Benefit of IQP-AO-101 for Sleep

Exclusion Criteria

• •1. Known sensitivity to any components of the investigational product
• •2. Insomnia (according to investigator's judgement))
• •3. Substantial daily sleepiness as per investigator's judgement
• •4. Less than 5 hours sleep per night on average, self-reported at V1
• •5. Any medical condition associated with sleep disorder as per investigator's judgement (e.g. sleep apnoea, restless legs syndrome, neurological / psychiatric disorder)
• •6. 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.)
• •7. 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.)
• •8. 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
• •9. Behavioural intervention for sleep difficulties in the past 6 months and during the study as per investigator's judgement
• •10. 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)
• •11. 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)
• •12. Drug abuse
• •13. Participation in another study during the last 4 weeks prior to V1 and during the study
• •14. Women of child-bearing potential: pregnant or breast-feeding
• •15. Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures