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

N

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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