Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-04-12
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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HP/HC - HC/HP
Isocaloric 4-week HP/HC intervention followed by a 4-week HC/HP intervention.
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.
HC/HP - HP/HC
Isocaloric 4-week HC/HP intervention followed by a 4-week HP/HC intervention.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Diabetes type 2 (fasting blood sugar \>126 mg/dl)
* Overweight and obesity (BMI 25-50 kg/m2)
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Helmholtz Center Munich
UNKNOWN
Hasso Plattner Institute, Potsdam, Germany
UNKNOWN
German Institute of Human Nutrition
OTHER
Responsible Party
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Olga Ramich (formerly Pivovarova)
Head of Research Group Molecular Nutritional Medicine
Principal Investigators
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Olga Ramich, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
German Institute of Human Nutrition
Locations
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Olga Ramich
Potsdam, Potsdam-Rehbrücke, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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90/2023
Identifier Type: -
Identifier Source: org_study_id
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