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 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT01973595
Eligibility Criteria:
Inclusion Criteria:
To participate in the study, adult participants must:
* Be 18 to 40 years old.
* Have a 3 to 6 year old child that you are willing to enroll in the study.
* Live with your child for on average at least 6 days of the week.
* Be willing and able to complete the Informed Consent Form in English.
* Not be currently pregnant or planning to become pregnant in the next 5 months.
* Be willing to consume 1.5 ounces of almonds (\~43 nuts) each day for three weeks.
* Be willing to feed your child 0.5 ounces of almond paste (\~2 tablespoons) per day for three weeks.
* Be willing monitor your child's daily intake over the course of the study.
* Be willing to provide 4 blood samples, 4 stool samples, and 4 saliva samples over the course of the study.
* Be willing to assist your child in providing 4 stool samples and 4 saliva samples over the course of the study.
* Be willing and able to complete daily and weekly questionnaires for you and your child regarding general wellness, bowel function, gastrointestinal symptoms, stress and anxiety, and dietary intake.
* Must be available for 14 consecutive weeks to participate in the study.
Exclusion Criteria:
To participate in the study, adult and child participants:
* Must not have any known nut or tree nut allergies.
* Must discontinue any immune-enhancing dietary supplements (e.g., prebiotics and fiber supplements, probiotics, fish oil, vitamin E \>400% of the Recommended Dietary Allowance (RDA) or \>60 mg/day, and yogurts with live, active cultures).
* Must not be currently taking any medications for constipation or diarrhea on a regular basis.
* Must not be currently taking any large doses of anti-inflammatory drugs (i.e., aspirin in doses \>600 mg/d) on a regular basis.
* Must not have received antibiotic therapy or a colonoscopy in the past two months.
* Must not be currently being treated for or have any of the following physician-diagnosed diseases or conditions: HIV/AIDS; immune modulating diseases (autoimmune disease, hepatitis, cancer); kidney disease; pancreatitis; pulmonary disease; hepatic or biliary disease; or gastrointestinal diseases/conditions such as diverticulitis, ulcerative colitis, Crohn's disease, Celiac disease, short bowel disease, ileostomy, or colostomy, but not including gastroesophageal reflux disease; or have a central venous catheter.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01973595
Study Brief:
Protocol Section:
NCT01973595