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Набор скоро начнётся NCT07111767

Effectiveness of a Modified Cost-Effective Dietary Plan in Promoting Weight Loss and Preservation of Lean Body Mass in Patients After Bariatric Surgery

Без фазы С лечением Obesity Bariatric Surgery Nutritional Status Body Composition

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-Cost Post-Bariatric Diet, Standard High-cost Post-Bariatric Diet.
Кому может быть актуально
Состояния в реестре: Obesity, Bariatric Surgery, Nutritional Status, Body Composition. Базовые параметры: 18 лет — 65 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
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study will see if a low-cost dietary plan, based on the standard dietary guidelines of the American Society for Metabolic and Bariatric Surgery (ASMBS) and using locally available foods, can help patients lose weight and keep their lean body mass after bariatric surgery. It will also check if this plan can maintain healthy levels of important nutrients such as vitamin B12, iron, and vitamin D. Patients who have undergone bariatric surgery will be randomly assigned to follow either the low-cost diet or the regular hospital diet. Their weight, body composition, and nutrient levels will be tracked at baseline, and at 1, 3, and 6 months after surgery. The aim is to find out if this simpler, affordable diet, which follows international standards, works as well as the regular plan while being easier for low-income patients to follow.

Подробное описание

Obesity is a growing global health problem and is recognized by the World Health Organization (WHO) as a leading cause of preventable disease. It is a complex, long-term condition influenced by multiple factors, and treatment options range from lifestyle changes to medications and surgery. Bariatric surgery is currently the most effective long-term treatment for morbid obesity. It not only helps in significant weight loss but also improves obesity-related health problems such as type II diabetes, hypertension, and obstructive sleep apnea, while improving quality of life.

Among the various surgical techniques, Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and one-anastomosis gastric bypass (OAGB/MGB) are the most commonly performed. However, these surgeries can lead to reduced absorption of essential nutrients because they bypass parts of the intestine where vitamins and minerals are absorbed. Nutrient deficiencies, particularly in vitamin B12, iron, and vitamin D, are common after bariatric surgery. Therefore, structured dietary management and supplementation are essential after surgery to prevent these deficiencies and preserve lean body mass (LBM).

Standard dietary recommendations from the American Society for Metabolic and Bariatric Surgery (ASMBS) suggest a gradual progression from liquids to solid foods, adequate protein intake (1.0-1.5 g/kg), and lifelong use of vitamin and mineral supplements. However, in countries like Pakistan, where 45% of the population lives below the international poverty line, the standard postoperative diet often includes costly imported supplements like whey protein, which are unaffordable and hard to access for most patients, particularly those from rural areas. This creates barriers to dietary compliance and worsens clinical outcomes.

Adequate protein intake plays a key role in preserving lean body mass and improving recovery after bariatric surgery. Nutritional deficiencies, particularly in vitamin B12, iron, and vitamin D, remain prevalent after bariatric surgery and require targeted nutritional strategies.

In response to these challenges, this study introduces a low-cost dietary plan based on ASMBS guidelines using locally available, affordable foods to meet protein and micronutrient needs. It aims to compare this plan with the conventional high-cost hospital diet to determine whether it can effectively promote weight loss, maintain lean body mass, and prevent micronutrient deficiencies. By aligning with international standards while addressing local socioeconomic constraints, this approach could improve patient adherence, nutritional outcomes, and overall recovery following bariatric surgery.

Вмешательства

  • Пищевая добавка Low-Cost Post-Bariatric Diet
    Low-Cost Post-Bariatric Diet (Experimental): Based on the American Society for Metabolic and Bariatric Surgery (ASMBS) guidelines. Uses affordable, locally available foods (e.g., eggs, lentils, local dairy products) to meet protein and micronutrient needs. Designed to be cost-effective and accessible for patients from low-income or rural areas.
  • Пищевая добавка Standard High-cost Post-Bariatric Diet
    Standard Post-Bariatric Diet (Active Comparator): The conventional high-cost diet currently followed at the study hospital. Includes imported or expensive protein supplements such as whey protein and cottage cheese, along with nutritional products not easily accessible in rural or low-resource settings.

Первичные конечные точки

  • Weight Loss [Срок оценки: Baseline, 1 month, 3 months, and 6 months after surgery.]
Вторичные конечные точки (5)
  • Change in Serum Iron Levels [Срок оценки: Baseline, 1 month, 3 months, and 6 months post-surgery.]
  • Change in Serum Vitamin B12 Levels [Срок оценки: Baseline, 1 month, 3 months, and 6 months post-surgery.]
  • Change in Serum Vitamin D Levels [Срок оценки: Baseline, 1 months, 3 months, and 6 months post-surgery.]
  • Lean Body Mass (LBM) [Срок оценки: Baseline, 1 month, 3 months, and 6 months postoperatively]
  • Body Mass Index (BMI) [Срок оценки: Baseline, 1 month, 3 months, and 6 months postoperatively]

Критерии участия

Критерии включения

  • Able to give informed written consent
  • Adults between the ages of 18 and 65 undergoing primary bariatric surgery (Roux-en-Y gastric bypass, sleeve gastrectomy, or OAGB)

Критерии исключения

  • Patients having revision bariatric surgery
  • Patients with recognized diseases related to micronutrient supplementation
  • Patients with pre-existing gastrointestinal, metabolic, or endocrine disorders that impair nutrient absorption

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
Открытое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • Khyber Teaching Hospital — Peshawar

Публикации

  • Via MA, Mechanick JI. Nutritional and Micronutrient Care of Bariatric Surgery Patients: Current Evidence Update. Curr Obes Rep. 2017 Sep;6(3):286-296. doi: 10.1007/s13679-017-0271-x. PMID 28718091

Идентификаторы

NCT: NCT07111767 · 661/DME/KMC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗