Evaluating the Clinical Efficacy and Safety of Colflex

Completed

• Conditions: Personal Satisfaction

• Registration Number: NCT02011035
• Lead Sponsor: University of Manitoba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-30
• Study Start: 2013-11
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-13
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency and duration of colds/sore throats	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 Outcome Measures

Name	Time	Method
Assessment of oral pathogenic bacteria	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.

Trial Locations

Locations (1)

RCFFN: University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada