Clinical trial NCT03994367: Animal and Plant Proteins and Glucose Metabolism
Official title: Animal and Plant Proteins and Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Metabolic Syndrome, Protection Against
Glucose Metabolism Disorders
Keywords: High Protein
Metabolism
Diet
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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.

Primary outcomes:
measure: 24-hour plasma glucose concentration
timeFrame: up to 12 weeks after the intervention
measure: Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure
timeFrame: up to 12 weeks after the intervention
Secondary outcomes:
measure: Postprandial plasma glucose concentration
timeFrame: up to 12 weeks after the intervention
measure: mTOR signaling (phospho-S6 content) in circulating monocytes
timeFrame: up to 12 weeks after the intervention
measure: Endothelial function, assessed as reactive hyperemia index
timeFrame: up to 12 weeks after the intervention
measure: Postprandial plasma insulin concentration
timeFrame: up to 12 weeks after the intervention
measure: Postprandial plasma amino acid concentration
timeFrame: up to 12 weeks after the intervention
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri School of Medicine
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Bettina Mittendorfer
role: PRINCIPAL_INVESTIGATOR
References: