A Randomized, Double Blinded, Placebo Controlled Clinical Study to Evaluate Skin Attributes Following Dietary Supplement Consumption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 主要终点
- Change of Skin Autofluoresence
研究概览
简要总结
The study is to assess skin attributes of female subjects following 16 weeks of dietary supplement consumption.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Interventions coded, blinded code kept in sealed envelope until study closed
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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."
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Low dose Polyphenol (Dietary Supplement)
High dose Polyphenol
200 mg of Aronia extract provided to subjects once per day for 16 weeks
干预措施: High dose Polyphenol (Dietary Supplement)
Placebo control
Inert tablet provided to subjects once per day for 16 weeks
干预措施: Placebo Control (Dietary Supplement)
结局指标
主要结局
Change of Skin Autofluoresence
时间窗: Change from baseline to 16 weeks, change from 8 weeks to 16 weeks
Change of accumulation of glycation as measured by validated autofluoresence measuring device (AGE Reader)
次要结局
- Skin elasticity(Change from baseline to 16 weeks; change from 8 weeks to 16 weeks)