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This study is designed to evaluate the effect of an investigational lozenge with the enzyme polyphenol oxidase and green coffee extract in reducing and controlling intra-oral halitosis following immediate use and daily use of the lozenge over a one-week period.
This randomized, placebo controlled, double-blind, crossover study will use gas chromatography (GC) and oral microbial measurements to evaluate the reduction and control of intra-oral halitosis by an investigational lozenge containing the enzyme polyphenol oxidase and green coffee extract compared to a placebo control lozenge. A one-week washout period will precede the first crossover period and a one-week washout period will be implemented between periods 1 and 2. The study will consist of five study visits: Screening Visit, Period 1 Baseline Visit, Crossover Period 1 Day 8 Visit, Period 2 Baseline Visit, Crossover Period 2 Day 8 Visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational lozenge | Active Comparator | Lozenge containing the enzyme polyphenol oxidase and green coffee extract |
|
| Placebo lozenge | Placebo Comparator | Lozenge equal to active comparator but without active ingredients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofresh® 4plus | Dietary Supplement | Participants will be instructed to use their assigned lozenge three times per day for seven days, preferably after breakfast, lunch, and dinner meals and to avoid eating and drinking for 30 minutes after consuming the lozenge. |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate Total Volatile Sulphur Compounds (T-VSC) | The primary efficacy endpoint is the immediate (no later than 5 minutes after dissolution of the lozenge) T-VSCs at Day 1 based on OralChromaâ„¢ measurement. | The change in T-VSCs from baseline to 5-minutes post-product assessment |
| Measure | Description | Time Frame |
|---|---|---|
| T-VSCs over time | T-VSCs over time, based on OralChromaâ„¢ following daily product use | The change in T-VSCs over time from baseline to 1 hour, 2 hours, 4 hours (Day 1), and 7 days post-product assessments |
| Specific VSCs over time |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Interviews to determine adverse events | Day 1 (4 hours) and Day 8 |
To be eligible for study participation, subjects must meet the following criteria:
Inclusion criteria:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Caterina Holz, PhD | Novozymes A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research | Fort Wayne | Indiana | 46825 | United States |
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| ID | Term |
|---|---|
| D006209 | Halitosis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Dietary Supplement | Participants will be instructed to use their assigned lozenge three times per day for seven days, preferably after breakfast, lunch, and dinner meals and to avoid eating and drinking for 30 minutes after consuming the lozenge. |
|
VSCs components [Hydrogen Sulfide (H2S), Methyl Mercaptan (CH3SH), and Dimethyl Sulfide (CH3SCH3) gases] over time following daily product use
| The change in specific VSCs over time from baseline to 1 hour, 2 hours, 4 hours (Day 1), and 7 days post-product assessments |
| Questionnaire | Post-product use questionnaire | Day 1 and Day 8 |
| Oral microbiome composition | Microbiome profile by 16S rRNA sequencing, saliva and tongue biofilm samples collected | Day 1 (pre and immediate post-product use, 5 minutes) and Day 8 |