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

NCT02873910 | Completed

• 1 other identifier: INQ/009716
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Upper Respiratory Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• Change in Hooper's Index

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

  5 weeks

Secondary Outcomes (11)

• Perceived Stress Questionnaire (PSQ20)

  5 weeks

• URT symptoms recorded in daily dairy

  5 weeks

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

  5 weeks

• Wisconsin upper respiratory symptom survey (WURSS-21)

  5 weeks

• Short Form-12 (SF-12) Health Survey

  5 weeks

Study Arms (2)

IQP-AS-119

EXPERIMENTAL

One tablet to be taken daily with any meal, with a glass of water. They should not be chewed, but swallowed whole.

Dietary Supplement: IQP-AS-119

Placebo

PLACEBO COMPARATOR

One tablet to be taken daily with any meal, with a glass of water. They should not be chewed, but swallowed whole.

Dietary Supplement: Placebo

Interventions

IQP-AS-119 DIETARY_SUPPLEMENT

IQP-AS-119

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InQpharm Group: lead

Study Sites (1)

analyze & realize GmbH

Berlin, 10369, Germany

Location

Study Officials

• Ralf Uebelhack, MD, PhD

  analyze & realize GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 22, 2016
• Study Start: July 10, 2016
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: January 3, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)