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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03994367
Other study ID # 2097498
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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