NCT04901182

Brief 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 elderly people with dysphagia risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 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

January 8, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

May 18, 2021

Last Update Submit

May 20, 2021

Conditions

Dysphagia

Keywords

agingsmoothie drinkdysphagiaswallowing capacity

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Secondary Outcomes (3)

  • Premature spillage of material as assessed by a healthcare professional using the FEES

    Baseline

  • Retention/pooling of material and/or secretion as assessed by a healthcare professional using the FEES

    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

    Baseline

Study Arms (3)

White sesame soy milk smoothie (WS)

ACTIVE COMPARATOR

a formula developed from natural ingredients such as soybean and white sesame

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

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

Diagnostic Test: the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)

Interventions

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)

Chicken shitake smoothie (CS)EnsureWhite sesame soy milk smoothie (WS)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 40604458DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Korapat Mayurasakorn, MD.

    Doctor in Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 25, 2021

Study Start

January 8, 2019

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)