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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT06025292
Eligibility Criteria:
Inclusion Criteria:
* 1\. Males and females ages 40-65 years.
* 2\. BMI 25 to ≤40 kg/m2 (or body fat % ≥25% in males or ≥36% in females)
* 3\. Capable of providing informed consent.
* 4\. COVID-19 negative and/or asymptomatic.
* 5\. Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 4-day study meal period
* 6\. HbA1c: 5.7-6.4% or fasting glucose 100-125 mg/dL
Exclusion Criteria:
* 1\. Participant who does not/will not eat animal protein sources.
* 2\. Allergy to wheat, soy, or common ingredients in plant-based protein products.
* 3\. Body mass index \<25 kg/m2 or \>40 kg/m2.
* 4\. Hemoglobin \<10g/dL at screening.
* 5\. Platelets \<150,000/uL at screening.
* 6\. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
* 7\. History of gastrointestinal bypass/reduction surgery.
* 8\. Pregnant or lactating individuals.
* 9\. History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)
* 10\. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
* 11\. Currently using prescription blood thinning medications.
* 12\. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).
* 13\. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3 and Visit 7.
* 14\. Unwilling to avoid using protein or amino-acid supplements during participation.
* 15\. Unwilling to fast overnight.
* 16\. Unwilling to avoid alcohol, marijuana and CBD products for the four study days.
* 17\. Participants on glucagon-like-peptide-1 receptor agonist (GLP-1-RA) medications for \<1 month or with less than one treatment dose (injection) every two weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT06025292
Study Brief:
Protocol Section:
NCT06025292