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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2017
CompletedFirst Posted
Study publicly available on registry
April 14, 2017
CompletedStudy Start
First participant enrolled
April 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2017
CompletedJanuary 3, 2018
January 1, 2018
5 months
April 6, 2017
January 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in mAIS parameters at V5 vs V2
Change in modified Athens Insomnia Scale parameters
6 weeks
Secondary Outcomes (3)
Change in mAIS parameter at V3 and V4, vs V2
1 week, 4 weeks
Change in activity tracker sleep parameters
1 week, 6 weeks
Change in FAIR-2
1 week, 4 weeks, 6 weeks
Other Outcomes (2)
Safety parameters assessed by number of subjects with abnormal laboratory values
1 week, 4 weeks, 6 weeks
Adverse events that are related to treatment
6 weeks
Study Arms (2)
IQP-AO-101
EXPERIMENTAL1 dose (sachet) to be consumed 30 - 60 mins before bedtime
Placebo
PLACEBO COMPARATOR1 dose (sachet) to be consumed 30 - 60 mins before bedtime
Interventions
1 dose to be consumed 30 - 60 mins before bedtime. (Identical to investigational product)
Eligibility Criteria
You may qualify if:
- years old
- Non-organic moderate sleep complaints in the last year prior to V1, as per investigator's judgement
- Pittsburgh Sleep Quality Index (PSQI) score 6-15 at V1
- Body mass index (BMI) 18.5-29.9 kg/m2
- Generally in good health without clinically significant findings at V1
- 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
- Women of child-bearing potential:
- Negative pregnancy testing (ß-HCG in urine) at V1
- Commitment to use reliable contraception methods during the entire study
- Written informed consent form
You may not qualify if:
- Known sensitivity to any components of the investigational product
- Insomnia (according to investigator's judgement))
- Substantial daily sleepiness as per investigator's judgement
- Less than 5 hours sleep per night on average, self-reported at V1
- Any medical condition associated with sleep disorder as per investigator's judgement (e.g. sleep apnoea, restless legs syndrome, neurological / psychiatric disorder)
- 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.)
- 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.)
- 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
- Behavioural intervention for sleep difficulties in the past 6 months and during the study as per investigator's judgement
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InQpharm Grouplead
- Analyze & Realizecollaborator
Study Sites (1)
Analyze & Realize
Berlin, 10369, Germany
Related Publications (1)
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.
PMID: 31186669DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2017
First Posted
April 14, 2017
Study Start
April 25, 2017
Primary Completion
September 29, 2017
Study Completion
September 29, 2017
Last Updated
January 3, 2018
Record last verified: 2018-01