Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity

Study Overview
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Brief Summary
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This study is to investigate whether a candy can increase moisture of the oral cavity and reduce dryness of mouth.

Detailed Description
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A candy (available on the market from a Swiss manufacturer (Ricola)), free of ingredients that could interfere with the investigation, is tested in five different versions on different days. It is to analyse whether these candies can increase moisture of the oral cavity and reduce dryness of mouth.

Official Title
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Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity (DESERTO)

Conditions
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Xerostomia, Dryness of Mouth

Intervention / Treatment
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* Other: V01 candy
* Other: V02 candy
* Other: V03 candy
* Other: V04 candy
* Other: V05 candy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non- smoker no allergies no drug- use (except for contraception) healthy volunteers (no disease/infection 4 weeks before study participation) Exclusion Criteria: pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: doppel- blind testing of 5 different variations of a candy in each participant by (unstimulated and stimulated) salivary flow rate; each participant is testing each variation of candy once in a randomized order at 5 consecutive days
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy participants starting with candy V01<br>healthy participants testing a candy in 5 different variations by (unstimulated and stimulated) salivary flow rate (before and after comparison) | Other: V01 candy<br>* candy with sweetener (Isomalt) and apple flavour<br>Other: V02 candy<br>* candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)<br>Other: V03 candy<br>* candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C<br>Other: V04 candy<br>* candy with sweetener (Isomalt) (control group 1)<br>Other: V05 candy<br>* candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)<br>|
| Experimental: healthy participants starting with candy V02<br> | Other: V01 candy<br>* candy with sweetener (Isomalt) and apple flavour<br>Other: V02 candy<br>* candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)<br>Other: V03 candy<br>* candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C<br>Other: V04 candy<br>* candy with sweetener (Isomalt) (control group 1)<br>Other: V05 candy<br>* candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)<br>|
| Experimental: healthy participants starting with candy V03<br> | Other: V01 candy<br>* candy with sweetener (Isomalt) and apple flavour<br>Other: V02 candy<br>* candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)<br>Other: V03 candy<br>* candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C<br>Other: V04 candy<br>* candy with sweetener (Isomalt) (control group 1)<br>Other: V05 candy<br>* candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)<br>|
| Experimental: healthy participants starting with candy V04<br> | Other: V01 candy<br>* candy with sweetener (Isomalt) and apple flavour<br>Other: V02 candy<br>* candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)<br>Other: V03 candy<br>* candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C<br>Other: V04 candy<br>* candy with sweetener (Isomalt) (control group 1)<br>Other: V05 candy<br>* candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)<br>|
| Experimental: healthy participants starting with candy V05<br> | Other: V01 candy<br>* candy with sweetener (Isomalt) and apple flavour<br>Other: V02 candy<br>* candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)<br>Other: V03 candy<br>* candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C<br>Other: V04 candy<br>* candy with sweetener (Isomalt) (control group 1)<br>Other: V05 candy<br>* candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dryness of mouth- sensation | dryness of mouth- sensation by Visual analogue scale (VAS); 0 = does not apply; 10 = is absolutely true. | one point assessment following consumption of candy (approx 5 minutes) | 
| Change in salivary flow rate (ml/min) | Change in salivary flow rate (ml/min) before and after stimulation (mechanical and gustatory) by consumption of candy | before and after consumption of candy (approx 5 minutes for each salivary flow measurement) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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salivary flow rate, salivary flow stimulation