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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT03675360
Eligibility Criteria:
Inclusion Criteria:
* Men or women ages 40 to 70 years
* HbA1c 6.0-6.9%
* Willing and able to provide informed consent
Exclusion Criteria:
* Diagnosed type 1 diabetes mellitus
* Use of agents affecting glycemic control (medications for diabetes, oral glucocorticoids) within the past three months prior to enrollment
* Medical condition in which low-carbohydrate diet may not be advised: estimated glomerular filtration rate (eGFR) ≤45 mL/min/1.73 m²; self-report of liver disease due to hepatitis or alcohol; osteoporosis; untreated thyroid disease; gout; cancer (other than non-melanoma skin cancer) requiring treatment in the past year, unless prognosis is excellent
* Factors that may affect HbA1c: hemoglobin \<11 mg/dL (cutpoint for moderate-to-severe anemia, which could lead to falsely elevated or lowered HbA1c); recent blood donation or blood transfusion (self-report, past 4 months); human immunodeficiency virus (self-report)
* Self-reported history of intensive care unit stay due to Coronavirus Disease 2019 (COVID-19) in the past three months, as severe COVID-19 may affect blood glucose levels
* Allergies to nuts
* For women, current pregnancy, breastfeeding, or plans to become pregnant during the study
* Consumption of ≥21 alcoholic drinks per week or consumption of ≥6 drinks per occasion
* Current or planned residence making it difficult to meet trial requirements (due to distance from study site and/or challenges regularly traveling to site)
* Current participation in another lifestyle intervention trial or a pharmaceutical trial
* Participation of another household member in the study; employees or persons living with employees of the study
* Other concerns regarding ability to meet trial requirements, at the discretion of the principal investigator or study coordinator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT03675360
Study Brief:
Protocol Section:
NCT03675360