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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT07235358
Eligibility Criteria:
Inclusion Criteria:
* Age 25-65 years
* Prediabetes assessed by an HbA1c of 5.7-6.4% at screening
* BMI 25-40 kg/m2 at screening
* Low habitual nut consumption (\<3.5 oz-eq/week) assessed at the telephone screening
* Regularly eats snacks higher in saturated fat and/or added sugars assessed at the telephone screening
Exclusion Criteria:
* LDL-C ≥190 mg/dL at screening
* Hemoglobin \<13.2 g/dL at screening
* Fasting triglycerides \>350 mg/dL at screening
* ≥10% change in body weight within the 6 months prior to enrollment
* Blood pressure \>140/90 mmHg at screening
* Type 1 or type 2 diabetes
* Prescription of anti-hypertensive, lipid-lowering, or glucose-lowering drugs
* Intake of supplements or over-the-counter medications that affect the outcomes of interest (i.e., lipid, blood pressure, or glucose lowering; vitamin C or multi-vitamins containing vitamin C) and are unwilling to cease during the study period.
* History of liver, kidney, or autoimmune disease
* Prior cardiovascular event (e.g., stroke, heart attack)
* Current pregnancy or intention of pregnancy within the next 12 months
* Lactation within the prior 6 months
* Pecan allergy/intolerance/sensitivity/dislike
* Unwilling/unable to eat 1.5 oz of pecans every day as a snack during the duration of the study
* Antibiotic use within the prior 4 weeks
* Oral steroid use within the prior 4 weeks
* Use of tobacco or nicotine-containing products within the past 6 months
* History of cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer within the past 5 years (eligible if ≥5 years without recurrence)
* Participation in another clinical trial within 60 days of baseline
* Unwilling to contact study staff before enrolling in other health-related research and avoid participating in any research that may interfere with this study.
* Currently following a restricted or weight-loss diet
* Prior bariatric surgery
* Intake of \>14 alcoholic drinks/week and/or not willing to avoid alcohol consumption for 48 hours prior to test visits
* Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements, including being able to come to attend visits
* Does not speak and/or understand English
* Unwilling to refrain from donating blood or plasma during the study
* Weight \<110 lb
* If a potential participant takes thyroid medicine, abnormal thyroid stimulated hormone (TSH) concentration (TSH outside of normal range), or change in dose of thyroid medication within the last 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT07235358
Study Brief:
Protocol Section:
NCT07235358