Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT04352504
Eligibility Criteria:
Inclusion Criteria:
* Healthy Asian females age 18-50 years' old (inclusive)
* Typically consume low fiber/polyphenol diet (beige diet)
* In good health with a BMI of 22 to 30 kg/ m2 (inclusive)
* Non-smokers
* Fitzpatrick Skin type II-IV
* Willing to maintain their normal skin care pattern for the duration of the study
* Willing to maintain their normal diet for the duration of the study but avoid almonds and pretzels.
* Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
Exclusion Criteria:
* Eating a high fiber/polyphenol diet or taking any medication or dietary supplement which interfere with the absorption of polyphenols.
* Women who are pregnant, lactating or trying to become pregnant.
* Currently taking any skin related prescription medication or supplements for less than 3 months.
* Currently consuming \>14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and/or unwilling to limit intake to less than 3 drinks per week during study participation or history of alcohol dependency.
* Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
* History or current diagnosis of serious medical condition such as Type I or Type II diabetes, major surgery, thyroid disease, heart problems (e.g. angina, bypass surgery, myocardial infarction, etc.), presence of implanted cardiac defibrillator or pacemaker, uncontrolled hypertension/high blood pressure, gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease, inflammatory bowel disease, fatty liver or cancer.
* Known allergy to almonds.
* Participation in another clinical trial within 30 days prior to enrollment.
* Any known clinically significant food allergy or intolerance.
* Currently taking any prescription medication or supplements for less than 3 months.
* Is unable or unwilling to comply with the study protocol.
* Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.
* Received a nasally-delivered steroid, antibiotics within the past 14 days.
* Used topical antibiotic or topical steroid on the face,currently taking any prescription medications that increase the risk of photosensitivity or history of taking such medications in the less than 3 months (e.g. alpha-hydroxy acids in cosmetics, antibiotics (ciprofloxacin, doxycycline, levofloxacin, ofloxacin, tetracycline, trimethoprim), antifungals (flucytosine, griseofulvin, voriconazole), antihistamines (cetirizine, diphenhydramine, loratadine, promethazine, cyproheptadine)
* Subjects with a significant medical history or concurrent condition that the investigator(s) feel is not safe for the study
* Is unable or unwilling to comply with the study protocol.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04352504
Study Brief:
Protocol Section:
NCT04352504