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Набор скоро начнётся NCT06911918

The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old

Без фазы С лечением Insulin Resistance Inflammation Biomarkers Time Restricted Eating Caloric Restriction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: time restricted eating with caloric restriction, time restricted eating without caloric restriction, Caloric restriction without Time restricted eating, No time restricted eating - Normal diet.
Кому может быть актуально
Состояния в реестре: Insulin Resistance, Inflammation Biomarkers, Time Restricted Eating, Caloric Restriction. Базовые параметры: 18 лет — 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Иордания
Следующий шаг
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Официальное название

The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old: A Randomized Control Study

Обзор

Obesity, a global epidemic, significantly contributes to prediabetes, cardiovascular diseases, and other chronic diseases due to its pro-inflammatory nature. This studyl investigates the effects of time-restricted eating (TRE) with calorie restriction (CR), TRE without CR, and CR without TRE on glycemic control and pro-inflammatory biomarkers among prediabetic obese Jordanian adults aged 18-40 years. The study assesses changes in pro-inflammatory biomarkers (IL-1β, TNF-α, IL-6), insulin resistance (HOMA-IR), and body composition over 12 weeks. Participants (n=120) will be randomized into four intervention arms: (1) TRE with CR, (2) TRE without CR, (3) CR without TRE, and (4) a control group with no dietary restrictions and no TRE. Biweekly anthropometric assessments will evaluate pro-inflammatory biomarkers and biochemical measures at baseline and the end of the study. The findings will provide insights into the comparative effectiveness of TRE and CR, potentially offering a safe, cost-effective intervention to prevent obesity-induced inflammation, prediabetes, and progression to type 2 diabetes mellitus.

Вмешательства

  • Другое time restricted eating with caloric restriction
    will be asked to reduce their energy intake by 550 each day. Total energy expenditure will be calculated using the Bioelectrical impedance (BIA); Inbody 120 and multiplied by the physical activity factor and reduced by 550 kilo calories for each participant. The acceptable macronutrient distribution range (AMDR) will be 45-60% carbohydrates, 15-25% protein, and 20-30% fat of the total caloric value and fasted from 18:00 to 8:00 daily (a 14-h fast) in the 12-weeks intervention
  • Другое time restricted eating without caloric restriction
    will be asked to maintain their normal diet to the acceptable normal distribution ranges and fast from 8:00 to 18:00. They do not need to restrict caloric intake during the feeding window
  • Другое Caloric restriction without Time restricted eating
    will be asked to reduce their energy intake by 550 each day. Total energy expenditure will be calculated using the Bioelectrical impedance (BIA); Inbody 120 and multiplied by the physical activity factor and reduced by 550 kilo calories for each participant. The acceptable macronutrient distribution range (AMDR) will be 45-60% carbohydrates, 15-25% protein, and 20-30% fat of the total caloric value
  • Другое No time restricted eating - Normal diet
    will be asked to maintain their normal diet as the second intervention arm without time restricted eating throughout the trial

Первичные конечные точки

  • Serum of TNF-α, IL-1β and IL-6 [Срок оценки: baseline and after 12 weeks of intervention]
Вторичные конечные точки (8)
  • Homa-IR [Срок оценки: baseline and after 12 weeks of intervention]
  • Lipid profile (LDL, HDL, TG, and cholesterol) [Срок оценки: baseline and after 12 weeks of intervention]
  • body weight [Срок оценки: baseline and every 2 weeks until 12 weeks of intervention]
  • Dietary intake using food records [Срок оценки: week4, week 8, and week 12 week]
  • Fasting blood glucose [Срок оценки: baseline and after 12 weeks of intervention]
  • fasting insulin level [Срок оценки: baseline and after 12 weeks of intervention]
  • height [Срок оценки: baseline]
  • Body composition [Срок оценки: baseline and every 2 weeks until 12 weeks of intervention]

Критерии участия

Критерии включения

  • IR individuals diagnosed with IR by the physicians as indicated by HOMA-IR score
  • female and male, BMI ≥ 30 to 39.9 kg/m2
  • age between 18 and 40 years
  • stable weight for 3 months before the beginning of the study
  • sedentary lifestyle

Критерии исключения

  • previous weight loss surgery
  • pregnancy or intent to become pregnant
  • breastfeeding
  • chronic diseases
  • drug therapies that could interfere with the effectiveness of the dietary intervention (e.g., use of corticosteroids, and anti-diabetic drugs)
  • diabetic type 1 and 2 individuals
  • anyone physically active to reduce the influence of confounding covariates

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Иордания · 1 центр
  • Najd Nutri Center — Amman

Идентификаторы

NCT: NCT06911918 · 382/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗