Evaluating the Clinical Efficacy and Safety of Colflex

Evaluating the Clinical Efficacy and Safety of Colfelx

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02011035

Enrollment

Registered

2013-12-13

Start date

2013-11-30

Completion date

2014-03-31

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Personal Satisfaction

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

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

Countries

Canada

Outcome results