Effect of Sour Cherry Anthocyanins on Healthy Human Saliva

Dental Caries Clinical Trial

Official title:

Effect of Sour Cherry Anthocyanins (Cyanidin Components of Sour Cherry) on Human Saliva and Biofilm Formation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05406011
• Other study ID #: 2022-IV/1120-1/2020
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 16, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: University of Debrecen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The experiment is based on earlier research where it was proven that chewing gum usage with anthocyanin rich sour cherry extract significantly reduces the amount of human salivary alpha-amylase in unstimulated saliva samples and stimulated saliva samples taken in every 10 minutes till a half an hour as compared to placebo. The S. mutans counts' number on agar base cultures were greater in case of the stimulated samples of placebo and anthocyanin containing chewing gum groups. The investigators' aims were to extend the background of the earlier established phenomena: The sour cherry (anthocyanin) containing chewing gum usage (around 2 weeks, daily 3 times) is beneficent on the human oral microflora and cytokine level/expression.

Description:

The experiment is based on earlier research where it was proven that chewing gum usage with anthocyanin rich sour cherry extract significantly reduces the amount of human salivary alpha-amylase in unstimulated saliva samples and stimulated saliva samples taken in every 5 minutes till a half an hour as compared to placebo. The investigators' study: Examination the effect of sour cherry anthocyanin containing chewing gum in a study taking a 3-week experimental period. At the beginning of experimental period oral and basic periodontal examination of the participants. Selection of healthy young adults (10 person) and adults (10 person), who has good oral hygiene, do not suffer from serious general disease and do not get respiratory infection treated with antibiotics in the past 2 months. Arranging saliva sampling on fixed appointments (between 12:00 and 14:00, 1st, 4th and 7th day of the week) through 3 weeks. On the 1. week, which is a control period taking of resting saliva samples and stimulated saliva samples from the participants. The stimulated saliva sampling is made after chewing of a gum without active ingredient. At the end of the control week a full mouth scaling is made and after it all of the participants get sour cherry containing chewing gums to chew 3x daily till 2 weeks, and the sampling occasions arranged on the same days as on the control week. After scaling 10 participant change their toothbrush, and 10 do not change. The saliva sample analyzation is placed in the Institute of Food Technology, the Department of Human Genetics and Department of Microbiology where they are frozen on -80 Celsius till the laboratory analysis. 16S (16 Svedberg) rRNA (ribosomal ribonucleic acid) sequencing is starting with DNA isolation by Inhibitor Removal Technology followed by sequencing with Illumina MiSeqSystem. PCR (Polymerase Chain Reaction) analysis of saliva samples starting with RNA isolation of samples with MagMAX Viral Kit, followed by RNA transcription and qPCR (quantitative polymerase chain reaction ) according to the Manufacturer's Instructions. ELISA (Enzyme Linked Immunosorbent Assay) analysis with appropriate saliva analyzation kit for the listed cytokines as follows: Examined cytokines (PCR and ELISA): Interleukins: Interleukin-1β, Interleukin-2, Interleukin-6; TNF(tumor necrosis factor) alfa, Melatonin (ELISA) , Mucin 7 (ELISA) and Mucin-5B (5subtypeB) (ELISA). The investigators' aims to are to extend the background of the earlier established phenomena: The sour cherry (anthocyanin) containing chewing gum usage (around 2 weeks, daily 3 times) is beneficent on the human oral microflora and cytokine level/expression.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• persons over than 18 years of age with a maximum age of 45 years,
• written informed consent,
• healthy dentition

Exclusion Criteria:

• smoking,
• infectious disease treated with antibiotic in the last two months,
• xerostomia,
• acute oral lesion,
• allergy (lactose),
• systemic or mental condition which contraindicate the participation.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Dietary Supplement:
• Pelleted sour cherry (anthocyanin) containing chewing gum usage.
Dietary Supplement usage (daily 3 times for 2 weeks) with salivary sampling on fixed days (1., 4. and 7.) and daytime (between 12:00 and 14:00) of the week. Procedure: Scaling after a control period without sour cherry chewing gum usage (1 week).
• Pelleted chewing gum for stimulated saliva sampling.
Stimulated saliva sampling after chewing a pelleted gum without active ingredient (used only before stimulated saliva sampling), during the whole experimental period (control and parallel with sour cherry chewing gum usage) with sampling on fixed days (1., 4. and 7.) and daytime (between 12:00 and 14:00) of the week.

Procedure:
• Scaling
Scaling after a 1-week control period without chewing the sour cherry gum.

Locations

Country	Name	City	State
Hungary	University of Debrecen	Debrecen

Sponsors (1)

Lead Sponsor	Collaborator
University of Debrecen

Country where clinical trial is conducted

Hungary, 

References & Publications (2)

Homoki J , Gyemant G , Balogh P , Stundl L , Biro-Molnar P , Paholcsek M , Varadi J , Ferenc F , Kelentey B , Nemes J , Remenyik J . Sour cherry extract inhibits human salivary alpha-amylase and growth of Streptococcus mutans (a pilot clinical study). Food Funct. 2018 Jul 17;9(7):4008-4016. doi: 10.1039/c8fo00064f. — View Citation

Homoki JR, Nemes A, Fazekas E, Gyemant G, Balogh P, Gal F, Al-Asri J, Mortier J, Wolber G, Babinszky L, Remenyik J. Anthocyanin composition, antioxidant efficiency, and alpha-amylase inhibitor activity of different Hungarian sour cherry varieties (Prunus cerasus L.). Food Chem. 2016 Mar 1;194:222-9. doi: 10.1016/j.foodchem.2015.07.130. Epub 2015 Jul 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries preventive action of sour cherry chewing gum	The action of sour cherry anthocyanins on human salivary microbiome.	"Through 3 weeks of the study!"
Primary	Action of sour cherry chewing gum in caries prevention	The action of sour cherry anthocyanins on cytokine's level.	"During 3 study weeks!"
Primary	Effect of sour cherry chewing gum in caries prevention	The action of sour cherry anthocyanins on mRNA (messenger ribonucleic acid) expression.	"Through study completion (3 weeks)!"
Secondary	Additional caries preventive action of toothbrush change during sour cherry chewing gum usage	The effect of toothbrush change on human salivary microbiome.	"Till 3 weeks of the study!"
Secondary	Additional effect of toothbrush change in caries prevention during sour cherry chewing gum usage	The effect of toothbrush change on salivary cytokine's level.	"During 3 study weeks!"
Secondary	Additional action of toothbrush change in caries prevention during sour cherry chewing gum usage	The effect of toothbrush change on salivary mRNA expression.	"Through study completion (3 weeks)!"