Evaluating the Clinical Efficacy and Safety of Colflex

Personal Satisfaction Clinical Trial

Official title:

Evaluating the Clinical Efficacy and Safety of Colfelx

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011035
• Other study ID #: B2013:133
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2013
• Last updated: March 25, 2015
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Personal Satisfaction

Locations

Country	Name	City	State
Canada	RCFFN: University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect on plasma lipid profile and enzyme measurements	Exploratory efficacy measures include lipid profile, (TC, HDL, TG), and liver enzymes	30 days	No
Other	Measurement of oral halitosis	A breath sample is taken to measure volatile sulphur compounds using a halimeter.	30 days	No
Primary	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	No
Secondary	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	No