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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT02400450
Eligibility Criteria:
Inclusion Criteria:
Participants must meet the following criteria to be eligible for participation in the study:
1. Male, or non-pregnant, non-lactating females, aged 21 - 75 years;
2. Glycated hemoglobin A1c ≥6.0% and \<7.0%;
3. Body-mass index 18-40;
4. Able to read, write and communicate orally in English;
5. Willing to maintain a stable level of activity during participation in the study;
6. Willing to comply with protocol requirements and procedures;
7. Willing to provide written informed consent.
Exclusion Criteria:
Failure to meet any one of the above eligibility criteria will result in an inability to participate in the study. Participants will also be excluded if they have or require any of the following:
1 Previous diagnosis of diabetes or taking diabetes medications (glucose-lowering medications, insulin);
2\. Previous diagnosis of cardiovascular disease (e.g. heart attack, stroke, peripheral artery disease), or taking lipid-lowering medications, or having a surgical procedure/intervention to treat cardiovascular disease (e.g. bypass surgery, stent). \[Note that individuals with hypertension and/or taking anti-hypertensive medication are eligible to participate.\];
3\. Fasting LDL-cholesterol \>160 mg/dL (\>4.1 mmol/L);
4\. Fasting triglycerides \>400 mg/dL (\>4.5 mmol/L);
5\. Serum alanine aminotransferase (ALT) outside the normal range of 7-56 units/L;
6\. Serum creatinine outside the normal range of 0.7-1.3 mg/dL for males and 0.6-1.1 mg/dL for females;
7\. Conditions which affect normal nutrient absorption (e.g. Celiac disease, inflammatory bowel disease);
8\. Untreated endocrine disorders with the potential to affect glucose and lipid metabolism;
9\. In the previous 3 months and during the study, consumption of supplements or herbals in amounts that lower blood glucose or blood lipids (e.g. chromium, margarine with plant sterols, high fibre supplements such as Metamucil, cinnamon extract, ginseng, bitter melon, gamma-linolenic acid);
10\. Food allergies or intolerances which severely limit the variety of study food products that can be consumed;
11\. Eating philosophies or eating patterns that would limit or not include consumption of the study foods;
12\. Any acute medical condition or surgical intervention within the past 3 months;
13\. Conditions or medications which are likely to increase the risk to the participants or study personnel, or to reduce the ability of the participant to comply with the protocol, or affect the results;
14\. Currently participating in or having participated in a food intervention study within the last month;
15\. Inability to adhere to the study protocol;
16\. Unable to obtain blood sample at the screening and/or baseline visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT02400450
Study Brief:
Protocol Section:
NCT02400450