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Completed

NCT Number: NCT02422576

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

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

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cinnamon extract

Other

acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)

lemon extract

Other

acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)

lemon extract plus eucalyptus extract

Other

acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)

Thicken Up clear: TUC

Other

Primary outcomes

  1. Improvement of the safety of the swallowing function, according to Rosenbek's scale

    Time frame: up to15 min after ingredient ingestion

    The maximum PAS score across the different boluses (5, 10 and 20 ml) during nectar series (with and without active ingredient) assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.

Secondary outcomes

  1. Swallowing safety-Prevalence of penetration

    Time frame: up to15 min after ingredient ingestion

    the prevalence of penetration in the population according to Rosenbek's PAS (scores of 2-5)

    , assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.

  2. Swallowing safety-Prevalence of aspiration

    Time frame: up to15 min after ingredient ingestion

    the prevalence of aspiration in the population according to Rosenbek's PAS (scores of 6-8), assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.

  3. Efficacy of swallowing function-Severity of the amount of oral and pharyngeal residues

    Time frame: up to15 min after ingredient ingestion

    Severity of the amount of oral and pharyngeal residues, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.

  4. Efficacy of swallowing function-Prevalence of subjects with oral and pharyngeal residues

    Time frame: up to15 min after ingredient ingestion

    Prevalence of subjects with oral and pharyngeal residues, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.

  5. Efficacy of swallowing function-Time to upper oesophageal sphincter opening

    Time frame: up to15 min after ingredient ingestion

    Time to upper oesophageal sphincter opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.

  6. Efficacy of swallowing function-Time to laryngeal vestibule opening

    Time frame: up to15 min after ingredient ingestion

    Time to laryngeal vestibule opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.

  7. Efficacy of swallowing function-time to laryngeal vestibule closure

    Time frame: up to15 min after ingredient ingestion

    time to laryngeal vestibule closure, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.

  8. Modification of brain physiology response to sensory input:

    Time frame: up to 20 min after ingredient ingestion

    Amplitude and latency of the 4 peaks of the pharyngeal sensory evoked potentials (PSEP) on EEG.

  9. Tolerability to the products (gastrointestinal comfort) using a questionnaire, assessed during EEG sessions (V3 and V4) to avoid capturing side effects of the contrast agent (as nausea).

    Time frame: ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested

    using questionnaire

  10. palatability using a questionnaire, assessed during EEG sessions (V3 and V4)

    Time frame: ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested

    using questionnaire

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 21, 2015
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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