NCT03114696已完成不适用
Double-blind, Placebo-controlled, Randomised Pilot Clinical Trial to Explore Benefit and Tolerability of IQP-AO-101 in Healthy Subjects With Sleep Complaints
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
- 50
- 试验地点
- 1
- 主要终点
- Change in mAIS parameters at V5 vs V2
研究概览
简要总结
The objective of this pilot clinical trial is to evaluate the potential of IQP-AO-101 with respect to sleep-promoting effects in subjects with sleep complaints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-65 years old
- •Non-organic moderate sleep complaints in the last year prior to V1, as per investigator's judgement
- •Pittsburgh Sleep Quality Index (PSQI) score 6-15 at V1
- •Body mass index (BMI) 18.5-29.9 kg/m2
- •Generally in good health without clinically significant findings at V1
- •Readiness to comply with study procedures, in particular:
- •Consumption of the IP during the treatment period
- •Wearing activity tracker during the scheduled time periods
- •Filling in the subject diary
- •Keeping habitual diet and level of physical exercise, as well as smoking habits if applicable
- •Women of child-bearing potential:
- •Negative pregnancy testing (ß-HCG in urine) at V1
- •Commitment to use reliable contraception methods during the entire study
- •Written informed consent form
排除标准
- •Known sensitivity to any components of the investigational product
- •Insomnia (according to investigator's judgement))
- •Substantial daily sleepiness as per investigator's judgement
- •Less than 5 hours sleep per night on average, self-reported at V1
- •Any medical condition associated with sleep disorder as per investigator's judgement (e.g. sleep apnoea, restless legs syndrome, neurological / psychiatric disorder)
- •Any lifestyle and other factors potentially associated with sleep problems as per investigator's judgement (e.g. excessive caffeine intake, shift work, long-distance travelling, significant stressors such as active grieving etc.)
- •History and/or presence of clinically significant dis-ease, which per investigator's judgement could interfere with the results of the study or the safety of the subject:
- •Eating disorders such as anorexia
- •Untreated or non-stabilised metabolic diseases, e.g. diabetes mellitus
- •Untreated or non-stabilised thyroid disorder
- •Untreated or non-stabilised hypertension (regular systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg)
- •Significant gastrointestinal diseases
- •Any other known significant or serious condition / disease that renders subjects ineligible (e.g. history of malignancy within the past 5 years prior to V1, any clinically significant cardiovascular, renal, liver disease etc.)
- •Use of drugs/supplements which could interfere with the results of the study as per investigator's judgement (e.g. melatonin and melatonin derivatives, stimulants, neuroleptics, benzodiazepines, antidepressants, hypnotics) within the last 4 weeks prior to V1 and during the study
- •Behavioural intervention for sleep difficulties in the past 6 months and during the study as per investigator's judgement
- •Deviation of laboratory parameter(s) at V1 that is:
- •clinically significant or
- •>2x ULN (upper limit of normal), unless the deviation is justified by a previously known not clinically relevant condition, e.g. Gilbert's syndrome)
- •Alcohol abuse (men: ≥21 units/week, women: ≥14 units/ week; 1 unit equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
- •Participation in another study during the last 4 weeks prior to V1 and during the study
- •Women of child-bearing potential: pregnant or breast-feeding
- •Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
研究组 & 干预措施
IQP-AO-101
Experimental
1 dose (sachet) to be consumed 30 - 60 mins before bedtime
干预措施: IQP-AO-101 (Dietary Supplement)
Placebo
Placebo Comparator
1 dose (sachet) to be consumed 30 - 60 mins before bedtime
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in mAIS parameters at V5 vs V2
时间窗: 6 weeks
Change in modified Athens Insomnia Scale parameters
次要结局
- Change in mAIS parameter at V3 and V4, vs V2(1 week, 4 weeks)
- Change in activity tracker sleep parameters(1 week, 6 weeks)
- Change in FAIR-2(1 week, 4 weeks, 6 weeks)
研究者
研究点 (1)
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