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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT04466761
Eligibility Criteria:
Inclusion Criteria:
* Patients must be 18-45 years of age
* Patients who are in general good health
* Body Mass Index (BMI) range of 18.5-25
* All individuals must have the ability to provide inform consent
Exclusion Criteria:
* Women who are pregnant, actively nursing, or pregnant within the last year
* Women who are peri-menopausal or post-menopausal
* Women with irregular menstrual cycles (more frequently than every 21 days or lasts longer than 8 days (missed, early, or late periods are also considered signs of an irregular cycle).
* Women on hormonal contraception, including birth control, hormonal intrauterine device, or contraceptive implant
* Past medical history of an autoimmune condition or malignancy, excluding non-melanoma skin cancer
* Individuals with first degree relative with history of an autoimmune condition
* Individuals with cardiovascular, pulmonary, reproductive, endocrine, metabolic, neurologic, gastrointestinal, hematologic, or infectious diseases of any kind
* Individuals with diagnosis of galactosemia or congenital disorders of glycosylation
* Individuals with phenylketonuria
* Individuals currently taking prescription medications, or have taken prescription medications within the last 3 months
* Individuals currently taking over the counter medications
* Individuals currently taking or have taken supplements including herbal, protein or vitamin supplements in the last 3 months (e.g. whey protein, St. John's Wort, green tea supplements, biotin, creatine supplements), excluding multivitamins or essential vitamins
* Individuals with prior history of severe food or drug allergic reactions
* Individuals with a diagnosis of type I or II diabetes mellitus
* Individuals with allergic reaction or adverse reaction to shellfish, N-acetyl glucosamine, galactose, or Spirulina/chlorella/algae supplements
* Individuals with social history of current use of tobacco, alcohol or other drugs
* Individuals with dietary restrictions (vegetarians are permitted to participate in the study) or to whom any of the following dietary habits or characteristics apply (the following exclusion criteria are placed to minimize variability in diet in our study population):
* Actively dieting or trying to lose weight
* Vegan diet
* Consume equal to or greater than 2 cups of tea a day
* Consume equal to or greater than 4 cups of coffee a day
* Consume equal to or greater than 3 cups of fruit juice a day
* Practice intensive exercise patterns (marathon training, workouts \>4 hours a day)
* Consume soda or energy drinks of any amount
* On a carbohydrate-restricted or "Paleo" diet
* Calorie-restricted diet (less than 20%-25% of maintenance calories)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04466761
Study Brief:
Protocol Section:
NCT04466761