Animal and Plant Proteins and Glucose Metabolism (HP)

University of Missouri (MU)

Status: Enrolling

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

Treatments: Other: High animal protein whole food; Other: High plant protein whole food; Other: High animal protein isolate; Other: High plant protein isolate

Study type: Interventional

Funder types: Other

Identifiers

NCT03994367

2097498

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 5 patient groups

Standard protein (control)

No Intervention group

High animal protein isolate

Experimental group

Treatment:

Other: High animal protein isolate

High animal protein whole food

Experimental group

Treatment:

Other: High animal protein whole food

High plant protein isolate

Experimental group

Treatment:

Other: High plant protein isolate

High plant protein whole food

Experimental group

Treatment:

Other: High plant protein whole food