NCT02422576

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

2.3 years

First QC Date

March 24, 2015

Last Update Submit

October 25, 2017

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

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

    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.

    up to15 min after ingredient ingestion

Secondary Outcomes (10)

  • Swallowing safety-Prevalence of penetration

    up to15 min after ingredient ingestion

  • Swallowing safety-Prevalence of aspiration

    up to15 min after ingredient ingestion

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

    up to15 min after ingredient ingestion

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

    up to15 min after ingredient ingestion

  • Efficacy of swallowing function-Time to upper oesophageal sphincter opening

    up to15 min after ingredient ingestion

  • +5 more secondary outcomes

Study Arms (3)

Control + Product 1

ACTIVE COMPARATOR

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

Other: cinnamon extractOther: Thicken Up clear: TUC

Control + Product 2

ACTIVE COMPARATOR

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

Other: lemon extractOther: Thicken Up clear: TUC

Control + Product 3

ACTIVE COMPARATOR

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

Other: lemon extract plus eucalyptus extractOther: Thicken Up clear: TUC

Interventions

cinnamon extractOTHER

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

Control + Product 1
lemon extractOTHER

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

Control + Product 2
lemon extract plus eucalyptus extractOTHER

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

Control + Product 3
Thicken Up clear: TUCOTHER
Control + Product 1Control + Product 2Control + Product 3

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

lemon balm leaf extract

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Pere Clavé, Md/PhD

    Hospital de Mataro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2015

First Posted

April 21, 2015

Study Start

March 1, 2015

Primary Completion

June 12, 2017

Study Completion

September 11, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

ES(1)