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:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT02445560
Eligibility Criteria:
Inclusion Criteria:
To participate in the study you must
* be a woman 65 years of age or older
* be willing to complete daily and weekly questionnaires
* be willing to wear a SenseWear Pro Armband (BodyMedia, Inc.) to monitor energy expenditure and establish dietary energy needs
* be willing to provide blood samples, stool samples, and urine samples throughout the course of the study
* be willing to discontinue prebiotics, probiotics and/or any fiber supplements for the duration of the study
* be willing to consume the provided diet for the designated 8 weeks of the study
* are willing to report and maintain their usual alcohol intake throughout the study
* are able to take foods, study fiber, probiotic, and placebo without the aid of another person
* able to attend all scheduled study appointments for the duration of the study
* have a usual protein intake consistent with United States' population as assessed by dietary analysis
* have a usual fiber intake consistent with United States' population as assessed by dietary analysis
* be willing to provide a social security number to receive study payment.
Exclusion Criteria:
To participate in the study you must NOT
* have a physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, peptic ulcer disease, cancer, celiac disease, short bowel disease, ileostomy)
* have had or are currently being treated for any known illnesses or conditions that may impact perceived health such as HIV/AIDS, immune modulating diseases (autoimmune, hepatitis, cancer, etc.), diabetes or chronic kidney disease
* be a vegetarian
* have any known food allergies or dietary restrictions
* be currently taking medication for constipation or diarrhea
* have taken antibiotics within the past 2 months
* be a current smoker
* be planning on loosing/gaining weight during the next 6 months
* typically consume no more than one alcoholic beverage per day
* have a BMI greater than 30
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
65 Years
Study:
NCT02445560
Study Brief:
Protocol Section:
NCT02445560