Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-05-01
Brief Title:
Impact of Ultra-Processed Food Intake on Gingival Tissue Health
Sponsor:
University of Siena
Organization:
University of Siena
Study Overview
Official Title:
Impact of Ultra-Processed Food Intake on Gingival Tissue Health A Pre-post Clinical Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The shift towards consuming more industrialized food products particularly ultra-processed foods has been linked to a rise in non-communicable diseases globally These products are energy-dense high in unhealthy components and often lead to overconsumption due to their palatability and convenience Studies suggest a connection between ultra-processed food consumption and various health issues including obesity and cardiovascular diseases The present study is designed as a single-center double-blind parallel-arm randomized clinical trial This study aims to investigate the impact of ultra-processed food consumption on gingival health and to evaluate the potential benefits of dietary counseling and reduced ultra-processed food intake on gingival inflammation over a 4-month period
Detailed Description:
The impact of shifting of a diet from less industrialized food products toward a more industrialized food products has a positive relationship to the global burden of non- communicable disease This increase in the consumption of Ultra-Process food was first started in the high-income countries and now in medium-income countries All together they are energy dense high in unhealthy types of fat refined starches free sugars and salt and poor sources of protein dietary fibre Ultra-processed products are made to be hyper-palatable and attractive with long shelf-life and able to be consumed anywhere any time Their formulation presentation and marketing often promote overconsumption Due to the high levels of additives sugars and preservatives they have been associated with various non-communicable diseases including obesity cardiovascular diseases and systemic inflammation like periodontitis In order to investigate a relationship between ultra-process food consumption and gingival health we used a food frequency questionnaire conducted and evaluated in a study in south of Italy with the classification of food according to the NOVA classification
In recent years the effect of ultra-processed foods consumption on systemic and oral health has received more attention Several studies have reported a significant association between caries and ultra-processed food However the effect of an highly processed food diet on gingival tissues health has not been fully investigated Thus the aim of the present study is to assess the impact of ultra-processed food consumption on gingival inflammation
Primary Objective
To assess the association between ultra-processed food intake and the health of gingival tissues of a University-based cohort of individuals
Secondary Objectives
To determine the role of dietary counselling and reduced ultra-processed food consumption on the resolution of gingival inflammation
Trial design The current protocol is designed as single-centre double-blind parallel arm University-based superiority clinical trial with a 4-month follow up
In recent years the effect of ultra-processed foods consumption on systemic and oral health has received more attention Several studies have reported a significant association between caries and ultra-processed food However the effect of an highly processed food diet on gingival tissues health has not been fully investigated Thus the aim of the present study is to assess the impact of ultra-processed food consumption on gingival inflammation
Primary Objective
To assess the association between ultra-processed food intake and the health of gingival tissues of a University-based cohort of individuals
Secondary Objectives
To determine the role of dietary counselling and reduced ultra-processed food consumption on the resolution of gingival inflammation
Trial design The current protocol is designed as single-centre double-blind parallel arm University-based superiority clinical trial with a 4-month follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None