Benefit of IQP-AO-101 for Sleep

InQpharm

Status: Completed

Conditions: Insomnia, Nonorganic

Treatments: Dietary Supplement: Placebo; Dietary Supplement: IQP-AO-101

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT03114696

INQ/020316

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

IQP-AO-101

Experimental group

Description:

1 dose (sachet) to be consumed 30 - 60 mins before bedtime

Treatment:

Dietary Supplement: IQP-AO-101

Placebo

Placebo Comparator group

Description:

1 dose (sachet) to be consumed 30 - 60 mins before bedtime

Treatment:

Dietary Supplement: Placebo