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PROTeIn-rich Meals to Control Glucose

NCT06382480 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-26

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Helmholtz Center Munich

    collaborator UNKNOWN

  • Hasso Plattner Institute, Potsdam, Germany

    collaborator UNKNOWN

  • German Institute of Human Nutrition

    lead OTHER

Principal Investigators

  • Olga Ramich, PD Dr. · German Institute of Human Nutrition

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-12
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06382480 on ClinicalTrials.gov