Benefit of IQP-AO-101 for Sleep

Study Overview
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Brief Summary
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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.

Official Title
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Double-blind, Placebo-controlled, Randomised Pilot Clinical Trial to Explore Benefit and Tolerability of IQP-AO-101 in Healthy Subjects With Sleep Complaints

Conditions
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Insomnia, Nonorganic

Intervention / Treatment
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* Dietary Supplement: IQP-AO-101
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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 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: 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) 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IQP-AO-101<br>1 dose (sachet) to be consumed 30 - 60 mins before bedtime | Dietary Supplement: IQP-AO-101<br>* 1 dose (sachet) to be consumed 30 - 60 mins before bedtime<br>|
| Placebo Comparator: Placebo<br>1 dose (sachet) to be consumed 30 - 60 mins before bedtime | Dietary Supplement: Placebo<br>* 1 dose to be consumed 30 - 60 mins before bedtime. (Identical to investigational product)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mAIS parameters at V5 vs V2 | Change in modified Athens Insomnia Scale parameters | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 1 week, 6 weeks | 
| Change in FAIR-2 | Change in FAIR-2 at each visit | 1 week, 4 weeks, 6 weeks |