Evaluating the Clinical Efficacy and Safety of Colflex

NCT02011035 | Completed DMC

• 1 other identifier: B2013:133
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Personal Satisfaction

Keywords

Oral health; Mouth health; Halitosis; Oral bacteria; Sore throat; Colds

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of oral pathogenic bacteria

  30 days

Other Outcomes (2)

• Effect on plasma lipid profile and enzyme measurements

  30 days

• Measurement of oral halitosis

  30 days

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Residents in town

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

RCFFN: University of Manitoba

Winnipeg, Manitoba, R3T2N2, Canada

Location

MeSH Terms

Conditions

Personal Satisfaction; Halitosis; Pharyngitis

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Richardson Centre for Functional Foods and Nutraceuticals

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: December 13, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

CA (1)