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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT03994367
Eligibility Criteria:
Inclusion Criteria:
* age: ≥21 and ≤70 years;
* BMI: \>24.5 and \<32.5 kg/m2;
* habitual protein intake \<0.9 g/kg/day (assessed on 2 weekdays and 2 weekend days by using the HealthWatch 360 app); and
* weight stable (i.e., ≤3% change) and untrained (≤150 min of structured exercise/week) for at least 2 months before entering the study.
Exclusion Criteria:
* prediabetes or type 2 diabetes;
* evidence of chronic kidney disease by medical history or laboratory tests (glomerular filtration rate \<60 ml/min/1.73 m2 or an albumin to creatinine ratio in urine ≥30 mg/g);
* vegetarians or vegans;
* intolerance or allergies to ingredients in the metabolic meal or intervention diet;
* take dietary supplements (e.g., pre- and probiotics, fiber, fish oil) or medications known to affect our study outcomes;
* received antibiotic or antifungal treatment (which affect the microbiome and therefore microbial metabolite production) 2 months before entering the study;
* consume tobacco products or excessive alcohol (women: \>14 drinks/week; men: \>21 drinks/week);
* evidence of significant organ system dysfunction or diseases (e.g., cirrhosis), and
* unwilling or unable to provide informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT03994367
Study Brief:
Protocol Section:
NCT03994367