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Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia

N

Nestlé

Status

Completed

Conditions

Dysphagia
Stroke

Treatments

Other: Cereal extract concentration 1
Other: Cereal extract concentration 3
Other: Thicken up clear concentration 1
Other: Cereal extract concentration 2
Other: Thicken up clear concentration 3
Other: Thicken up clear concentration 2

Study type

Interventional

Funder types

Industry

Identifiers

NCT02522351
13.21. NRC

Details and patient eligibility

About

The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of swallowing in patients having dysphagia problems.

Full description

This trial will be a double blind, randomized, crossover, controlled, and interventional trial. Each subject will test 6 study samples in a randomized order at 5 mL of volume first then at 10 mL (12 samples maximum). The trial will last a maximum of one hour (a single study visit).

The total sample size is 47 enrolled subjects, 33 subjects completed. Patients will be females and males aged between 18 and 85 years with mild proven dysphagia.

Read more

Enrollment

35 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Mild dysphagia as defined by a score between 3 and 5 on the Dysphagia Outcome and Severity Scale
  2. Patients aged between 18 and 85 years
  3. Ischemic/hemorrhagic cerebral cause (stroke)
  4. Able to understand French (oral and written)
  5. Cognitive capacity enough to understand study procedures
  6. Having health insurance (which in France is " social security")
  7. Having signed the consent form.

Exclusion criteria

  1. Any swallowing trouble not resulting from the current stroke
  2. History of inhalation pneumopathy, i.e. any pulmonary inflammation linked to the path of a solid or liquid food in the respiratory system
  3. Any physician diagnosed psychiatric illness
  4. Patient with a digestive fistula
  5. Any physician diagnosed food allergy
  6. Any known allergy to barium or any compound of the contrast product
  7. Confirmed or suspected perforated and occlusive syndrome
  8. Pregnant or lactating women
  9. Major respiratory disease needing oxygen (chronic respiratory insufficiency)
  10. Subject who cannot be expected to comply with the study procedures, including consuming the test products.
  11. Currently participating or having participated in another clinical trial during the month preceding the study

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

35 participants in 6 patient groups

Thicken Up Clear concentration 1
Active Comparator group
Description:
Thicken Up Clear at concentration 1
Treatment:
Other: Cereal extract concentration 1
Other: Cereal extract concentration 3
Other: Cereal extract concentration 2
Other: Thicken up clear concentration 3
Other: Thicken up clear concentration 2
Thicken Up Clear concentration 2
Active Comparator group
Description:
Thicken Up Clear at concentration 2
Treatment:
Other: Cereal extract concentration 1
Other: Cereal extract concentration 3
Other: Thicken up clear concentration 1
Other: Cereal extract concentration 2
Other: Thicken up clear concentration 3
Thicken Up Clear concentration 3
Active Comparator group
Description:
Thicken Up Clear at concentration 3
Treatment:
Other: Cereal extract concentration 1
Other: Cereal extract concentration 3
Other: Thicken up clear concentration 1
Other: Cereal extract concentration 2
Other: Thicken up clear concentration 2
Cereal extract concentration 1
Experimental group
Description:
Cereal extract at concentration 1
Treatment:
Other: Cereal extract concentration 3
Other: Thicken up clear concentration 1
Other: Cereal extract concentration 2
Other: Thicken up clear concentration 3
Other: Thicken up clear concentration 2
Cereal extract concentration 2
Experimental group
Description:
Cereal extract at concentration 2
Treatment:
Other: Cereal extract concentration 1
Other: Cereal extract concentration 3
Other: Thicken up clear concentration 1
Other: Thicken up clear concentration 3
Other: Thicken up clear concentration 2
Cereal extract concentration 3
Experimental group
Description:
Cereal extract at concentration 3
Treatment:
Other: Cereal extract concentration 1
Other: Thicken up clear concentration 1
Other: Cereal extract concentration 2
Other: Thicken up clear concentration 3
Other: Thicken up clear concentration 2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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