NCT02763514已完成不适用
Efficacy Evaluation of 26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Cognitive Function and Mood 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
- 337
- 试验地点
- 1
- 主要终点
- Episodic memory
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 cognitive function (episodic memory, attention, working memory, executive function), subjective mood, alertness and mental fatigue after 26 weeks daily 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
排除标准
- •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 omega-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
研究组 & 干预措施
DHA-enriched oil
Active Comparator
3 g PronovaPure 150:500 EE EU
干预措施: 3 g PronovaPure 150:500 EE EU (Dietary Supplement)
EPA-enriched oil
Active Comparator
3 g PronovaPure 500:200 EE EU
干预措施: 3 g PronovaPure 500:200 EE EU (Dietary Supplement)
Placebo
Placebo Comparator
3 g Olive oil
干预措施: 3 g Placebo (Dietary Supplement)
结局指标
主要结局
Episodic memory
时间窗: 26 weeks
An overall score for Episodic memory will be derived by calculating the average score from 6 separate standardised task outcomes (Zimmediate word recall accuracy + Zdelayed word recall accuracy + Zword recognition accuracy + Zpicture recognition accuracy - Zimmediate word recall errors - Zdelayed word recall errors)/6
Subjective fatigue
时间窗: 26 weeks
Subjective fatigue will be derived from the Fatigue subscale of the Profile of Mood States questionnaire
次要结局
- Numeric Working memory(26 weeks)
- Stroop task(26 weeks)
- Rapid visual information processing(26 weeks)
- Subjective alertness(26 weeks)
- Subjective mental fatigue(26 weeks)
- Simple reaction time(26 weeks)
- Subjective confusion(26 weeks)
- Subjective overall mood disturbance(26 weeks)
- Verbal fluency(26 weeks)
- Subjective vigour(26 weeks)
- Subjective anger(26 weeks)
- Subjective tension(26 weeks)
研究者
Philippa Jackson
Dr
Northumbria University
研究点 (1)
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