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Recruiting NCT06382480

NCT06382480 PROTeIn-rich Meals to Control Glucose

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Clinical Trial Summary
NCT ID NCT06382480
Status Recruiting
Phase
Sponsor German Institute of Human Nutrition
Condition Overweight
Study Type INTERVENTIONAL
Enrollment 30 participants
Start Date 2024-04-12
Primary Completion 2026-12-31

Trial Parameters

Condition Overweight
Sponsor German Institute of Human Nutrition
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-04-12
Completion 2026-12-31
Interventions
Diet with specific macronutrient composition.

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Brief Summary

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.

Eligibility Criteria

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

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