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PROTeIn-rich Meals to Control Glucose

ConditionsOverweightObesityPrediabetesType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGerman Institute of Human Nutrition

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Other diabetes types

Insulin treatment

Shift work

Weight changes >5% within past 3 months

Trial design

Design model

Crossover

Treatments tested in this trial

  • Diet with specific macronutrient composition.

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: HP/HC - HC/HPExperimental treatment 1 intervention
Group B: HC/HP - HP/HCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean 24-hour glucose

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

Time frame
4 weeks

Secondary outcomes

1

Measurement of height

Height measured by stadiometer

Time frame
4 weeks
2

Measurement of body weight

Body weight measured by body scale

Time frame
4 weeks
3

Waist and hip circumference / waist to hip ratio

Waist and hip circumference measured by tape measure

Time frame
4 weeks
4

Systolic and diastolic blood pressure

Systolic and diastolic blood pressure changes measurement by manometer

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

German Institute of Human Nutrition

Lead sponsor

Charite University, Berlin, Germany

Collaborator

Helmholtz Center Munich

Collaborator

Hasso Plattner Institute, Potsdam, Germany

Collaborator

Source ClinicalTrials.gov
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