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PROTeIn-rich Meals to Control Glucose

PROTeIn-rich Meals to Control Glucose

Recruiting
18-75 years
All
Phase N/A

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Overview

The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status.

Description

Overweight individual with prediabetes and non-insulin treated type 2 diabetes will be recruited for the study. The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake - a high-protein (HP) breakfast and a high-carb (HC) dinner (HP/HC intervention) vs. a HC breakfast and a HP dinner (HC/HP intervention) - divided by a 4-week wash-out phase. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10E%protein, 60%E carbs, and 30%E fat.

Eligibility

Inclusion Criteria:

  • Prediabetes (fasting blood sugar 100-125 mg/dl)
  • Diabetes type 2 (fasting blood sugar >126 mg/dl)
  • Overweight and obesity (BMI 25-50 kg/m2)

Exclusion Criteria:

  • Other diabetes types
  • Insulin treatment
  • Shift work
  • Weight changes >5% within past 3 months
  • Systemic glucocorticoid therapy
  • Systemic infections
  • Severe anemia
  • High blood pressure (>180/110 mmHg)
  • Endocrinologic, liver and heart disorders
  • Immune diseases
  • Thyroid dysfunction
  • Heart attack or stroke
  • Cancer in the last 2 years
  • Eating disorders, food intolerance/allergy, addiction disorders, digestive disorders intestinal, liver, cardiovascular diseases
  • Hereditary or acquired coagulation disorders
  • Non-interruptible intake of blood thinners (anticoagulants)
  • Specific diets, intermittent fasting
  • Pregnancy or breastfeeding
  • Severe internal or psychiatric disorders or other conditions and drugs therapy that might influence the outcome of the study

Study details
    Overweight
    Obesity
    Prediabetes
    Type 2 Diabetes

NCT06382480

German Institute of Human Nutrition

3 May 2024

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