benefit of iqp-ao-101 for sleep

Conditions: Insomnia, Nonorganic

Summary: 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.


Eligibility criteria:
inclusion criteria: 1. 21-65 years old 2. non-organic moderate sleep complaints in the last year prior to v1, as per investigator's judgement 3. pittsburgh sleep quality index (psqi) score 6-15 at v1 4. body mass index (bmi) 18.5-29.9 kg/m2 5. generally in good health without clinically significant findings at v1 6. 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 7. women of child-bearing potential: * negative pregnancy testing (ß-hcg in urine) at v1 * commitment to use reliable contraception methods during the entire study 8. written informed consent form 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