Меню
Идёт набор NCT05843318

Water Intake and Weight Control in Older Adults

Без фазы С лечением Overweight and Obesity

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: Water intake and weight control in older adults - Premeal Water + hypocaloric diet, Water intake and weight control in older adults - Total Daily Water + hypocaloric diet, Water Intake and weight control in older adults - hypocaloric diet alone.
Кому может быть актуально
Состояния в реестре: Overweight and Obesity. Базовые параметры: от 50 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

This study is a randomized controlled intervention trial in adults aged 50+ years with overweight or obesity, which will compare three groups with different diet prescriptions: 1) pre-meal water consumption (500 ml, before each main meal) with a hypocaloric diet; 2) 1500 ml water consumed throughout the day with a hypocaloric diet; 3) hypocaloric diet with no instructions regarding water consumption. Smart water bottles will objectively assess water intake timing and volume. Urine osmolality, urine volume, and serum osmolality will be used as objective indicators of compliance with the water intake prescription. We will investigate changes in perceived hunger and fullness and appetite-regulating hormones as potential mechanisms by which premeal water could improve appetite regulation. We will also investigate the impact of water consumption and hydration on executive function capabilities, which may influence intervention adherence. Although increasing water intake could be an effective weight management strategy, no evidence-based recommendations exist for the timing of water intake needed for this benefit.

Вмешательства

  • Поведенческое Water intake and weight control in older adults - Premeal Water + hypocaloric diet
    Individuals will be randomly assigned to one of three groups. All individuals will receive counseling in a structured hypocaloric meal plan (1200-1500 kcal) that is consistent with a healthy dietary pattern as described by the Dietary Guidelines for Americans. This group will receive specific instructions for daily water intake timing and volume.
  • Поведенческое Water intake and weight control in older adults - Total Daily Water + hypocaloric diet
    Individuals will be randomly assigned to one of three groups. All individuals will receive counseling in a structured hypocaloric meal plan (1200-1500 kcal) that is consistent with a healthy dietary pattern as described by the Dietary Guidelines for Americans. This group will receive specific instructions for total daily water intake.
  • Поведенческое Water Intake and weight control in older adults - hypocaloric diet alone
    Individuals will be randomly assigned to one of three groups. All individuals will receive counseling in a structured hypocaloric meal plan (1200-1500 kcal) that is consistent with a healthy dietary pattern as described by the Dietary Guidelines for Americans. This group will receive instructions in the hypocaloric diet, without specific fluid intake recommendations.

Первичные конечные точки

  • Body weight change [Срок оценки: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase]
Вторичные конечные точки (3)
  • Change in appetite sensations [Срок оценки: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase]
  • Change in hydration status [Срок оценки: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase]
  • Change in executive function (EF) [Срок оценки: weeks 0 to 12 in the weight loss phase, month 0 to 12 post weight loss phase]

Критерии участия

Критерии включения

  • aged 50+ years
  • BMI ≥25 kg/m2
  • weight stable (+/- 2 kg) in past 6 months
  • willing to provide consent and comply with study protocol

Критерии исключения

  • usual plain drinking water intake >1500 ml/d
  • uncontrolled hypertension (>159/99 mmHg)
  • medical condition requiring specialized diet prescription (eg, T2D, CHF wih fluid restriction)
  • medical condition that precludes participating in a physical activity program (eg, orthopedic injury)
  • current or history of GI disease (eg, Crohn's), GI surgery, or medications which impact GI function
  • allergies or aversions to foods included in the test meals

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Virginia Tech — Blacksburg

Идентификаторы

NCT: NCT05843318 · 22-624

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗