Меню
Набор скоро начнётся NCT07423884

Effect of a Low-Calorie MCT-Rich Traditional Minangkabau Diet on Obese Individuals

Без фазы С лечением Metabolically Unhealty Obese Dyslipidemia Diabetes (DM) Resistance, Insulin

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: Low-Calorie Diet Rich in Medium-Chain Triglycerides (MCTs) Based on Traditional Minangkabau Foods.
Кому может быть актуально
Состояния в реестре: Metabolically Unhealty Obese, Dyslipidemia, Diabetes (DM), Resistance, Insulin. Базовые параметры: от 18 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
Индонезия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of a Low-Calorie Diet Rich in Medium-Chain Triglycerides Based on Traditional Minangkabau Foods on Lipid Profile, Leptin Levels, and DNA Methylation of the Leptin Gene Promoter in Individuals With Obesity

Обзор

This study aims to investigate the effect of a low-calorie diet rich in medium-chain triglycerides (MCTs) based on traditional Minangkabau foods on metabolic biomarkers in individuals with obesity. The traditional Minangkabau foods used in this study consist primarily of coconut milk-based dishes, which contain coconut oil as a natural source of MCTs. The metabolic biomarkers assessed include body mass index (BMI), waist circumference, systolic and diastolic blood pressure, body fat percentage, fasting blood glucose levels, lipid profile, leptin concentrations, and DNA methylation of the leptin gene promoter. Based on these metabolic biomarker measurements, participants will be classified into metabolic obesity phenotypes, namely metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUHO). The researchers hypothesize that the provision of a low-calorie, MCT-rich diet based on traditional Minangkabau foods will have a significant effect on metabolic biomarkers and metabolic status in individuals with obesity.

Подробное описание

This study was conducted within the Faculty of Medicine and the Faculty of Public Health at Andalas University, Padang, and received ethical approval from the Research Ethics Committee of the Faculty of Medicine, Andalas University. The study population consisted of educational staff with a body mass index (BMI) greater than 25 kg/m². Study participants were educational staff who agreed to participate and provided written informed consent. A total of 40 participants were included in the study, comprising 20 participants in the intervention group and 20 participants in the control group.

The study was conducted over a period of 12 weeks (90 days). One week prior to the intervention, dietary intake was assessed using the 24-hour food recall method. Anthropometric measurements were performed using calibrated instruments by trained personnel.

Participants in both the intervention and control groups underwent a one-week pre-intervention period (baseline period, from day -6 to day 0), during which they were instructed not to consume any supplements. Anthropometric measurements, blood pressure, body fat percentage, fasting blood glucose levels, lipid profile, leptin concentrations, and DNA methylation of the leptin gene promoter were assessed on day 0 and day 90.

Dietary intake data obtained from the 24-hour food recall interviews were analyzed using the NutriSurvey 2005 software. The dietary intervention was designed to provide an energy deficit of 500-600 kcal compared with participants' habitual daily intake. The diet was based on traditional Minangkabau foods.

Participants in the intervention group were provided with daily menu plans for breakfast, lunch, and dinner. The dietary intervention was prepared independently by participants in accordance with the dietary guidelines and menus provided. In contrast, the control group followed a standard nutritionally balanced diet according to individual requirements. Participants were instructed to record their daily food intake in a food diary, which was collected and evaluated twice weekly (on weekdays and weekends). In addition, the research team monitored and motivated all participants through WhatsApp groups. Data analysis was performed using SPSS software.

Вмешательства

  • Другое Low-Calorie Diet Rich in Medium-Chain Triglycerides (MCTs) Based on Traditional Minangkabau Foods
    Participants in the intervention group received a nutritionally balanced low-calorie diet rich in medium-chain triglycerides (MCTs) derived from traditional Minangkabau foods. The dietary intervention was designed to provide an energy deficit of 500-600 kcal compared with participants' habitual daily intake. Assessments were conducted before and after the intervention period.

Первичные конечные точки

  • Change from baseline in body mass index (BMI). [Срок оценки: After 12 weeks]
  • Change from baseline in waist circumference. [Срок оценки: After 12 weeks]
  • Change from baseline in body fat percentage [Срок оценки: After 12 weeks]
  • Change from baseline in systolic and diastolic blood pressure [Срок оценки: After 12 weeks]
  • Change from baseline in fasting blood glucose levels. [Срок оценки: After 12 weeks]
  • Change from baseline in lipid profile. [Срок оценки: After 12 weeks]
  • Change from baseline in serum leptin. [Срок оценки: After 12 weeks]
  • Change from baseline in DNA methylation of the leptin gene promoter. [Срок оценки: After 12 weeks]
Вторичные конечные точки (1)
  • Change in metabolic status. [Срок оценки: After 12 weeks]

Критерии участия

Критерии включения

  • Administrative staff of the Faculty of Medicine and the Faculty of Public Health, Andalas University, Padang, with obesity defined as a body mass index (BMI) ≥ 25 kg/m².
  • Willing to participate in the study by providing written informed consent.
  • Participants with obesity classified as Metabolically Unhealthy Obese (MUHO)

Критерии исключения

  • Did not come and could not be found at the time of research data collection
  • Unable to follow the dietary arrangements as set
  • Taking anti-diabetic or anti-lipid drugs
  • Use of contraceptives or hormonal drugs
  • In the treatment of radiotherapy or chemotherapyi
  • Participants with obesity classified as Metabolically Healthy Obese (MHO)

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

Индонезия · 1 центр
  • Prof. Nur Indrawaty Lipoeto — Padang

Публикации

  • Lipoeto, N.I., Elliyanti, A. and Febri, D.S. (2025) 'The Effect of A Low-Calorie Balanced Nutrition Diet Based on Minang Cuisine in Obese Patients', 10(February), pp. 26-34.
  • Lipoeto NI, Agus Z, Oenzil F, Wahlqvist M, Wattanapenpaiboon N. Dietary intake and the risk of coronary heart disease among the coconut-consuming Minangkabau in West Sumatra, Indonesia. Asia Pac J Clin Nutr. 2004;13(4):377-84. PMID 15563444

Идентификаторы

NCT: NCT07423884 · PMDSU2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗