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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT01903304
Eligibility Criteria:
Inclusion Criteria:
1. Must be willing to be randomized into study groups.
2. Men and women ≥ 65 years of age.
3. Body mass index (BMI) between 25 - 35 kg/m2.
4. Consumption of typical American diet.
5. Must be willing to stop taking multivitamins, and supplements (with the exception of vitamin D and calcium), including fish oil or n-3 fatty acids and herbal supplements, for 30 days prior to and during study participation, if currently taking these.
Exclusion Criteria:
1. Using olive oil or canola oil as the predominant oil for cooking for the past 6 months, but eligible if willing to stop taking these oils for 30 days prior to participation.
2. Currently on a vegetarian diet.
3. Eats more than 3 meals per week at a restaurant.
4. Consumes fish more than three times per week; but eligible if willing to stop fish consumption 30 days prior to participation and during participation..
5. Disordered eating habits:
* "Crash" diets
* Bingeing or food sprees
* Failure to consume a consistent diet, or demonstrates regular changes in patterns of dietary intake.
6. Heavy consumption of alcohol (more than 2 glasses of alcoholic drinks per day).
7. HIV+ by self-report.
8. Autoimmune disease, Type 1 diabetes, celiac disease, inflammatory bowel disease (IBD), multiple sclerosis, rheumatoid arthritis, autoimmune hepatitis.
9. Diseases that impact the immune response such as cancer, except for non-melanoma skin cancer, and other neo-plastic diseases.
10. Chemotherapy, anti-neo plastic or immunosuppressive drugs.
11. Any major illnesses that are uncontrolled (not stable on medication) - uncontrolled liver disease, uncontrolled heart or cardiovascular disease, uncontrolled Hypertension, uncontrolled renal disease, uncontrolled asthma.
12. History of smoking or use of nicotine containing products in the past 6 months.
13. Active infection within 4 weeks of study enrollment, blood draws or skin tests; however, may participate if admission is postponed or rescheduled \> 4 weeks after resolution of symptoms.
14. FLU vaccination within 2 weeks prior to study blood draws and skin tests.
15. Currently on antibiotics; if on antibiotics need to be off antibiotics for at least 2 weeks before study enrollment, and 2 weeks prior to blood draws up to 48 hrs after DTH implant (i.e. after second reading). .
16. Chronic prophylactic antibiotic treatment or long term antibiotics.
17. Diagnosis of infections at base¬line will not exclude a subject, but will postpone en¬rollment to 4 wks after symptoms have cleared.
18. Participation in weight reduction program within 6 months prior to study enrollment; but include if enrolled in weight loss program to maintain body weight.
19. History of splenectomy
20. On dialysis
21. Conditions or medications associated with maldigestion or malabsorption, including but not limited to (in the opinion of the study physician), inflammatory bowel disease, chronic pancreatitis, celiac disease, resection of the small intestine, gastric bypass or other surgery for weight loss, and use of orlistat.
22. Known poor compliance to dietary intervention (based on dietary screening interview).
23. Unwillingness to maintain current body weight and level of physical activity during the study period.
24. Consumption of herbal supplements. Interested eligible participants on herbal supplements will be asked to stop taking these while on the study after a 30 day washout period.
25. Use of aspirin, non-steroidal anti-inflammatory medications (NSAIDs) or antihistamine prescribed by a physician or clinician, or the inability to discontinue the use of these substances for 72 hrs before first day blood draw until 48 hrs after DTH implant (i.e. after second reading).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
85 Years
Study:
NCT01903304
Study Brief:
Protocol Section:
NCT01903304