Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD

Официальное название

Effects of Two Different Exercise Programs Combined With the Mediterranean Diet on Inflammatory Status in Subjects With Obesity and NAFLD

Обзор

The aim of the study is to estimate the effectiveness of two different exercise programs combined with the Mediterranean diet versus diet alone on inflammatory status in subjects aged 18-65 years with obesity (BMI\>30) and Non-Alcoholic Fatty Liver Disease (NAFLD) (CAP \>248 dB/m).

Подробное описание

The main objective of the study is to estimate the effect of two exercise programs of different type and intensity combined with a Low Glycaemic Index Mediterranean Diet (LGIMD) compared to diet alone on the systemic inflammation index (SII) and biomarkers related to the inflammatory state: TNF-alpha; IL-1, IL-6, IL-10, CK-18, PCR and VES, in patients with obesity and NAFLD aged 18-65 years after a 4-month intervention.

The secondary objectives are: to assess whether the adoption of the two exercise programs of different types and intensities associated with an LGIMD compared to diet alone in patients with obesity and NAFLD can significantly modify body composition, inhibiting the risk of sarcopenia, in turn, favored by NAFLD, improve physical efficiency (fitness), understood as cardio-respiratory fitness muscular strength and flexibility, may also lead to improvements regarding the gut microbiota, in terms of abundance of microbial taxa, by studying, starting from the data obtained from the 16S, the metabolic pathways of the microbiota and fecal metabolome, as well as Quality of Life, by filling in specific questionnaires, and the evaluation of the fatty acid profile of erythrocyte membranes.

The two different types of exercise will be: - outdoor walking, understood as a moderate-intensity aerobic exercise, carried out 4 times a week, for a duration of 60 minutes for 4 months; - High-Intensity Interval Training carried out 3 times a week, for a period of 50 minutes at a time for 4 months in a gymnasium affiliated with the organization.

The diet will be the same for all project participants and will follow advice based on the Low Glycaemic Index Mediterranean Diet. All subjects will be followed by specialized personnel regarding both diet and exercise.

Вмешательства

• Поведенческое Aerobic Exercise and diet intervention
  subjects randomized and assigned to one intervention group, will follow the low glycaemic index Mediterranean diet and simultaneously perform moderate-intensity aerobic exercises
• Поведенческое Hiit and diet intervention
  subjects randomised and assigned to one intervention group, will follow the low glycaemic index Mediterranean diet and simultaneously perform high-intensity interval exercises in the gym
• Поведенческое Diet
  subjects randomised and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet

Первичные конечные точки

• The effect of diet and exercise on systemic inflammatory status [Срок оценки: at baseline and day120]

Вторичные конечные точки (7)

• The effect of diet and exercise on body composition [Срок оценки: At baseline, day 60, and day 120]
• The effect of diet and exercise on the gut microbiota [Срок оценки: At baseline and day 120]
• The effect of diet and exercise on quality of life [Срок оценки: At baseline and day 120]
• The effect of diet and exercise on the fatty acid profile of erythrocyte membranes [Срок оценки: At baseline and day 120]
• The effect of diet and exercise on the risk of sarcopenia [Срок оценки: At baseline and day 120]
• The effect of diet and exercise on the peptides of Integrity Intestinal Barrier [Срок оценки: At baseline and day 120]
• The effect of diet and exercise on the Intestinal dysbiosis [Срок оценки: At baseline and day 120]

Критерии участия

Критерии включения

• BMI ≥ 30 kg/m2 or an abdominal circumference (waist) > 94 cm in men and > 80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the characteristics that characterise metabolic syndrome
• Age range 18-65 years, both sexes
• Diagnosis of hepatic steatosis, formulated on the basis of recognised criteria (fibroscan (CAP (controlled attenuation parameter) > 238 dB/m)).

Критерии исключения

• Normal and underweight subjects
• Presence of any pathology that may influence the presence of steatosis apart from pathologies that are inclusion criteria, neurological and psychiatric pathologies, gastrointestinal, oncological and cardiovascular diseases
• Pregnancy or breastfeeding
• Subjects with osteoarticular pathologies that may prevent regular exercise
• Inability to quantify the degree of NAFLD by Fibroscan
• Person not in possession of a medical certificate of fitness for non-competitive physical activity.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• IRCCS De Bellis — Castellana Grotte

Публикации

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• Calabrese FM, Disciglio V, Franco I, Sorino P, Bonfiglio C, Bianco A, Campanella A, Lippolis T, Pesole PL, Polignano M, Vacca M, Caponio GR, Giannelli G, De Angelis M, Osella AR. A Low Glycemic Index Mediterranean Diet Combined with Aerobic Physical Activity Rearranges the Gut Microbiota Signature in NAFLD Patients. Nutrients. 2022 Apr 23;14(9):1773. doi: 10.3390/nu14091773. PMID 35565740
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Идентификаторы

NCT: NCT06186869 · AF_001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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