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Benefit of IQP-AO-101 for Sleep

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114696
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
Analyze & Realize
Information provided by (Responsible Party):
InQpharm Group

Brief 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.

Condition or disease Intervention/treatment Phase
Insomnia, Nonorganic Dietary Supplement: IQP-AO-101 Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Placebo-controlled, Randomised Pilot Clinical Trial to Explore Benefit and Tolerability of IQP-AO-101 in Healthy Subjects With Sleep Complaints
Actual Study Start Date : April 25, 2017
Actual Primary Completion Date : September 29, 2017
Actual Study Completion Date : September 29, 2017

Arm Intervention/treatment
Experimental: IQP-AO-101
1 dose (sachet) to be consumed 30 - 60 mins before bedtime
Dietary Supplement: IQP-AO-101
1 dose (sachet) to be consumed 30 - 60 mins before bedtime

Placebo Comparator: Placebo
1 dose (sachet) to be consumed 30 - 60 mins before bedtime
Dietary Supplement: Placebo
1 dose to be consumed 30 - 60 mins before bedtime. (Identical to investigational product)




Primary Outcome Measures :
  1. Change in mAIS parameters at V5 vs V2 [ Time Frame: 6 weeks ]
    Change in modified Athens Insomnia Scale parameters


Secondary Outcome Measures :
  1. Change in mAIS parameter at V3 and V4, vs V2 [ Time Frame: 1 week, 4 weeks ]
    Change in modified Athens Insomnia Scale parameters

  2. Change in activity tracker sleep parameters [ Time Frame: 1 week, 6 weeks ]
    Use of an activity tracker to monitor sleep and compare against baseline

  3. Change in FAIR-2 [ Time Frame: 1 week, 4 weeks, 6 weeks ]
    Change in FAIR-2 at each visit


Other Outcome Measures:
  1. Safety parameters assessed by number of subjects with abnormal laboratory values [ Time Frame: 1 week, 4 weeks, 6 weeks ]
    Number of subjects with abnormal laboratory values

  2. Adverse events that are related to treatment [ Time Frame: 6 weeks ]
    Monitoring of adverse effects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114696


Locations
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Germany
Analyze & Realize
Berlin, Germany, 10369
Sponsors and Collaborators
InQpharm Group
Analyze & Realize
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT03114696    
Other Study ID Numbers: INQ/020316
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders