PROTeIn-rich Meals to Control Glucose

NCT06382480 | Recruiting

• 1 other identifier: 90/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Obesity; Prediabetes; Type 2 Diabetes

Keywords

Glucose; Overweight; Obesity; Prediabetes; Type 2 Diabetes; Metabolism; Chrononutrition; Macronutrient composition; High-protein; High-carb; Isocaloric diet; Prevention and treatment of type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Mean 24-hour glucose

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

  4 weeks

Secondary Outcomes (19)

• Measurement of height

  4 weeks

• Measurement of body weight

  4 weeks

• Waist and hip circumference / waist to hip ratio

  4 weeks

• Systolic and diastolic blood pressure

  4 weeks

• Body fat and lean mass

  4 weeks

Study Arms (2)

HP/HC - HC/HP

EXPERIMENTAL

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

Other: Diet with specific macronutrient composition.

HC/HP - HP/HC

EXPERIMENTAL

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

Other: Diet with specific macronutrient composition.

Interventions

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.

HC/HP - HP/HC; HP/HC - HC/HP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• German Institute of Human Nutrition: lead
• Charite University, Berlin, Germany: collaborator
• Helmholtz Center Munich: collaborator
• Hasso Plattner Institute, Potsdam, Germany: collaborator

Study Sites (1)

Olga Ramich

Potsdam, Potsdam-Rehbrücke, 14558, Germany

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Prediabetic State; Diabetes Mellitus, Type 2

Interventions

Diet

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Olga Ramich, PD Dr.

  German Institute of Human Nutrition

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Ramich, PD Dr.

CONTACT

+4933200882749; olga.ramich@dife.de

Marina D´Urso

CONTACT

+4933200882690; marina.durso@dife.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Group Molecular Nutritional Medicine

Model Details: 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 divided by a 4-week wash-out phase.

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 24, 2024
• Study Start: April 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)