Animal and Plant Proteins and Glucose Metabolism

NCT ID: NCT03994367

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-12

Study Completion Date

2028-04-25

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.

Detailed Description

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Conditions

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Metabolic Syndrome Metabolic Syndrome, Protection Against Glucose Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard protein (control)

Group Type NO_INTERVENTION

No interventions assigned to this group

High animal protein isolate

Group Type EXPERIMENTAL

High animal protein isolate

Intervention Type OTHER

Increased dietary protein content from animal protein isolates

High animal protein whole food

Group Type EXPERIMENTAL

High animal protein whole food

Intervention Type OTHER

Increased dietary protein content from animal protein whole food

High plant protein isolate

Group Type EXPERIMENTAL

High plant protein isolate

Intervention Type OTHER

Increased dietary protein content from plant protein isolates

High plant protein whole food

Group Type EXPERIMENTAL

High plant protein whole food

Intervention Type OTHER

Increased dietary protein content from animal protein whole food

Interventions

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High animal protein isolate

Increased dietary protein content from animal protein isolates

Intervention Type OTHER

High animal protein whole food

Increased dietary protein content from animal protein whole food

Intervention Type OTHER

High plant protein isolate

Increased dietary protein content from plant protein isolates

Intervention Type OTHER

High plant protein whole food

Increased dietary protein content from animal protein whole food

Intervention Type OTHER

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Bettina Mittendorfer

Senior Associate Dean for Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bettina Mittendorfer

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri School of Medicine

Columbia, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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BETTINA MITTENDORFER

Role: CONTACT

618-610-3465

Facility Contacts

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BETTINA MITTENDORFER

Role: primary

618-610-3465

Role: backup

Other Identifiers

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2097498

Identifier Type: -

Identifier Source: org_study_id

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