Clinical trial

PROTeIn-rich Meals to Control Glucose

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06382480

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionOverweight, Obesity, Prediabetes, Type 2 Diabetes

Full registry 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

Treatments and study arms

Diet with specific macronutrient composition.

Other

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.

Primary outcomes

Mean 24-hour glucose4 weeks

Mean 24-hour glucose assessed by continuous glucose monitoring (CGM)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Olga Ramich🇩🇪 Potsdam, Potsdam-Rehbrücke, Germany

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