DysphagiaNCT02422576
Efficacy of Natural Ingredient to Improve the Swallowing Response of Patients With Oropharyngeal Dysphagia
A study testing cinnamon extract, lemon extract and lemon extract plus eucalyptus extract in people with Dysphagia, run by Société des Produits Nestlé (SPN) at 1 site in Spain.
Trial summary
Assessment of the improvement of the safety of the swallowing function under 3 natural ingredients known to be agonist of sensory receptors. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- cinnamon extract, lemon extract and lemon extract plus eucalyptus extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2015to 11 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Assessment of the improvement of the safety of the swallowing function under 3 natural ingredients known to be agonist of sensory receptors.
Read the detailed 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.
- Conditions
- Dysphagia
- Being tested
- cinnamon extract, lemon extract, lemon extract plus eucalyptus extract, Thicken Up clear: TUC
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinnamon extractOther
acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
lemon extractOther
acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
lemon extract plus eucalyptus extractOther
acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
Thicken Up clear: TUCOther
| Study group | Role | What they receive |
|---|---|---|
| Control + Product 1 | Active comparator | Control product (Thicken Up clear: TUC) + natural ingredient 1 (cinnamon extract) Receives: Other: cinnamon extract; Other: Thicken Up clear: TUC |
| Control + Product 2 | Active comparator | Control product (Thicken Up clear: TUC) + natural ingredient 2 (lemon extract) Receives: Other: lemon extract; Other: Thicken Up clear: TUC |
| Control + Product 3 | Active comparator | Control product (Thicken Up clear: TUC) + natural ingredient 3 (lemon extract+eucalyptus extract) Receives: Other: lemon extract plus eucalyptus extract; Other: Thicken Up clear: TUC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to15 min after ingredient ingestion
Secondary outcomes (10)
Swallowing safety-Prevalence of penetration
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.
Measured: up to15 min after ingredient ingestion
Swallowing safety-Prevalence of aspiration
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.
Measured: up to15 min after ingredient ingestion
Efficacy of swallowing function-Severity of the amount of oral and pharyngeal residues
Severity of the amount of oral and pharyngeal residues, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Measured: up to15 min after ingredient ingestion
Efficacy of swallowing function-Prevalence of subjects with oral and pharyngeal residues
Prevalence of subjects with oral and pharyngeal residues, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Measured: up to15 min after ingredient ingestion
Efficacy of swallowing function-Time to upper oesophageal sphincter opening
Time to upper oesophageal sphincter opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Measured: up to15 min after ingredient ingestion
Efficacy of swallowing function-Time to laryngeal vestibule opening
Time to laryngeal vestibule opening, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Measured: up to15 min after ingredient ingestion
Efficacy of swallowing function-time to laryngeal vestibule closure
time to laryngeal vestibule closure, assessed during videofluoroscopic (VF) recording of radio-opaque bolus deglutition.
Measured: up to15 min after ingredient ingestion
Modification of brain physiology response to sensory input:
Amplitude and latency of the 4 peaks of the pharyngeal sensory evoked potentials (PSEP) on EEG.
Measured: up to 20 min after ingredient ingestion
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).
using questionnaire
Measured: ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested
palatability using a questionnaire, assessed during EEG sessions (V3 and V4)
using questionnaire
Measured: ponctually at the end of visits V3 and V4, after the EEG recording lasting about 30 min, during wich the product is ingested
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startMar 2015
- Primary completion12 Jun 2017
- Study completion11 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pere Clavé, Md/PhD, Principal investigator, Hospital de Mataro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422576
- Sponsor's protocol ID
- 14.13.NRC
- Status last verified
- Oct 2017
- First submitted
- 24 Mar 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Natural Ingredient to Improve the Swallowing Response of Patients With Oropharyngeal Dysphagia
- ClinicalTrials.gov ID
- NCT02422576
- Acronym / sponsor ID
- 14.13.NRC
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 11 Sep 2017 (actual)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the improvement of the safety of the swallowing function under 3 natural ingredients known to be agonist of sensory receptors.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control + Product 1 | Active comparator | Other: cinnamon extract, Other: Thicken Up clear: TUCControl product (Thicken Up clear: TUC) + natural ingredient 1 (cinnamon extract) |
| Control + Product 2 | Active comparator | Other: lemon extract, Other: Thicken Up clear: TUCControl product (Thicken Up clear: TUC) + natural ingredient 2 (lemon extract) |
| Control + Product 3 | Active comparator | Other: lemon extract plus eucalyptus extract, Other: Thicken Up clear: TUCControl product (Thicken Up clear: TUC) + natural ingredient 3 (lemon extract+eucalyptus extract) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cinnamon extractacute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity) | Other | Control + Product 1 |
| lemon extractacute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity) | Other | Control + Product 2 |
| lemon extract plus eucalyptus extractacute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity) | Other | Control + Product 3 |
| Thicken Up clear: TUC | Other | Control + Product 1, Control + Product 2, Control + Product 3 |
Primary outcome
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.
10 secondary outcomes
Swallowing safety-Prevalence of penetration
Time frame: up to15 min after ingredient ingestion
Swallowing safety-Prevalence of aspiration
Time frame: up to15 min after ingredient ingestion
Efficacy of swallowing function-Severity of the amount of oral and pharyngeal residues
Time frame: up to15 min after ingredient ingestion
Efficacy of swallowing function-Prevalence of subjects with oral and pharyngeal residues
Time frame: up to15 min after ingredient ingestion
Efficacy of swallowing function-Time to upper oesophageal sphincter opening
Time frame: up to15 min after ingredient ingestion
Efficacy of swallowing function-Time to laryngeal vestibule opening
Time frame: up to15 min after ingredient ingestion
Efficacy of swallowing function-time to laryngeal vestibule closure
Time frame: up to15 min after ingredient ingestion
Modification of brain physiology response to sensory input:
Time frame: up to 20 min after ingredient ingestion
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
Related trials for Dysphagia
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pere Clavé, Md/PhD principal investigator
Hospital de Mataro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cinnamon extract, lemon extract and lemon extract plus eucalyptus extract in people with Dysphagia, run by Société des Produits Nestlé (SPN) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the safety of the swallowing function, according to Rosenbek's scale (time frame: up to15 min after ingredient ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.