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 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT01961869
Eligibility Criteria:
Inclusion Criteria:
* Be healthy, free-living adults
* Be a non-smoker (defined as adults who have never smoked or who have not had a cigarette in the past ten years)
* Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition and alternative supplements for the duration of the study
* Agree to follow a berry-restricted diet and to document any accidental consumption of restricted foods each day of the study
* Agree to abstain from mouthwashes
Exclusion Criteria:
* Have an active metabolic or digestive illness including malabsorptive disorders, renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome
* Have an active or a recent history of any condition that causes altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, and blood dyscrasias
* Have a known allergy or food intolerance to ingredients in study products (black raspberries),other berries, wheat, or soy
* Are strict vegans (no consumption of animal, fish or egg products)
* Are planning to conceive, or are currently pregnant or lactating
* Are heavy alcohol consumers (defined as an average consumption of greater than 2 drinks/day)
* Have a history of oral cancer or currently undergoing treatment of oral cancer
* In the last month have had any active oral lesions or maladies or currently have any oral disease or obvious open sores in the oral cavity or surrounding the oral opening
* Have strong gag reflex or problems swallowing that prohibit buccal brushing of the oral cavity
* Have been on an antibiotic regime lasting for one week in the last 6 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01961869
Study Brief:
Protocol Section:
NCT01961869