Animal and Plant Proteins and Glucose Metabolism

Not Applicable

Recruiting

• Conditions: Glucose Metabolism Disorders; Metabolic Syndrome; Metabolic Syndrome, Protection Against
• Interventions: Other: High plant protein isolate; Other: High animal protein isolate; Other: High plant protein whole food; Other: High animal protein whole food

• Registration Number: NCT03994367
• Lead Sponsor: University of Missouri-Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-21
• Study Start: 2019-07-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2028-02-25
• Study Completion: 2028-04-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High plant protein isolate	High plant protein isolate	-
High animal protein isolate	High animal protein isolate	-
High plant protein whole food	High plant protein whole food	-
High animal protein whole food	High animal protein whole food	-

Primary Outcome Measures

Name	Time	Method
24-hour plasma glucose concentration	up to 12 weeks after the intervention
Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure	up to 12 weeks after the intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Missouri School of Medicine; 🇺🇸 Columbia, Missouri, United States