PROTeIn-rich Meals to Control Glucose (PROTIME)

German Institute of Human Nutrition

Status: Enrolling

Conditions: Prediabetes; Overweight; Obesity; Type 2 Diabetes

Treatments: Other: Diet with specific macronutrient composition.

Study type: Interventional

Funder types: Other

Identifiers

NCT06382480

90/2023

Details and patient eligibility

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

HP/HC - HC/HP

Experimental group

Description:

Isocaloric 4-week HP/HC intervention followed by a 4-week HC/HP intervention.

Treatment:

Other: Diet with specific macronutrient composition.

HC/HP - HP/HC

Experimental group

Description:

Isocaloric 4-week HC/HP intervention followed by a 4-week HP/HC intervention.

Treatment:

Other: Diet with specific macronutrient composition.