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Clinical Trials/NCT03994367
NCT03994367
Recruiting
Not Applicable

Animal and Plant Proteins and Glucose Metabolism

University of Missouri-Columbia1 site in 1 country100 target enrollmentJuly 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
University of Missouri-Columbia
Enrollment
100
Locations
1
Primary Endpoint
24-hour plasma glucose concentration
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 12, 2019
End Date
April 25, 2028
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bettina Mittendorfer

Senior Associate Dean for Research

University of Missouri-Columbia

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.

Outcomes

Primary Outcomes

24-hour plasma glucose concentration

Time Frame: up to 12 weeks after the intervention

Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure

Time Frame: up to 12 weeks after the intervention

Secondary Outcomes

  • Postprandial plasma glucose concentration(up to 12 weeks after the intervention)
  • mTOR signaling (phospho-S6 content) in circulating monocytes(up to 12 weeks after the intervention)
  • Endothelial function, assessed as reactive hyperemia index(up to 12 weeks after the intervention)
  • Postprandial plasma insulin concentration(up to 12 weeks after the intervention)
  • Postprandial plasma amino acid concentration(up to 12 weeks after the intervention)

Study Sites (1)

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