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Recruiting NCT03994367

Animal and Plant Proteins and Glucose Metabolism

No phase Interventional Metabolic Syndrome Metabolic Syndrome, Protection Against Glucose Metabolism Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High animal protein isolate, High animal protein whole food, High plant protein isolate, High plant protein whole food.
Who it may be relevant to
Registry conditions: Metabolic Syndrome, Metabolic Syndrome, Protection Against, Glucose Metabolism Disorders. Basic parameters: 21 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Postprandial plasma glucose concentration [Time frame: up to 12 weeks after the intervention]
  • mTOR signaling (phospho-S6 content) in circulating monocytes [Time frame: up to 12 weeks after the intervention]
  • Endothelial function, assessed as reactive hyperemia index [Time frame: up to 12 weeks after the intervention]
  • Postprandial plasma insulin concentration [Time frame: up to 12 weeks after the intervention]
  • Postprandial plasma amino acid concentration [Time frame: up to 12 weeks after the intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Missouri School of Medicine — Columbia

Identifiers

NCT: NCT03994367 · 2097498

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗