Benefit of IQP-AO-101 for Sleep

Double-blind, Placebo-controlled, Randomised Pilot Clinical Trial to Explore Benefit and Tolerability of IQP-AO-101 in Healthy Subjects With Sleep Complaints

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.

Study Overview

• Status: Completed
• Conditions: Insomnia, Nonorganic
• Intervention / Treatment: Dietary supplement: IQP-AO-101; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10369
    • Analyze & Realize

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mAIS parameters at V5 vs V2	Change in modified Athens Insomnia Scale parameters	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mAIS parameter at V3 and V4, vs V2	Change in modified Athens Insomnia Scale parameters	1 week, 4 weeks
Change in activity tracker sleep parameters	Use of an activity tracker to monitor sleep and compare against baseline	1 week, 6 weeks
Change in FAIR-2	Change in FAIR-2 at each visit	1 week, 4 weeks, 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety parameters assessed by number of subjects with abnormal laboratory values	Number of subjects with abnormal laboratory values	1 week, 4 weeks, 6 weeks
Adverse events that are related to treatment	Monitoring of adverse effects	6 weeks

Collaborators and Investigators

• Sponsor: InQpharm Group
• Collaborators: Analyze & Realize

Publications and helpful links

General Publications

• Bongartz U, Tan BK, Seibt S, Bothe G, Uebelhack R, Chong PW, Wszelaki N. Sleep Promoting Effects of IQP-AO-101: A Double-Blind, Randomized, Placebo-Controlled Exploratory Trial. Evid Based Complement Alternat Med. 2019 May 2;2019:9178218. doi: 10.1155/2019/9178218. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2017
• Primary Completion (Actual): September 29, 2017
• Study Completion (Actual): September 29, 2017

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 1, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: INQ/020316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No