Benefit of IQP-AO-101 for Sleep

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03114696
• Date of registration: 06/04/2017
• Prospective Registration: Yes
• Primary sponsor: InQpharm Group
• Public title: Benefit of IQP-AO-101 for Sleep
• Scientific title: Double-blind, Placebo-controlled, Randomised Pilot Clinical Trial to Explore Benefit and Tolerability of IQP-AO-101 in Healthy Subjects With Sleep Complaints
• Date of first enrolment: April 25, 2017
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03114696
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Germany

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Insomnia, Nonorganic

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: IQP-AO-101

Primary Outcome(s)

Change in mAIS parameters at V5 vs V2 [Time Frame: 6 weeks]

Secondary Outcome(s)

Change in activity tracker sleep parameters [Time Frame: 1 week, 6 weeks]

Change in mAIS parameter at V3 and V4, vs V2 [Time Frame: 1 week, 4 weeks]

Change in FAIR-2 [Time Frame: 1 week, 4 weeks, 6 weeks]

Secondary ID(s)

INQ/020316

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Analyze & Realize