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RecruitingNCT03994367HPUpdated May 8, 2026

Animal and Plant Proteins and Glucose Metabolism

An interventional study of High animal protein isolate and High animal protein whole food in Metabolic Syndrome, Metabolic Syndrome, Protection Against and Glucose Metabolism Disorders, sponsored by University of Missouri-Columbia. Recruiting at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jul 2019; still recruiting 7 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • High Protein
  • Metabolism
  • Diet
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • No intervention
    Standard protein (control)
  • Experimental
    High animal protein isolate

    Other: High animal protein isolate

  • Experimental
    High animal protein whole food

    Other: High animal protein whole food

  • Experimental
    High plant protein isolate

    Other: High plant protein isolate

  • Experimental
    High plant protein whole food

    Other: High plant protein whole food

Interventions

  • OtherHigh animal protein isolate

    Increased dietary protein content from animal protein isolates

  • OtherHigh animal protein whole food

    Increased dietary protein content from animal protein whole food

  • OtherHigh plant protein isolate

    Increased dietary protein content from plant protein isolates

  • OtherHigh plant protein whole food

    Increased dietary protein content from animal protein whole food

06

What researchers measure

Primary outcomes

  1. 24-hour plasma glucose concentration

    Time frame: up to 12 weeks after the intervention

  2. Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure

    Time frame: up to 12 weeks after the intervention

Secondary outcomes

  1. Postprandial plasma glucose concentration

    Time frame: up to 12 weeks after the intervention

  2. mTOR signaling (phospho-S6 content) in circulating monocytes

    Time frame: up to 12 weeks after the intervention

  3. Endothelial function, assessed as reactive hyperemia index

    Time frame: up to 12 weeks after the intervention

  4. Postprandial plasma insulin concentration

    Time frame: up to 12 weeks after the intervention

  5. Postprandial plasma amino acid concentration

    Time frame: up to 12 weeks after the intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03994367
Lead sponsor
University of Missouri-Columbia
Responsible party
Bettina Mittendorfer (Senior Associate Dean for Research, University of Missouri-Columbia) — Principal investigator
First posted
Jun 21, 2019
Start date
Jul 12, 2019
Primary completion
Feb 25, 2028 (estimated)
Completion
Apr 25, 2028 (estimated)
Last update
May 8, 2026

Study contacts

BETTINA MITTENDORFER
Contact
b.mittendorfer@missouri.edu
618-610-3465
Bettina Mittendorfer
principal investigator · University of Missouri-Columbia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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