Benefit of IQP-AO-101 for Sleep

This is an interventional treatment trial for Insomnia, Nonorganic Read More

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