NCT03994367 Animal and Plant Proteins and Glucose Metabolism
| NCT ID | NCT03994367 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Missouri-Columbia |
| Condition | Metabolic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2019-07-12 |
| Primary Completion | 2028-02-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2019-07-12 with a primary completion date of 2028-02-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this proposal is to determine the effect of a high protein diet in which the increase in protein intake is derived from different sources (animal vs plant and protein-rich whole foods vs protein isolates) on: i) liver and muscle insulin sensitivity; ii) the metabolic response to a meal, and iii) 24-h plasma concentration profiles of glucose, glucoregulatory hormones, and protein-derived metabolites purported to cause metabolic dysfunction.
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.
Contact & Investigator
Bettina Mittendorfer
PRINCIPAL INVESTIGATOR
University of Missouri-Columbia
Frequently Asked Questions
Who can join the NCT03994367 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 70 Years, studying Metabolic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03994367 currently recruiting?
Yes, NCT03994367 is actively recruiting participants. Contact the research team at b.mittendorfer@missouri.edu for enrollment information.
Where is the NCT03994367 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT03994367 clinical trial?
NCT03994367 is sponsored by University of Missouri-Columbia. The principal investigator is Bettina Mittendorfer at University of Missouri-Columbia. The trial plans to enroll 100 participants.