What this study is
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.
What's being tested
- High animal protein isolate
Intervention · OTHER
Increased dietary protein content from animal protein isolates
- High animal protein whole food
Intervention · OTHER
- High plant protein isolate
Intervention · OTHER
Increased dietary protein content from plant protein isolates
- High plant protein whole food
Intervention · OTHER
Both High animal protein whole food and High plant protein whole food
Increased dietary protein content from animal protein whole food
Study details
- Sponsor
- University of Missouri-Columbia
- Conditions
- Metabolic Syndrome · Metabolic Syndrome, Protection Against · Glucose Metabolism Disorders
- Enrolling
- 100 people
- Starts
- 2019-07-12
- Est. completion
- 2028-04-25
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years – 70 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Missouri School of Medicine
Columbia, Missouri, United States
- BETTINA MITTENDORFER · Contact618-610-3465b.mittendorfer@missouri.edu
- Contactb.mittendorfer@missouri.edu
Recruiting
Study team
Sponsor
University of Missouri-Columbia
Study ID 2097498
Principal investigator
Bettina Mittendorfer
University of Missouri-Columbia
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.