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Clinical Trials in Germany / NCT06382480
Active, not recruiting Not applicable

PROTeIn-rich Meals to Control Glucose

NCT06382480 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2024-04-12
Last updated
2026-08-11

Condition(s) studied

OverweightObesityPrediabetesType 2 Diabetes

Investigational drug(s) / intervention(s)

Diet with specific macronutrient composition.

Diet with specific macronutrient composition.: The intervention is about an isocaloric diet that differs in terms of distribution of carbohydrates and protein throughout the day. The interventions include a HP-breakfast and a HC-dinner vs. a HC-breakfast and a HP-dinner. 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 10%E protein, 60%E carbs, and 30%E fat.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Olga Ramich Potsdam Potsdam-Rehbrücke

More German Institute of Human Nutrition trials in Germany

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06382480 on ClinicalTrials.gov ↗ ← All trials in Germany