Animal and Plant Proteins and Glucose Metabolism

NCT03994367 | Recruiting

• 1 other identifier: 2097498
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Metabolic Syndrome, Protection Against; Glucose Metabolism Disorders

Keywords

High Protein; Metabolism; Diet

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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 Arms (5)

Standard protein (control)

NO INTERVENTION

High animal protein isolate

EXPERIMENTAL

Other: High animal protein isolate

High animal protein whole food

EXPERIMENTAL

Other: High animal protein whole food

High plant protein isolate

EXPERIMENTAL

Other: High plant protein isolate

High plant protein whole food

EXPERIMENTAL

Other: High plant protein whole food

Interventions

High animal protein isolate OTHER

Increased dietary protein content from animal protein isolates

High animal protein isolate

High animal protein whole food OTHER

Increased dietary protein content from animal protein whole food

High animal protein whole food

High plant protein isolate OTHER

Increased dietary protein content from plant protein isolates

High plant protein isolate

High plant protein whole food OTHER

Increased dietary protein content from animal protein whole food

High plant protein whole food

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri School of Medicine

Columbia, Missouri, 65212, United States

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bettina Mittendorfer

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BETTINA MITTENDORFER

CONTACT

618-610-3465; b.mittendorfer@missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Dean for Research

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 21, 2019
• Study Start: July 12, 2019
• Primary Completion (Estimated): February 25, 2028
• Study Completion (Estimated): April 25, 2028
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)