Nutritional Intervention for Older Adults With Complete Dentures

Summary

The purpose of this clinical trial is to test a nutritional intervention. This study helps older adults who wear complete removable dentures improve their health.

The main questions the study aims to answer are:

* What are the participants life experiences living with complete dentures before the intervention?
* Does the intervention improve the diet quality of the participants?
* Does the intervention improve nutritional status of the participants?
* Does the intervention improve chewing performance and muscle strength?
* Does the intervention increase the thickness of the masticatory muscles?
* Does the intervention improve stress and muscle health markers in saliva?
* Does the intervention improve cognitive performance and oral health-related quality of life?
* Does the intervention improve cerebral blood flow? The study will include a total of 40 participants, who will be assigned to two groups. One group of 20 participants will receive the nutritional intervention, while the other group of 20 participants will maintain their usual diet during the study period. This comparison will allow the investigators to assess the effectiveness of the intervention.

Participants will:

* Take part in a personal interview about their life experience with dentures.
* Follow a dietary guide with recommendations on specific food textures for six months.
* Receive personalized nutritional counseling and participate in healthy cooking workshops.
* Use a custom-built mobile application to access the educational content of the nutritional guide, view instructional videos uploaded biweekly, and receive automated reminder notifications.
* Attend clinical follow-up assessments, including chewing performance, muscle assessment, saliva markers, assessment of diet quality and nutritional status, cognitive tests, and oral health-related quality of life.
* Complete these assessments at three main time points: baseline, 3 months, and 6 months.

Conditions

• Mastication Disorder
• Edentulism Complete
• Denture, Complete

Interventions

BEHAVIORAL

Nutritional Intervention

This 6-month nutritional intervention for older adults wearing complete removable dentures consists of 6 components: 1. In-person nutritional consultation: A trained nutritionist will provide dietary guidance, adapt recommendations to individual needs and support the initiation of dietary changes. 2. Telephone follow-up: Monthly counseling sessions to monitor progress, address question and reinforce adherence to the intervention. 3. Dietary guidelines booklet: Includes specific nutritional recommendations, weekly menu proposals, healthy recipes and guidance for incorporating foods with different textures and hardness levels, with the aim of stimulating masticatory function according to individual tolerance. 4. Cooking workshop: Will teach participants how to prepare the recipes included in the dietary guidelines booklet. 5. Food box delivery: Monthly supply of non-perishable ingredients. 6. Mobile app: Digital tool providing the digital guide, educational videos and push notifications.

Sponsors & Collaborators

• Agencia Nacional de Investigación y Desarrollo

  collaborator OTHER

• Universidad de La Frontera

  lead OTHER

Principal Investigators

• Ramón Fuentes, PhD · Universidad de La Frontera

• Camila Venegas, MSc · Universidad de La Frontera

• Gladys Morales, PhD · Universidad de La Frontera

• Carlos Zaror, PhD · Universidad de La Frontera

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-09

Primary Completion

2028-05-12

Completion

2028-05-12

Countries

• Chile

Study Locations