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NCT Number: NCT03994367

Animal and Plant Proteins and Glucose Metabolism

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.

Recruiting

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High animal protein isolate

Other

Increased dietary protein content from animal protein isolates

High animal protein whole food

Other

Increased dietary protein content from animal protein whole food

High plant protein isolate

Other

Increased dietary protein content from plant protein isolates

High plant protein whole food

Other

Increased dietary protein content from animal protein whole food

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

Study contacts

Contact information is provided by the study sponsor or research team.

BETTINA MITTENDORFER

CONTACT

[email protected]

618-610-3465

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Acronym: HP

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Jun 21, 2019
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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