 to primary completion in Jun 2017, 14 months.

Of 53 industry-sponsored interventional studies with no phase under Skin Diseases, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 9. This study's 14 months is above that.

Counting every sponsor, half of 95 studies reached it within 7 months; a quarter within 2 and three quarters within 22.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2018
First posted
Apr 4, 2018
StartActual
Apr 28, 2016
Primary completionActual
Jun 28, 2017
CompletionActual
Jun 28, 2017
Last update
Apr 6, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03487965
Lead sponsor
Access Business Group
Collaborators
Clinical Research Laboratories
Responsible party
Sponsor
First posted
Apr 4, 2018
Start date
Apr 28, 2016
Primary completion
Jun 28, 2017
Completion
Jun 28, 2017
Last update
Apr 6, 2018

Study contacts

Anita L Cham, MD
principal investigator · Clinical Research Laboraties, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Polyphenol

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