NCT03559361已完成不适用
Efficacy Evaluation of 26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Sleep Efficiency in Healthy Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Objective sleep efficiency
研究概览
简要总结
The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on a number of objective sleep measures (collected from Activity watches) and subjective sleep measures (collected from the Leeds Sleep Evaluation Questionnaire) before and after 26 weeks of supplementation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 25 to 49 years inclusive
- •Males and females
- •Self-report of good health
- •Sleeping pattern must include at least four consecutive nights per week that are the same
- •Exclusion Criteria
- •English is not first language (some of the cognitive tasks have only been validated in native English speakers)
- •Habitual consumption of oily fish exceeds one fish meal per week
- •Habitual consumption of n-3 dietary supplements in the previous 6 months
- •Habitual use of dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total; some supplements that do not impact upon cognitive function e.g. garlic, protein, calcium are allowed. Please check with the research team if you are unsure)
- •Are a smoker or consume any nicotine replacement products (e.g. chewing gum, e-cigarettes)?
- •Food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
- •Pregnant, trying to get pregnant or breast feeding
- •Body Mass Index outside of the range 18-35 kg/m2
- •High blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
- •Currently taking blood pressure medication
- •Currently taking blood thinning medication (e.g. aspirin, warfarin, heparin)
- •Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
- •Have frequent migraines that require medication (more than or equal to 1 per month)
- •History or current diagnosis of drug/alcohol abuse
- •History of kidney or liver disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalcaemia), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
- •History of neurological or psychiatric illness (excluding depressive illness and anxiety)
- •History of head trauma
- •Sleep disturbances and/or are taking sleep aid medication
- •Blood disorders (e.g. anaemia, haemophilia, thrombocytosis)
- •Diagnosis of type I or type II diabetes
- •Heart disorder, or vascular illness
- •Current diagnosis of depression and/or anxiety
- •Over- or under-active thyroid
- •Chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, celiac disease)
- •Any known active infections
- •Diagnosed with or may be at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus
- •Current or past breast cancer diagnosis and/or a mastectomy
- •Health condition that would prevent fulfilment of the study requirements
- •Currently participating in or in the past 4 weeks participated in other clinical or nutrition intervention studies
排除标准
- 未提供
研究组 & 干预措施
Olive oil Placebo
Placebo Comparator
3 x 1 g capsules daily Placebo: olive oil
干预措施: Olive oil Placebo (Dietary Supplement)
EPA-rich
Active Comparator
3 x 1 g capsules daily containing a SMEDDS formulation of an EPA-enriched oil totalling 900 mg EPA and 360 mg of DHA
干预措施: EPA-rich (Dietary Supplement)
DHA-Rich
Active Comparator
3 x 1 g capsules daily containing a SMEDDS formulation of an DHA-enriched oil totalling 900 mg DHA and 270 mg of EPA
干预措施: DHA-rich (Dietary Supplement)
结局指标
主要结局
Objective sleep efficiency
时间窗: 26 weeks
Sleep efficiency scores collected from research sleep watches
次要结局
- Subjective Ratings of Sleep quality(26 weeks)
- Urinary melatonin(26 weeks)
研究者
Philippa Jackson
Prinicipal Investigator
Northumbria University
研究点 (2)
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