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| Name | Class |
|---|---|
| Analyze & Realize | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IQP-AO-101 | Experimental | 1 dose (sachet) to be consumed 30 - 60 mins before bedtime |
|
| Placebo | Placebo Comparator | 1 dose (sachet) to be consumed 30 - 60 mins before bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IQP-AO-101 | Dietary Supplement | 1 dose (sachet) to be consumed 30 - 60 mins before bedtime |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mAIS parameters at V5 vs V2 | Change in modified Athens Insomnia Scale parameters | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mAIS parameter at V3 and V4, vs V2 | Change in modified Athens Insomnia Scale parameters | 1 week, 4 weeks |
| Change in activity tracker sleep parameters | Use of an activity tracker to monitor sleep and compare against baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters assessed by number of subjects with abnormal laboratory values | Number of subjects with abnormal laboratory values | 1 week, 4 weeks, 6 weeks |
| Adverse events that are related to treatment |
Inclusion Criteria:
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:
Women of child-bearing potential:
Written informed consent form
Exclusion Criteria:
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:
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:
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)
Drug abuse
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Analyze & Realize | Berlin | 10369 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31186669 | Derived | Bongartz U, Tan BK, Seibt S, Bothe G, Uebelhack R, Chong PW, Wszelaki N. Sleep Promoting Effects of IQP-AO-101: A Double-Blind, Randomized, Placebo-Controlled Exploratory Trial. Evid Based Complement Alternat Med. 2019 May 2;2019:9178218. doi: 10.1155/2019/9178218. eCollection 2019. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Placebo |
| Dietary Supplement |
1 dose to be consumed 30 - 60 mins before bedtime. (Identical to investigational product) |
|
| 1 week, 6 weeks |
| Change in FAIR-2 | Change in FAIR-2 at each visit | 1 week, 4 weeks, 6 weeks |
Monitoring of adverse effects
| 6 weeks |
| D001523 |
| Mental Disorders |