Weight Loss Composition and Metabolic Adaptation During Hypocaloric Dieting
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: Hypocaloric Diet.
- Кому может быть актуально
- Состояния в реестре: Obesity. 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Relationship Between Weight Loss Composition, Body Composition Changes, and Metabolic Adaptation During a Hypocaloric Dietary Intervention
Обзор
Weight loss induced by hypocaloric dietary interventions is commonly accompanied by reductions in resting metabolic rate (RMR), a phenomenon often described as metabolic adaptation. The magnitude of this decline varies substantially between individuals and may depend not only on the amount of weight lost but also on the composition of weight loss, particularly the relative contributions of fat mass and fat-free mass. This prospective interventional study will investigate whether changes in body composition during a hypocaloric dietary intervention are associated with changes in RMR and metabolic adaptation. Approximately 150 adults with overweight or obesity will participate in a structured dietary program designed to induce moderate energy restriction. Body composition and resting metabolic rate will be assessed before and after the intervention to evaluate associations between fat mass loss, fat-free mass loss, and metabolic responses to weight reduction.
Подробное описание
Weight loss achieved through caloric restriction is consistently associated with reductions in resting metabolic rate (RMR). In many individuals, the decrease in energy expenditure exceeds what would be predicted from the loss of body mass or body composition alone, a phenomenon commonly described as metabolic adaptation or adaptive thermogenesis. This response has been proposed as one potential contributor to the difficulty many individuals experience in maintaining weight loss over time.
Fat-free mass is the primary determinant of resting energy expenditure because it includes metabolically active tissues such as skeletal muscle and organs. Consequently, the relative proportion of fat mass and fat-free mass lost during weight reduction may influence the magnitude of RMR decline. Dietary strategies that promote preservation of fat-free mass, such as adequate protein intake and engagement in physical activity, may attenuate metabolic slowing during weight loss. However, substantial inter-individual variability in metabolic responses to weight loss has been reported, and the role of weight-loss composition in shaping these responses remains incompletely understood.
The present study aims to examine the relationship between changes in body composition and changes in resting metabolic rate during a structured hypocaloric dietary intervention in adults with overweight or obesity. Participants will follow individualized dietary plans designed to produce a moderate energy deficit. Body composition will be assessed using dual-energy X-ray absorptiometry (DXA), and resting metabolic rate will be measured using indirect calorimetry at baseline and following completion of the intervention. Anthropometric measures and physical activity patterns will also be recorded.
By evaluating the relative contributions of fat mass loss and fat-free mass loss to changes in energy expenditure, this study aims to improve understanding of the physiological responses to weight reduction. The findings may help inform weight-loss strategies designed to minimize unfavorable metabolic adaptations and support more sustainable long-term weight management.
Вмешательства
- Поведенческое Hypocaloric Diet
Participants will follow individualized dietary plans designed to produce an energy deficit of approximately 500-600 kcal/day relative to measured resting metabolic rate. Protein intake will be prescribed at approximately 1.5 g/kg body weight per day to support preservation of fat-free mass. Dietary plans will be adjusted as needed during the intervention period, and participants will attend regular follow-up visits to monitor progress and adherence.
Первичные конечные точки
- Change in Resting Metabolic Rate [Срок оценки: Baseline to end of dietary intervention (up to 12 months)]
Вторичные конечные точки (6)
- Change in Fat Mass [Срок оценки: Baseline to end of dietary intervention (up to 12 months)]
- Change in Fat-Free Mass [Срок оценки: Baseline to end of dietary intervention (up to 12 months)]
- Change in Body Weight [Срок оценки: Baseline to end of dietary intervention (up to 12 months)]
- Change in Abdominal Circumference [Срок оценки: Baseline to end of dietary intervention (up to 12 months)]
- Intervention Duration [Срок оценки: Baseline to end of intervention (up to 12 months)]
- Physical Activity Modality [Срок оценки: Baseline to end of dietary intervention (up to 12 months)]
Критерии участия
Критерии включения
- Adults aged 18 years and older.
- Individuals living with overweight or obesity.
- Willingness and ability to comply with dietary recommendations and study procedures.
- Provision of written informed consent.
Критерии исключения
- Diagnosed metabolic or endocrine disorders known to affect energy expenditure.
- Use of medications known to substantially affect metabolism or body composition.
- Pregnancy or breastfeeding.
- Any medical condition that, in the opinion of the investigators, precludes safe participation.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07627256 · 0012134-2