Animal and Plant Proteins and Glucose Metabolism (HP)

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.

Study Overview

• Status: Recruiting
• Conditions: Glucose Metabolism Disorders; Metabolic Syndrome; Metabolic Syndrome, Protection Against
• Intervention / Treatment: Other: High animal protein isolate; Other: High animal protein whole food; Other: High plant protein isolate; Other: High plant protein whole food

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BETTINA MITTENDORFER; Phone Number: 618-610-3465; Email: b.mittendorfer@missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Recruiting
      • University of Missouri School of Medicine
      • Contact: BETTINA MITTENDORFER; Phone Number: 618-610-3465; Email: b.mittendorfer@missouri.edu
      • Contact: Email: b.mittendorfer@missouri.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard protein (control)
Experimental: High animal protein isolate	Other: High animal protein isolate; Increased dietary protein content from animal protein isolates
Experimental: High animal protein whole food	Other: High animal protein whole food; Increased dietary protein content from animal protein whole food
Experimental: High plant protein isolate	Other: High plant protein isolate; Increased dietary protein content from plant protein isolates
Experimental: High plant protein whole food	Other: High plant protein whole food; Increased dietary protein content from animal protein whole food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Bettina Mittendorfer, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2019
• Primary Completion (Estimated): February 25, 2025
• Study Completion (Estimated): April 25, 2025

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Diet; Metabolism; High Protein
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: 2097498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No