Animal and Plant Proteins and Glucose Metabolism

Обзор

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.

Вмешательства

• Другое High animal protein isolate
  Increased dietary protein content from animal protein isolates
• Другое High animal protein whole food
  Increased dietary protein content from animal protein whole food
• Другое High plant protein isolate
  Increased dietary protein content from plant protein isolates
• Другое High plant protein whole food
  Increased dietary protein content from animal protein whole food

Первичные конечные точки

• 24-hour plasma glucose concentration [Срок оценки: up to 12 weeks after the intervention]
• Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure [Срок оценки: up to 12 weeks after the intervention]

Вторичные конечные точки (5)

• Postprandial plasma glucose concentration [Срок оценки: up to 12 weeks after the intervention]
• mTOR signaling (phospho-S6 content) in circulating monocytes [Срок оценки: up to 12 weeks after the intervention]
• Endothelial function, assessed as reactive hyperemia index [Срок оценки: up to 12 weeks after the intervention]
• Postprandial plasma insulin concentration [Срок оценки: up to 12 weeks after the intervention]
• Postprandial plasma amino acid concentration [Срок оценки: up to 12 weeks after the intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Missouri School of Medicine — Columbia

Идентификаторы

NCT: NCT03994367 · 2097498

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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