Efficacy of Natural Ingredient to Improve the Swallowing Response of Patients With Oropharyngeal Dysphagia

Nestlé

Status: Completed

Conditions: Dysphagia

Treatments: Other: Thicken Up clear: TUC; Other: cinnamon extract; Other: lemon extract plus eucalyptus extract; Other: lemon extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT02422576

14.13.NRC

Details and patient eligibility

About

Assessment of the improvement of the safety of the swallowing function under 3 natural ingredients known to be agonist of sensory receptors.

Full description

The trial will be double-blind, randomized, monocentric, and interventional with a hybrid design. The subjects will be randomized to one of the three parallel active ingredient groups. Products will be compared versus control (Thicken Up Clear - nectar viscosity), which adds a part of cross over within the design.

The total sample size is 84 enrolled subjects. Patients will be males and females aged 55+ with mild proven dysphagia.

Enrollment: 104 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 55+
• Patients showing impaired safety of the deglutition during the V-VST (volume - viscosity swallow test): Cough oxygen desaturation ≥3% or voice change.
• Neurodegenerative or ischemic/hemorrhagic cerebral cause (stroke) or elderly subjects

Exclusion criteria

• Patients radiated for treatment of head and neck cancer Idiosyncrasis
• Allergy to food or medication, especially contrast products (iodine)
• Major respiratory disease needing oxygen as standard treatment.
• Any major and relevant abdominal, head and neck, or chest surgery within the three months preceding the study.
• Have a high alcohol consumption (more than 2 drinks/day)
• Subject who cannot be expected to comply with the study procedures, including consuming the test products.
• Currently participating or having participated in another clinical trial during the month preceding the study
• Patients with relevant mucosal damage or with in-mouth irritation
• Patients with pacemaker or electrode implants
• Epileptic patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

104 participants in 3 patient groups

Control + Product 1

Active Comparator group

Description:

Control product (Thicken Up clear: TUC) + natural ingredient 1 (cinnamon extract)

Treatment:

Other: Thicken Up clear: TUC

Other: cinnamon extract

Control + Product 2

Active Comparator group

Description:

Control product (Thicken Up clear: TUC) + natural ingredient 2 (lemon extract)

Treatment:

Other: lemon extract

Other: Thicken Up clear: TUC

Control + Product 3

Active Comparator group

Description:

Control product (Thicken Up clear: TUC) + natural ingredient 3 (lemon extract+eucalyptus extract)

Treatment:

Other: lemon extract plus eucalyptus extract

Other: Thicken Up clear: TUC