Time-restricted Feeding in MASLD

Официальное название

The Impact of Time-restricted Feeding on Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

Обзор

The recommended treatment for metabolic dysfunction-associated steatotic liver disease (MASLD) currently focuses on lifestyle changes, including dietary adjustments and increased physical activity. Intermittent fasting is a specific dietary approach in which food intake is restricted for certain periods. Recent scientific evidence suggests that intermittent fasting can positively influence body weight, insulin resistance, and markers of inflammation. This study will examine whether restricting energy intake to approximately 600 kcal on two days per week has beneficial effects on MASLD. The nutritional framework is based on the guidelines of the German Nutrition Society (DGE) for a healthy diet (10 rules for healthy eating). Following a two-week introduction to these DGE recommendations, participants will be randomly assigned to one of two treatment groups. In the intervention group, participants follow a 5:2 intermittent fasting regimen, eating without restrictions on five days per week and limiting intake to about one-quarter of their usual daily energy (≈600 kcal) on two non-consecutive days. In the control group, participants follow a healthy diet according to DGE guidelines without restrictions on timing or energy intake.

Вмешательства

• Поведенческое time-restricted feeding in a 5:2 regimen
  Participants in the intervention group follow a 5:2 intermittent fasting regimen, consisting of two non-consecutive days per week with a reduced energy intake of approximately 600 kcal, while on the remaining five days they adhere to a balanced diet in accordance with the recommendations of the German Nutrition Society (DGE).

Первичные конечные точки

• Reduction of controlled attenuation parameter (CAP) [Срок оценки: from enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (12)

• Improvement in liver stiffness measurment (LSM) [Срок оценки: from enrollment to the end of treatment at 12 weeks]
• Improvement in CLDQ-NAFLD/NASH for liver-specific quality of life [Срок оценки: from enrollment to the end of treatment at 12 weeks]
• Change in insulin sensitivity (HOMA-IR) [Срок оценки: from enrollment to the end of treatment at 12 weeks]
• Changes in the gut microbiome [Срок оценки: from enrollment to the end of treatment at 12 weeks]
• Reduction of skin AGE [Срок оценки: from enrollment to the end of treatment at 12 weeks]
• Number of participants with selected genetic variants at baseline [Срок оценки: baseline]
• Change in proportion fo circulating immune cell subsets [Срок оценки: from enrollment to the end of treatment at 12 weeks]
• Change in fasting plasma glucose [Срок оценки: From enrollment to end of treatment at 12 weeks]
• Change in LDL cholesterol [Срок оценки: From enrollment to end of treatment at 12 weeks.]
• Change in HDL cholesterol [Срок оценки: From enrollment to end of treatment at 12 weeks.]
• Change in triglycerides [Срок оценки: From enrollment to end of treatment at 12 weeks.]
• Change in blood pressure [Срок оценки: From enrollment to end of treatment at 12 weeks.]

Критерии участия

Критерии включения

• 18 and 75 years
• Body mass index (BMI) > 25 kg/m²
• MASLD grade 3 with CAP ≥ 280 dB/m, excluding liver damage
• Liver stiffness < 13 kPa
• Ability to understand the study and the individual consequences of participating in the study
• Signed and dated consent form before the start of any study activity

Критерии исключения

• Hepatocellular carcinoma or non-curatively treated carcinomas
• Alcohol consumption >20 g (women) and >30 g (men) per day
• Other liver diseases (HBV, HCV, HDV, HEV, HIV), autoimmune diseases or chronic cholestatic liver disease, hereditary haemochromatosis, Wilson's disease, α-1-antitrypsin deficiency
• Medications that cause liver disease or secondary NAFLD (e.g. tamoxifen, systemic corticosteroids, methotrexate, tetracyclines, oestrogens, valproic acid)
• Body weight changes of > 5% in the last 6 months
• Statins and/or other lipid-lowering drugs, if these have not been taken in a stable dose for at least 4 weeks
• Uncontrolled type 2 diabetes defined as HbA1c value > 9.0% or insulin-dependent type 2 diabetes
• Pregnancy
• Immunological or inflammatory diseases (e.g. systemic lupus erythematosus)
• Following a restrictive, special diet
• Patients who have undergone organ transplants
• Lack of or absence of capacity to give consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Department of Internal Medicine II, Saarland University Medical Center, Saarland Universit — Homburg

Идентификаторы

NCT: NCT07530809 · 100/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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