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Search / Trial NCT04564391

Whey or Casein - Liver Fat Reduction and Metabolic Improvement by Fast vs. Slow Proteins

Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · Sep 21, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Nafld Type 2 Diabetes Whey Protein Casein Second Meal Effect Pea Protein

ClinConnect Summary

This clinical trial is exploring how different types of protein—specifically, fast-digesting whey protein and slow-digesting casein protein—affect liver fat and sugar control in people with Type 2 Diabetes and non-alcoholic fatty liver disease (NAFLD). Researchers want to find out if one type of protein is more effective than the other in improving these health issues. They will be studying 80 participants over three weeks, measuring changes in liver fat and how the body processes sugar after meals.

To participate, individuals need to be between 18 and 79 years old and have Type 2 Diabetes along with NAFLD. There are some health conditions and medications that could exclude someone from joining, like having Type 1 Diabetes or certain severe disorders. Participants will undergo various tests before and after the study, including MRI scans and blood tests, to track how their bodies respond to the different proteins. This trial will help us understand the potential benefits of protein types in managing diabetes and liver health.

Gender

ALL

Eligibility criteria

  • Subcohort 1 (n=46):
  • Inclusion Criteria:
  • healthy glucose levels or T2DM
  • 40-79 years
  • overweight/obesity
  • Main Exclusion Criteria:
  • type 1 diabetes, prediabetes
  • currently receiving treatment with insulin
  • lactose intolerance, or food intolerance/allergy to any of the study products
  • severe endocrine, gastrointestinal, metabolic, cardiovascular, pulmonary, inflammatory or psychiatric disorder
  • active or recent relevant cancer
  • intake of glucocorticoids or other medication that influences glucose metabolism
  • pregnancy, breastfeeding
  • Subcohort 2 (n=80):
  • Inclusion Criteria:
  • T2DM
  • with NAFLD
  • 18-79 years
  • Main Exclusion Criteria:
  • type 1 diabetes, prediabetes
  • currently receiving treatment with insulin
  • lactose intolerance, or food intolerance/allergy to any of the study products
  • severe endocrine, gastrointestinal, metabolic, cardiovascular, pulmonary, inflammatory or psychiatric disorder
  • active or recent relevant cancer
  • intake of glucocorticoids or other medication that influences glucose metabolism
  • pregnancy, breastfeeding
  • claustrophobia

About Charite University, Berlin, Germany

Charité - Universitätsmedizin Berlin is a leading academic medical center in Germany, renowned for its commitment to excellence in research, education, and patient care. As one of Europe's largest university hospitals, Charité integrates cutting-edge clinical practices with innovative research initiatives, fostering interdisciplinary collaboration across various medical fields. The institution is dedicated to advancing healthcare through rigorous clinical trials, contributing to the development of new therapies and treatment protocols. With a strong emphasis on translational medicine, Charité aims to bridge the gap between scientific discovery and practical application, ultimately enhancing patient outcomes and public health.

Locations

Berlin, , Germany

Patients applied

0 patients applied

Trial Officials

Andreas FH Pfeiffer, Prof. Dr.

Study Director

Charité Universitätsmedizinh Berlin

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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