Animal and Plant Proteins and Glucose Metabolism

Study Overview
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Brief Summary
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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.

Official Title
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Animal and Plant Proteins and Glucose Metabolism

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

Intervention / Treatment
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* Other: High animal protein isolate
* Other: High animal protein whole food
* Other: High plant protein isolate
* Other: High plant protein whole food


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard protein (control)<br> | |
| Experimental: High animal protein isolate<br> | Other: High animal protein isolate<br>* Increased dietary protein content from animal protein isolates<br>|
| Experimental: High animal protein whole food<br> | Other: High animal protein whole food<br>* Increased dietary protein content from animal protein whole food<br>|
| Experimental: High plant protein isolate<br> | Other: High plant protein isolate<br>* Increased dietary protein content from plant protein isolates<br>|
| Experimental: High plant protein whole food<br> | Other: High plant protein whole food<br>* Increased dietary protein content from animal protein whole food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour plasma glucose concentration |  | up to 12 weeks after the intervention | 
| Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure |  | up to 12 weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial plasma glucose concentration |  | up to 12 weeks after the intervention | 
| mTOR signaling (phospho-S6 content) in circulating monocytes |  | up to 12 weeks after the intervention | 
| Endothelial function, assessed as reactive hyperemia index |  | up to 12 weeks after the intervention | 
| Postprandial plasma insulin concentration |  | up to 12 weeks after the intervention | 
| Postprandial plasma amino acid concentration |  | up to 12 weeks after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Protein, Metabolism, Diet