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Upper Respiratory Tract SymptomsNCT02873910

Influence of IQPAS-119 on Post-Marathon Susceptibility to Infections and Others

A study testing IQP-AS-119 in people with Upper Respiratory Tract Symptoms, run by InQpharm Group at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Upper Respiratory Tract Symptoms
What is being tested?
IQP-AS-119
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteGermany
Study dates
10 Jul 2016to 31 Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • analyze & realize GmbH

    Berlin, 10369

Other trials in Germany

About this study

Official title: 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).

Being tested
IQP-AS-119, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IQP-AS-119Dietary supplement

  • PlaceboDietary supplement

Study groups in NCT02873910
Study groupRoleWhat they receive
IQP-AS-119ExperimentalOne tablet to be taken daily with any meal, with a glass of water. They should not be chewed, but swallowed whole.
Receives: Dietary Supplement: IQP-AS-119
PlaceboPlacebo comparatorOne tablet to be taken daily with any meal, with a glass of water. They should not be chewed, but swallowed whole.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Hooper's Index

    Compared between verum and placebo groups at baseline and all timepoints thereafter.

    Measured: 5 weeks

Secondary outcomes (11)

  1. Perceived Stress Questionnaire (PSQ20)

    Compared between verum and placebo groups at baseline and all timepoints thereafter.

    Measured: 5 weeks

  2. URT symptoms recorded in daily dairy

    Compared between verum and placebo groups at baseline and all timepoints thereafter.

    Measured: 5 weeks

  3. Daily subject diary on URT symptoms and other health conditions (including Overall Treatment Effect (OTE)

    Compared between verum and placebo groups at baseline and all timepoints thereafter.

    Measured: 5 weeks

  4. Wisconsin upper respiratory symptom survey (WURSS-21)

    Compared between verum and placebo groups at baseline and all timepoints thereafter.

    Measured: 5 weeks

  5. Short Form-12 (SF-12) Health Survey

    Compared between verum and placebo groups at baseline and all timepoints thereafter.

    Measured: 5 weeks

  6. Global evaluation of benefit (4-point categorical scale)

    Measured by the subjects/investigator at the final visit only

    Measured: 5 weeks

  7. Blood pressure

    Compared between verum and placebo groups at baseline and all timepoints thereafter.

    Measured: 5 weeks

  8. Pulse rate

    Compared between verum and placebo groups at baseline and all timepoints thereafter.

    Measured: 5 weeks

  9. Body temperature

    Compared between verum and placebo groups at baseline and all timepoints thereafter.

    Measured: 5 weeks

  10. Adverse events (AEs) throughout study

    Compared between verum and placebo groups at baseline and all timepoints thereafter.

    Measured: 5 weeks

  11. Global evaluation of tolerability (4-point categorical scale)

    Measured by the subjects/investigator

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2016 (estimated)
  2. Study start10 Jul 2016
  3. Primary completion31 Oct 2016
  4. Study completion31 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02873910
Sponsor's protocol ID
INQ/009716
Status last verified
Jan 2018
First submitted
8 Aug 2016
Last updated
3 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing IQP-AS-119 in people with Upper Respiratory Tract Symptoms, run by InQpharm Group at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hooper's Index (time frame: 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02873910.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.

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