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Идёт набор NCT07480109

Increased Dietary Protein Intake During GLP-1 Medication Use (in Middle-aged Women With Overweight/Obesity)

Без фазы С лечением Obesity Women (Between 30 to 60 Years Old)

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: Protein Rich Foods.
Кому может быть актуально
Состояния в реестре: Obesity, Women (Between 30 to 60 Years Old). Базовые параметры: 30 лет — 60 лет · Женщины.
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
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Официальное название

The 'Power of Pork Protein' (From Diverse Pork Products) to Promote Health and Well-being During GLP-1 Medication Use in Middle-aged Women (With Overweight/Obesity)

Обзор

Middle-aged women with (overweight/)obesity who will begin or have begun GLP-1 medication use will be recruited to complete a 12-week diet intervention study. For 12-weeks, participants will continue to take their GLP-1 medication and may be provided with protein-rich foods to consume every day. Body composition, eating behavior, health, and well-being will be measured before and after the study.

Подробное описание

Middle-aged women with (overweight/)obesity who will begin or have begun GLP-1 medication use will be recruited to complete a 12-week, parallel-design, dietary protein intervention trial. The participants will be randomized into the following groups: GLP-1 ONLY (no dietary intervention) or GLP-1 + Protein. The GLP-1 only group will take/continue to take the respective GLP-1 medication as prescribed by their physician, whereas the GLP-1 + Protein group will take/continue to take the respective GLP-1 medication as prescribed by their physician but will be provided with a variety of protein-rich pork foods to yield 20 g of protein, twice daily, for 12 weeks, totaling \~40 g high quality protein. In addition, recipes will be provided to support the consumption of the protein-rich foods within the breakfast meal (required) and in other eating occasions. Baseline and post-study assessments include body composition, eating behavior, food intake, appetite, satiety, food cravings, food reward, and health \& well-being.

Вмешательства

  • Поведенческое Protein Rich Foods
    For 12 weeks, the participants will either receive a variety of pork-based protein-rich foods, or will continue to eat their habitual diet without any dietary intervention.

Первичные конечные точки

  • Body Composition [Срок оценки: Baseline and 12 weeks]
  • Muscle Mass [Срок оценки: Baseline and 12 weeks]
  • 3-day Average Daily Intake [Срок оценки: Baseline and 12 weeks]
Вторичные конечные точки (8)
  • Energy Expenditure and Sleep [Срок оценки: Baseline and 12 weeks]
  • Food Noise [Срок оценки: Baseline, 2 week, 4 week, 6 week, 8 week, 10 week, 12 weeks]
  • Depression [Срок оценки: Baseline and 12 weeks]
  • Anxiety [Срок оценки: Baseline and 12 weeks]
  • Pork Consumption [Срок оценки: Baseline and 12 weeks]
  • Appetite, Satiety, Food Craving and Mood [Срок оценки: Baseline and 12 weeks]
  • Control of Eating [Срок оценки: Baseline and 12 weeks]
  • Health and Well-being Questionnaire [Срок оценки: Baseline and 12 weeks]

Критерии участия

Критерии включения

  • Adult women (30-60 years)
  • Having overweight or obesity (BMI >25 kg/m2)
  • Prescribed or taking GLP-1 medicine (within 4 weeks) by a physician
  • Willing and able to maintain current inactivity patterns throughout the study
  • Willing and able to follow all study procedures
  • Generally healthy, as assessed from the medical history questionnaire

Критерии исключения

  • Adults (<30 years or >60 years)
  • Having normal weight (BMI <25 kg/m2)
  • Not prescribed GLP-1 medication by a physician
  • Those on GLP-1 medication longer than 4 weeks (during time of screening)
  • Currently on a high-protein or other specific diet
  • Unwilling and/or unable to maintain current inactivity patterns throughout the study
  • Unwilling and/or unable to follow all study procedures
  • Unwilling and/or unable to eat pork (for the GLP-1 + Protein group)
  • Not generally healthy, as assessed from the medical history questionnaire

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Dell Pediatric Research Center — Austin
  • University of Texas at Austin — Austin

Идентификаторы

NCT: NCT07480109 · FP00012519

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗