ACTRN12620000411943撤回未知
Determining the effect of freeze-dried green kiwifruit powder on sleep quality and underlying mechanisms in healthy males with sub-threshold insomnia: a randomised controlled, double-blind, crossover study
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •Healthy males
- •Aged between 18-45 years of age
- •Body mass index (BMI) (18.5-30kg/m2)
- •Physically active but no more than 2 hours per day
- •Poor sleepers, defined as having an ISI (Insomnia Severity Index) score of >8 (Ree, Pollitt, & Harvey, 2006) and the Pittsburgh Sleep Quality Index (PSQI) score >5 (Buysse, Reynolds III, Monk, Berman, & Kupfer, 1988)
- •Glycated haemoglobin (HbA1c) test, value <41mmol/mol (greater than this is considered prediabetes) (Braatvedt et al., 2012)
排除标准
- •Use of specific prescribed medication as listed below or recreational drugs use:
- •Diuretics, Oral or inhaled steroids, Cholinergic antispasmodics, Lactulose, Metamucil, Antibiotics, Sedative/hypnotic medication, Laxatives, Antacids, Cholesterol-lowering medications, Proton pump inhibitors (acid reflux treatments), Vitamin/mineral supplements, Heparin, Antidepressants
- •Excessive alcohol intake defined as >20g of pure alcohol (2 drinks)/d on average. (>21 standard drinks a week)
- •Smoke cigarettes
- •History of gastrointestinal surgery or gastrointestinal disorders including inflammatory bowel disease (IBD), ulcerative colitis, coeliac disease, Crohn’s disease
- •Medical conditions (e.g., cardiorespiratory, diabetes mellitus, bleeding disorders)
- •Psychiatric conditions (e.g., Major depressive disorder, Schizophrenia)
- •Antibiotic consumption (1 month before the study and during the study)
- •Significant weight loss during the past six months
- •Being on a controlled diet or dietary weight loss regimen within four weeks before and during the study
- •Vegetarian/vegan
- •Aversion to blood sampling
- •Allergies to dairy products or eggs or fruits
- •Participants will be asked to abstain from alcohol before attending a sleep session at the laboratory and to abstain from caffeinated beverages and vigorous exercise eight hours before their averaged bedtimes
- •Diagnosed with or symptoms of COVID-19
研究者
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