Effects of an Evening PROtein PrEload on Metabolic Health in Night ShIfT Workers (PROPENSITy)
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: whey protein, Placebo.
- Кому может быть актуально
- Состояния в реестре: Type 2 Diabetes, Shift-work Disorder. Базовые параметры: 35 лет — 65 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
- Австралия
- 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
Effects of an Evening PROtein PrEload on Blood Glucose, Metabolic Health, and Gut Hormone Release in Night ShIfT Workers (PROPENSITy)
Обзор
This study will compare the effects of a whey protein supplement or a placebo consumed before the evening meal on health outcomes in night shift workers.
Подробное описание
Participants are assigned in random order to two conditions, for 12 days each. The interventions are 1) a 30g whey protein preload consumed 1-1.5 hr prior to their main evening meal every day for 12 days. No other advice will be given. 2) an identical mixed-nutrient drink matched for caloric content, taste and palatability consumed 1-1.5 hr prior to their main evening meal every day for 12 days(placebo). Conditions are separated by a 2-week washout period, during which participants will be encouraged to maintain their habitual diet and physical activity levels. Metabolic testing will be performed at baseline, and at the end of both conditions.
Вмешательства
- Пищевая добавка whey protein
Protein drink containing 30g whey protein isolate powder (dissolved in water) consumed 1-1.5 hr prior to their main evening meal every day for 12 days, No other advice will be given. - Пищевая добавка Placebo
Energy-matched mixed-nutrient placebo drink consumed 1-1.5 hr prior to their main evening meal every day for 12 days. No other advice will be given.
Первичные конечные точки
- Glycaemic response [Срок оценки: 12 days (3 hours meal test)]
Вторичные конечные точки (12)
- 24-hour glucose profiles [Срок оценки: 12 days]
- Glucose variability [Срок оценки: 12 days]
- Glucose variability [Срок оценки: 12 days]
- Glucose variability [Срок оценки: 12 days]
- GLP-1 [Срок оценки: 12 days (3 hours meal test)]
- GIP [Срок оценки: 12 days (3 hours meal test)]
- glucagon [Срок оценки: 12 days (3 hours meal test)]
- Insulin [Срок оценки: 12 days]
- Ghrelin [Срок оценки: 12 days (3 hours meal test)]
- PYY [Срок оценки: 12 days]
- Adiponectin [Срок оценки: 12 days]
- C-Reactive Protein (CRP) [Срок оценки: 12 days]
Критерии участия
Критерии включения
- Female
- Night shift workers (with a minimum of 6 months in their current shift work schedule)
- 35-65 years
- BMI 28.0-35.0 kg/m2; waist circumference > 80cm
- Weight stable in the past 6 months
Критерии исключения
- Those working standard day time hours only, or those who work less than three to four night shifts per fortnight on average
- Personal history and/or diagnosis of: diabetes, cancer, major psychiatric disorders, liver disease, gastro-intestinal surgery or disease (including malabsorption), eating disorders, anaemia, insomnia or cardiovascular disease, and/or any other condition deemed unstable by the study physician
- Taking medications known to alter body composition or metabolism, including (but not limited to): any medication used to lower blood glucose or antidiabetic medications (metformin, sulfonylureas, Glucagon-like peptide-1 (GLP-1) analogues \[i.e. exenatide\], thiazolidinediones or DPP-IV inhibitors \[i.e. 'gliptins'\]), medications affecting weight, appetite or gut motility (i.e. diuretics, domperidone, cisapride, orlistat, phentermine, topiramate)
- Participants who are taking stable doses (i.e. > 12 months) of androgenic medications (i.e. testosterone) or SSRI's will not be excluded. Personal history/diagnosis (self-reported) of diabetes (type 1 or 2), major psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, eating disorders), gastrointestinal disorders, haematological disorders (i.e. thalassemia, iron-deficiency anaemia) insomnia, or any other medical condition, deemed unstable by the study physician
- Pregnant, planning a pregnancy or breastfeeding
- Those who have lost or gained >5% of body weight in the last 6 months
- Those who consume four or more standard drinks on a single occasion at a 'daily or almost daily' occurrence
- current smokers of cigarettes/marijuana/e-cigarettes/vaporisers
- unable to comprehend the study protocol (i.e. due to English language or cognitive difficulties)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Двойное слепое
- Основная цель
- Профилактика
Центры проведения
Австралия · 1 центр
- University of Adelaide — Adelaide
Идентификаторы
NCT: NCT04869098 · H-2020-131