Recruiting

High Protein Diet

Sponsor:

University of Missouri-Columbia

Code:

NCT03994367

Conditions

Metabolic Syndrome

Metabolic Syndrome, Protection Against

Glucose Metabolism Disorders

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Accepted

Interventions

High animal protein isolate

High animal protein whole food

High plant protein isolate

High plant protein whole food

Study Details

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

Study ID

NCT03994367

Start date

Jul 12, 2019

Status verified date

Apr, 2026

Completion date

Apr 25, 2028

Anticipated

Primary completion date

Feb 25, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Standard protein (control)

experimental: High animal protein isolate

experimental: High animal protein whole food

experimental: High plant protein isolate

experimental: High plant protein whole food

Interventions

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

Primary outcome measure

  • 24-hour plasma glucose concentration [ Time Frame: up to 12 weeks after the intervention ]
  • Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure [ Time Frame: up to 12 weeks after the intervention ]

Central Contacts and Locations

Central contacts

BETTINA MITTENDORFER

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

Locations

University of Missouri School of Medicine

Recruiting

Columbia, Missouri, United States, 65212

Contacts

BETTINA MITTENDORFER

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

b.mittendorfer@missouri.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

May 8, 2026

Last verified

Apr, 2026

Keywords

  • High Protein
  • Metabolism
  • Diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-05-08.