DysphagiaNCT04901182

Nutrition-dense Smoothie Diets Reduced Dysphagia Risk in the Elderly

A study testing the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES) in people with Dysphagia, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators aimed to compare the effect of consuming high protein (23-34% energy ratio) and low carbohydrate (25-38% energy ratio) smoothie formulas vs. consuming Ensure (a conventional well-known commercial formula) on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES) in the… Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Dysphagia
What is being tested?: the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 1 siteThailand
Study dates: 8 Jan 2019to 30 Apr 2019
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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

swallowing difficulty group (SSD) who with symptomatic swallowing difficulties or with a history of swallowing difficulties, coughing or choking when eating or drinking or a sign of malnutrition
control group (WSD) who without a history of swallowing difficulties, coughing or choking when eating or drinking or a sign of malnutrition

Who cannot join

People with chronic illnesses and tube feeding
People with anterior bone deformity e.g. facial fracture, sino-nasal or anterior skill-based tumor/surgery

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700

Other trials in Thailand

About this study

Official title: The Effect of Nutrition-dense, Blenderized Enteral Nutrition From Natural Ingredients on Swallowing Capacity to Prevent Suffocation in the Elderly by Using Flexible Endoscopic Examination of Swallowing (FEES)

Read the detailed description

The investigators aimed to determine the effect of 3 high protein (23-34% energy ratio) and low carbohydrate (25-38% energy ratio) smoothie formulas ((1) white sesame soy milk smoothie (WS), (2) black sesame soy milk smoothie (low carbohydrate, BSLC), and (3) Chicken shitake smoothie (CS); 1 kcal/ml) from natural ingredients as compared with Ensure. The double blind randomized placebo controlled cross-over design study involved 63 subjects aged above 65 years old. They were also divided into asymptomatic (n=32) or symptomatic swallowing difficulty (n=31) group based on self-reported swallowing difficulty symptoms. All subjects assessed five drinks (WS, BSLC, CS vs. Ensure) for sensory testing, product acceptance and marketing survey using questionnaires. Swallowing capacity was determined by using Flexible Endoscopic Examination of Swallowing (FEES) only for each of the three drinks (SW, CS vs. Ensure) in a blinded random sequence.

Conditions: Dysphagia
Being tested: the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)
Keywords: aging, smoothie drink, dysphagia, swallowing capacity
Medical subject headings: Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)Diagnostic test
the effect of consuming white sesame soy milk smoothie (WS), Chicken shitake smoothie (CS) vs. Ensure on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)

Study groups in NCT04901182
Study group	Role	What they receive
White sesame soy milk smoothie (WS)	Active comparator	a formula developed from natural ingredients such as soybean and white sesame Receives: Diagnostic Test: the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)
Chicken shitake smoothie (CS)	Active comparator	a formula developed from natural ingredients such as chicken and shitake mushroom Receives: Diagnostic Test: the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)
Ensure	Placebo comparator	a conventional well-known commercial formula Receives: Diagnostic Test: the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)

What is being measured

The primary outcome is the main question the study is designed to answer.

Level of severity of dysphagia as assessed by a healthcare professional using the FEES
Sum of FEES score from three symptoms consists of premature spillage of material, retention/pooling of material and/or secretion, and entrance of material and/or secretion into the larynx or trachea.
A healthcare professional evaluated in the five-point scoring system of each symptom.
FEES score = 5 means there were not exhibit disorder, FEES score = 1 means there were abnormalities at severe level
Measured: Baseline

Secondary outcomes (3)

Premature spillage of material as assessed by a healthcare professional using the FEES
levels of severity of food passed down through the pharynx before swallowing using the five-point scoring system FEES score = 5 means there were not exhibit disorder, FEES score = 1 means there were abnormalities at severe level
Measured: Baseline
Retention/pooling of material and/or secretion as assessed by a healthcare professional using the FEES
levels of severity of food or saliva residue in the vallecular and/or pyriform regions of the pharynx after swallowing using the five-point scoring system FEES score = 5 means there were not exhibit disorder, FEES score = 1 means there were abnormalities at severe level
Measured: Baseline
Entrance of material and/or secretion into the larynx or trachea; presence/absence of reflex cough as assessed by a healthcare professional using the FEES
levels of severity of food passes through the larynx or trachea when swallowed with or without the cough reflex using the five-point scoring system FEES score = 5 means there were not exhibit disorder, FEES score = 1 means there were abnormalities at severe level
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 201930 Apr 2019

First posted25 May 2021
Study start8 Jan 2019
Primary completion30 Apr 2019
Study completion30 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DysphagiaStudies of the same condition, open and under way.
More trials run by Mahidol UniversityThe 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04901182
Sponsor's protocol ID: 460/2560(EC3)
Status last verified: May 2021
First submitted: 18 May 2021
Last updated: 25 May 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mongkolsucharitkul P, Pinsawas B, Watcharachaisoponsiri T, Suta S, Pumeiam S, Ophakas S, Surawit A, Ongard S, Keskool P, Thitisakulchai P, Srichayet P, Mayurasakorn K. Evaluating swallowing capacity in older adults with dysphagia: high protein, low carbohydrate smoothie formulas versus commercial formula. BMC Geriatr. 2025 Jul 2;25(1):456. doi: 10.1186/s12877-025-06126-x.
PubMed 40604458

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Nutrition-dense, Blenderized Enteral Nutrition From Natural Ingredients on Swallowing Capacity to Prevent Suffocation in the Elderly by Using Flexible Endoscopic Examination of Swallowing (FEES)
ClinicalTrials.gov ID: NCT04901182
Acronym / sponsor ID: 460/2560(EC3)
Conditions: Dysphagia
Keywords: aging, smoothie drink, dysphagia, swallowing capacity
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Mahidol UniversityUniversity, hospital or other
Study start: 8 Jan 2019 (actual)
Primary completion: 30 Apr 2019 (actual)
Study completion: 30 Apr 2019 (actual)
First posted: 25 May 2021 (actual)
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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
White sesame soy milk smoothie (WS)	Active comparator	Diagnostic Test: the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)a formula developed from natural ingredients such as soybean and white sesame
Chicken shitake smoothie (CS)	Active comparator	Diagnostic Test: the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)a formula developed from natural ingredients such as chicken and shitake mushroom
Ensure	Placebo comparator	Diagnostic Test: the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)a conventional well-known commercial formula

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (2 listed)

swallowing difficulty group (SSD) who with symptomatic swallowing difficulties or with a history of swallowing difficulties, coughing or choking when eating or drinking or a sign of malnutrition
control group (WSD) who without a history of swallowing difficulties, coughing or choking when eating or drinking or a sign of malnutrition

Key exclusion criteria (2 listed)

People with chronic illnesses and tube feeding
People with anterior bone deformity e.g. facial fracture, sino-nasal or anterior skill-based tumor/surgery

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
the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)the effect of consuming white sesame soy milk smoothie (WS), Chicken shitake smoothie (CS) vs. Ensure on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)	Diagnostic test	Chicken shitake smoothie (CS), Ensure, White sesame soy milk smoothie (WS)

Primary outcome

Level of severity of dysphagia as assessed by a healthcare professional using the FEES
Time frame: Baseline
Sum of FEES score from three symptoms consists of premature spillage of material, retention/pooling of material and/or secretion, and entrance of material and/or secretion into the larynx or trachea. A healthcare professional evaluated in the five-point scoring system of each symptom. FEES score = 5 means there were not exhibit disorder, FEES score = 1 means there were abnormalities at severe level

3 secondary outcomes

Premature spillage of material as assessed by a healthcare professional using the FEES
Time frame: Baseline
Retention/pooling of material and/or secretion as assessed by a healthcare professional using the FEES
Time frame: Baseline
Entrance of material and/or secretion into the larynx or trachea; presence/absence of reflex cough as assessed by a healthcare professional using the FEES
Time frame: Baseline

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 25 May 2021.
Derived from this study: PubMed 40604458Mongkolsucharitkul P, Pinsawas B, Watcharachaisoponsiri T, Suta S, Pumeiam S, Ophakas S, Surawit A, Ongard S, Keskool P, Thitisakulchai P, Srichayet P, Mayurasakorn K. Evaluating swallowing capacity in older adults with dysphagia: high protein, low carbohydrate smoothie formulas versus commercial formula. BMC Geriatr. 2025 Jul 2;25(1):456. doi: 10.1186/s12877-025-06126-x.
Individual participant dataSharing planned: No

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
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Recruiting
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Not yet recruitingPhase 2
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Active, not recruitingObservational study
RETHINK REFLUX Registry
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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.

Korapat Mayurasakorn, MD. principal investigator

Doctor in Family Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 2 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 25 May 2021. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?

Level of severity of dysphagia as assessed by a healthcare professional using the FEES (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04901182, which also lists 1 linked publication.

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 25 May 2021.