Animal and Plant Proteins and Glucose Metabolism

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorUniversity of Missouri-Columbia

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • High animal protein isolate

    Other intervention

    Increased dietary protein content from animal protein isolates

  • High animal protein whole food

    Other intervention

    Increased dietary protein content from animal protein whole food

  • High plant protein isolate

    Other intervention

    Increased dietary protein content from plant protein isolates

  • High plant protein whole food

    Other intervention

    Increased dietary protein content from animal protein whole food

Treatment groups

100 Participants
are divided into 5 treatment groups
Group A: Standard protein (control)No intervention 0 interventions
Group B: High animal protein isolateExperimental treatment 1 intervention
Group C: High animal protein whole foodExperimental treatment 1 intervention
Group D: High plant protein isolateExperimental treatment 1 intervention
Group E: High plant protein whole foodExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

24-hour plasma glucose concentration

Time frame
up to 12 weeks after the intervention
2

Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure

Time frame
up to 12 weeks after the intervention

Secondary outcomes

1

Postprandial plasma glucose concentration

Time frame
up to 12 weeks after the intervention
2

mTOR signaling (phospho-S6 content) in circulating monocytes

Time frame
up to 12 weeks after the intervention
3

Endothelial function, assessed as reactive hyperemia index

Time frame
up to 12 weeks after the intervention
4

Postprandial plasma insulin concentration

Time frame
up to 12 weeks after the intervention

Other outcomes

Sponsors and contacts

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