RecruitingNot ApplicableNCT06382480

PROTeIn-rich Meals to Control Glucose

Meal Timing-based Strategies to Improve Glucose Metabolism in Prediabetes and Type 2 Diabetes


Sponsor

German Institute of Human Nutrition

Enrollment

30 participants

Start Date

Apr 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • 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 Criteria19

  • 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

Interventions

OTHERDiet 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.


Locations(1)

Olga Ramich

Potsdam, Potsdam-Rehbrücke, Germany

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NCT06382480


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