Effects of an Evening PROtein PrEload on Blood Glucose, Metabolic Health, and Gut Hormone Release in Night ShIfT Workers (PROPENSITy)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Glycaemic response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Glycaemic response
时间窗: 12 days (3 hours meal test)
Change in glucose (AUC) following a standard breakfast
次要结局
- GIP(12 days (3 hours meal test))
- PYY(12 days)
- Adiponectin(12 days)
- Resting metabolic rate(12 days)
- 24-hour glucose profiles(12 days)
- GLP-1(12 days (3 hours meal test))
- glucagon(12 days (3 hours meal test))
- Insulin(12 days)
- C-Reactive Protein (CRP)(12 days)
- Blood pressure(12 days)
- respiratory quotient(12 days)
- Blood lipids(12 days)
- Ghrelin(12 days (3 hours meal test))
- Glucose variability(12 days)
研究者
A/Prof Leonie Heilbronn
A/Prof
University of Adelaide