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Completed

NCT Number: NCT02011035

Evaluating the Clinical Efficacy and Safety of Colflex

This study is designed to test the safety and efficacy of Colflex, an oral spray created by Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and sore throats, as well as dental and oral health changes.

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Key information

Conditions

Personal Satisfaction Behavior Halitosis Infections Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

RCFFN: University of Manitoba

Winnipeg, Manitoba, R3T2N2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • availability to give written consent
  • age 18-60, men and women (who are not pregnant or nursing)
  • people in good health
  • able to follow protocol
  • must be experiencing a sore throat or cold at least once a year

Exclusion criteria

  • smokers
  • liver and kidney disease
  • inflammatory bowel disease
  • pancreatitis
  • gallbladder or biliary disease
  • neurolgical/psychological disease
  • bleeding disorders
  • platelet abnormatilies
  • gastrointestinal disorders that could interfere with fat absorption
  • serum triglycerides > 500 mg/dL and/or total cholesterol > 300 mg/dL
  • hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 Hg
  • BMI >30
  • consume or planned to consume anticoagulant, hypertension, or lipid lowering medications
  • reported consumption of more than 2 alcoholic drinks/day or history of alcoholism or drug dependence
  • reported use of experimental medication within 1 month prior to the trial

Treatment and study plan

Primary outcomes

  1. Frequency and duration of colds/sore throats

    Time frame: 30 days

    Using a self-reported scale to assess the frequency and during of colds and sore throats at screening, and at baseline and endpoint of treatments

Secondary outcomes

  1. Assessment of oral pathogenic bacteria

    Time frame: 30 days

    A mouth swab will be taken to measure pathogenic bacteria (Straph, Strep), and a mouth swab will be used for the BANA test to test for periodontal disease causing bacteria.

Other outcomes

  1. Effect on plasma lipid profile and enzyme measurements

    Time frame: 30 days

    Exploratory efficacy measures include lipid profile, (TC, HDL, TG), and liver enzymes

  2. Measurement of oral halitosis

    Time frame: 30 days

    A breath sample is taken to measure volatile sulphur compounds using a halimeter.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Evaluating the Clinical Efficacy and Safety of Colfelx

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2013
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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