Comparing effects of whey and casein protein on liver fat and metabolism
Molke Oder Casein - Leberfettreduktion Und Stoffwechselverbesserung Durch Schnelle vs. Langsame Proteine (Whey or Casein - Liver Fat Reduction and Metabolic Improvement by Fast vs. Slow Proteins)
This study tests whether eating whey or casein protein can help people with Type 2 Diabetes and fatty liver disease improve their liver fat and blood sugar levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT04564391 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of high-protein diets, specifically comparing whey and casein proteins, on liver fat content and glucose metabolism in individuals with Type 2 Diabetes and non-alcoholic fatty liver disease (NAFLD). The research aims to determine whether slowly-digestible proteins lead to better metabolic outcomes compared to fast-digestible proteins. Participants will undergo a 3-week dietary intervention, with assessments of liver fat and glucose metabolism conducted before and after the intervention. The study will involve 80 subjects and will utilize MR spectroscopy to measure liver fat content.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-79 with Type 2 Diabetes and NAFLD.
Not a fit: Patients with Type 1 diabetes, prediabetes, or those currently receiving insulin treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that improve metabolic health and reduce liver fat in patients with Type 2 Diabetes and NAFLD.
How similar studies have performed: Previous studies have shown promising results for high-protein diets in improving metabolic health, but this specific comparison of whey and casein is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin
- Charité Campus Benjamin Franklin — Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Stefan Kabisch, M.D.
- Email: Stefan.kabisch@charite.de
- Phone: +4930 450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.