Evaluating the Clinical Efficacy and Safety of Colflex

Evaluating the Clinical Efficacy and Safety of Colfelx

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.

Study Overview

• Status: Completed
• Conditions: Personal Satisfaction

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T2N2
      • RCFFN: University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Residents in town

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and duration of colds/sore throats	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of oral pathogenic bacteria	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.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on plasma lipid profile and enzyme measurements	Exploratory efficacy measures include lipid profile, (TC, HDL, TG), and liver enzymes	30 days
Measurement of oral halitosis	A breath sample is taken to measure volatile sulphur compounds using a halimeter.	30 days

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Oral health; Halitosis; Sore throat; Oral bacteria; Mouth health; Colds
• Other Study ID Numbers: B2013:133