Animal and Plant Proteins and Glucose Metabolism

Metabolic Syndrome Clinical Trial

— HP  

Official title:

Animal and Plant Proteins and Glucose Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03994367
• Other study ID #: 2097498
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2019
• Est. completion date: April 25, 2025

Study information

• Verified date: March 2024
• Source: University of Missouri-Columbia
• Contact: BETTINA MITTENDORFER
• Phone: 618-610-3465
• Email: b.mittendorfer[@]missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 25, 2025
• Est. primary completion date: February 25, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases
• Metabolic Syndrome
• Metabolic Syndrome, Protection Against
• Syndrome

Intervention

Other:
• High animal protein isolate
Increased dietary protein content from animal protein isolates
• High animal protein whole food
Increased dietary protein content from animal protein whole food
• High plant protein isolate
Increased dietary protein content from plant protein isolates
• High plant protein whole food
Increased dietary protein content from animal protein whole food

Locations

Country	Name	City	State
United States	University of Missouri School of Medicine	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour plasma glucose concentration		up to 12 weeks after the intervention
Primary	Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure		up to 12 weeks after the intervention
Secondary	Postprandial plasma glucose concentration		up to 12 weeks after the intervention
Secondary	mTOR signaling (phospho-S6 content) in circulating monocytes		up to 12 weeks after the intervention
Secondary	Endothelial function, assessed as reactive hyperemia index		up to 12 weeks after the intervention
Secondary	Postprandial plasma insulin concentration		up to 12 weeks after the intervention
Secondary	Postprandial plasma amino acid concentration		up to 12 weeks after the intervention