- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02873910
Influence of IQPAS-119 on Post-Marathon Susceptibility to Infections and Others
January 1, 2018 updated by: InQpharm Group
Randomized, Double-Blind, Placebo-Controlled, Monocentric, Parallel-Group Study to Evaluate the Influence of IQPAS-119 on Post-Marathon Susceptibility to Infections and Influence on Other Complaints and Its Tolerability: A Pilot Study
The purpose of this study is to evaluate the benefit and tolerability of IQP-AS-119 for reduction of susceptibility to infections and other complaints after extreme physical stress (participation in a marathon).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany, 10369
- analyze & realize GmbH
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Caucasian males and females, 18-65 years of age, residents of Berlin or Brandenburg
- Body mass index (BMI) 18.5-26.0 kg/m2
- Registered as runner for the 43rd BMW Berlin Marathon 2016
- History of at least 2 successful finished marathons (personal record of 3-5.5h within the last 5 years)
- History of post-exercise susceptibility to infections (e.g. upper respiratory tract symptoms) and/or other health conditions (infections, stress complaints) after strenuous exercise (eg. marathon, half-marathon, bicycle races, triathlons, heavy training loads) within the last 5 years (to be distinctly documented at screening)
Readiness to comply with all study procedures, in particular:
- Consumption of the investigational product (IP) during the entire treatment period of the study
- Maintaining the habitual diet, with the exception of consumption of maximal 2 garlic cloves per week
- Adapt pre-marathon training / physical activity to generally accepted proven or individually successful training plan
- Adapt post-marathon training / physical activity to generally accepted proven or individually successful recovery plan
- Filling in diaries and questionnaires
- Readiness to ensure generally proven or individually successful optimal food intake and rehydration before, during, and after the marathon.
- Non-smoker / smoking cessation of last ≥12 months prior to screening
- Regular sleeping pattern (no suspicion of sleep disorder) in the three months prior to screening
- Stable concomitant, permitted medication (if any) for at least last 2 weeks prior to screening and during the study
Women of child-bearing potential only:
- negative pregnancy testing (Beta human chorionic gonadotropin (ß-HCG) in urine) at screening
- commitment to use reliable contraception methods during the entire study
Participation is based upon written informed consent form (ICF) by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
Exclusion Criteria:
- Known sensitivity to any ingredients of the IP
- Additional strenuous exercise/activity other than regular occupational load, completing training runs / exercises prior the marathon. Additional strenuous exercise/activity other than regular occupational load and recovery exercise loads after the marathon
- History of severe cardiovascular disease or collapse during a running event (half marathon, marathon etc.) and/or training
- Hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg)
- Any abnormality observed in screening exercise ECG pointing to an increased cardiovascular risk (alternatively: any abnormality in the results of an exercise ECG performed in the last 6 weeks prior to screening pointing to an increased cardiovascular risk)
- Any chronic disease affecting the upper respiratory tract and the lungs, eg. asthma bronchial, chronic obstructive pulmonary disease, or ears-nose-throat (ENT) infection
- Acute infection of ENT or upper respiratory tract (URT) within the last month prior to screening
Any nasal abnormalities:
- History of nasal reconstructive surgery
- Severe nasal septum deviation or other condition that could cause nasal obstruction
- Presence of nasal ulcers or nasal polyps
- Active organ or systemic diseases including severe cardiovascular disease, diabetes mellitus, renal or liver disorder
- Known congenital or acquired immunodeficiency disease (e.g. HIV infection)
- Known bleeding disorders such as bleeding ulcers, or haemophilia
- Vaccination against influenza within 3 months prior to screening; any vaccination planned during the study
- Anticoagulants such as warfarin
- Systemic analgesics (other than paracetamol up to 2000mg/day or ibuprofen up to max. 800 mg/day, or if medically indicated and prescribed by a physician), antibiotics (unless medically indicated and prescribed by a physician) or decongestant nose drops / spray (except for isotonic sea water, or if medically indicated and prescribed by a physician) during the study
- Use of medications or supplements influencing immune function (e.g. antihistamines, systemic corticosteroids, immune-suppressants), and physical performance, as per investigator's judgement, during the study
- Use of any doping substance as listed by the "World Anti-Doping Agency" at present or in the past, unless prescribed by a physician under a '"therapeutic use exemption", per investigator's judgement
- Any use of food supplements containing vitamins, minerals, or trace elements, as per investigator's judgement, during the study
- 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)
- Women of child-bearing potential: pregnant or breastfeeding
- Participation in other studies within the last month prior to screening and during study
- Any other clinically significant condition which in the investigator's opinion could interfere with the results of the study or the safety of the subject
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IQP-AS-119
One tablet to be taken daily with any meal, with a glass of water.
They should not be chewed, but swallowed whole.
|
|
Placebo Comparator: Placebo
One tablet to be taken daily with any meal, with a glass of water.
They should not be chewed, but swallowed whole.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hooper's Index
Time Frame: 5 weeks
|
Compared between verum and placebo groups at baseline and all timepoints thereafter.
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Questionnaire (PSQ20)
Time Frame: 5 weeks
|
Compared between verum and placebo groups at baseline and all timepoints thereafter.
|
5 weeks
|
URT symptoms recorded in daily dairy
Time Frame: 5 weeks
|
Compared between verum and placebo groups at baseline and all timepoints thereafter.
|
5 weeks
|
Daily subject diary on URT symptoms and other health conditions (including Overall Treatment Effect (OTE)
Time Frame: 5 weeks
|
Compared between verum and placebo groups at baseline and all timepoints thereafter.
|
5 weeks
|
Wisconsin upper respiratory symptom survey (WURSS-21)
Time Frame: 5 weeks
|
Compared between verum and placebo groups at baseline and all timepoints thereafter.
|
5 weeks
|
Short Form-12 (SF-12) Health Survey
Time Frame: 5 weeks
|
Compared between verum and placebo groups at baseline and all timepoints thereafter.
|
5 weeks
|
Global evaluation of benefit (4-point categorical scale)
Time Frame: 5 weeks
|
Measured by the subjects/investigator at the final visit only
|
5 weeks
|
Blood pressure
Time Frame: 5 weeks
|
Compared between verum and placebo groups at baseline and all timepoints thereafter.
|
5 weeks
|
Pulse rate
Time Frame: 5 weeks
|
Compared between verum and placebo groups at baseline and all timepoints thereafter.
|
5 weeks
|
Body temperature
Time Frame: 5 weeks
|
Compared between verum and placebo groups at baseline and all timepoints thereafter.
|
5 weeks
|
Adverse events (AEs) throughout study
Time Frame: 5 weeks
|
Compared between verum and placebo groups at baseline and all timepoints thereafter.
|
5 weeks
|
Global evaluation of tolerability (4-point categorical scale)
Time Frame: 5 weeks
|
Measured by the subjects/investigator
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ralf Uebelhack, MD, phD, analyze & realize GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 10, 2016
Primary Completion (Actual)
October 31, 2016
Study Completion (Actual)
October 31, 2016
Study Registration Dates
First Submitted
August 8, 2016
First Submitted That Met QC Criteria
August 16, 2016
First Posted (Estimate)
August 22, 2016
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
Other Study ID Numbers
- INQ/009716
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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