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Animal and Plant Proteins and Glucose Metabolism

Animal and Plant Proteins and Glucose Metabolism

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03994367
Acronym
HP
Enrollment
100
Registered
2019-06-21
Start date
2019-07-12
Completion date
2028-04-25
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

High Protein, Metabolism, Diet

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.

Interventions

OTHERHigh animal protein isolate

Increased dietary protein content from animal protein isolates

OTHERHigh animal protein whole food

Increased dietary protein content from animal protein whole food

OTHERHigh plant protein isolate

Increased dietary protein content from plant protein isolates

OTHERHigh plant protein whole food

Increased dietary protein content from animal protein whole food

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
24-hour plasma glucose concentrationup to 12 weeks after the intervention
Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedureup to 12 weeks after the intervention

Secondary

MeasureTime frame
Postprandial plasma amino acid concentrationup to 12 weeks after the intervention
Endothelial function, assessed as reactive hyperemia indexup to 12 weeks after the intervention
mTOR signaling (phospho-S6 content) in circulating monocytesup to 12 weeks after the intervention
Postprandial plasma glucose concentrationup to 12 weeks after the intervention
Postprandial plasma insulin concentrationup to 12 weeks after the intervention

Countries

United States

Contacts

CONTACTBETTINA MITTENDORFER
b.mittendorfer@missouri.edu618-610-3465
PRINCIPAL_INVESTIGATORBettina Mittendorfer

University of Missouri-Columbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026