RecruitingNot ApplicableNCT04564391

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

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)


Sponsor

Charite University, Berlin, Germany

Enrollment

80 participants

Start Date

Sep 21, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

High-protein diets have been recently demonstrated to effectively reduce insulin resistance, derangements of the lipid profile and liver fat content in subjects with moderately and severely impaired glucose metabolism and non-alcoholic fatty liver disease (LeguAN, LEMBAS, DiNA-P, DiNA-D). The effects can be attributed to prolonged insulin secretion and improved second meal effect, higher energy expenditure by urea synthesis, suppression of glucagon or other mechanisms. Up to now, it is unclear, if proteins with slower or faster digestibility lead to differential results in these study designs. The proposed study will elucidate this question. The Investigators hypothesize, that slowly-digestible proteins induce a prolonged insulin plateau supporting the second-meal effect. The investigators also assume, that these dietary proteins lead to a markedly stronger short-term secretion of glucagon followed by desensitisation of this hormone release. Fast-digestible proteins, on the other hand, will presumably induce a smaller second-meal effect and do not inhibit a second rise of glucagon in a consecutive meal. The investigators intend to study the effects of a 3-weeks high-protein diet in 80 subjects with NAFLD and T2DM on liver fat content (MR spectroscopy) and glucose metabolism. The investigators expect different results for slow protein (casein) and fast protein (whey), thus comparing both protein species. The two major clinical visits before and after the intervention period will include MRI spectroscopy, fasting blood sampling for later analysis, full anthropometric assessment, a mixed meal tolerance test and a set of behavioral tests, investigating decision making processes. In order to characterize the postprandial profiles (e.g. insulin, glucagon, amino acids) of the varying protein sources, preliminary meal tests are performed in overweight subjects with and without T2DM.


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study compares the effects of two types of protein — whey (fast-digesting) and casein (slow-digesting) — on liver fat and blood sugar control in overweight adults with or without type 2 diabetes. Excess liver fat is a common and serious condition often linked to obesity and diabetes. **You may be eligible if...** - Subcohort 1: You are between 40-79 years old, overweight or obese, with normal blood sugar or type 2 diabetes - Subcohort 2: You are between 18-79 years old, have type 2 diabetes, and have fatty liver disease (NAFLD) **You may NOT be eligible if...** - You have type 1 diabetes or prediabetes - You are currently taking insulin - You are lactose intolerant or allergic to dairy products - You have severe heart, lung, gastrointestinal, or psychiatric conditions - You have had an active cancer recently - You take steroids or medications that affect blood sugar - You are pregnant or breastfeeding - You have claustrophobia (Subcohort 2 only, due to MRI) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTprotein supplement

protein supplement, daily 60 g of protein, 3 weeks of intervention; blinded to patients

DIETARY_SUPPLEMENTplacebo supplement

Placebo supplement, daily intake of placebo, 3 weeks of intervention; blinded to patients


Locations(1)

Charité Campus Benjamin Franklin

Berlin, Germany

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NCT04564391


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