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Nutrition-dense Smoothie Diets Reduced Dysphagia Risk in the Elderly

Primary Purpose

Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dysphagia focused on measuring aging, smoothie drink, dysphagia, swallowing capacity

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

White sesame soy milk smoothie (WS)

Chicken shitake smoothie (CS)

Ensure

Arm Description

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

a formula developed from natural ingredients such as chicken and shitake mushroom

a conventional well-known commercial formula

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
May 18, 2021
Last Updated
May 20, 2021
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04901182
Brief Title
Nutrition-dense Smoothie Diets Reduced Dysphagia Risk in the Elderly
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
aging, smoothie drink, dysphagia, swallowing capacity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
White sesame soy milk smoothie (WS)
Arm Type
Active Comparator
Arm Description
a formula developed from natural ingredients such as soybean and white sesame
Arm Title
Chicken shitake smoothie (CS)
Arm Type
Active Comparator
Arm Description
a formula developed from natural ingredients such as chicken and shitake mushroom
Arm Title
Ensure
Arm Type
Placebo Comparator
Arm Description
a conventional well-known commercial formula
Intervention Type
Diagnostic Test
Intervention Name(s)
the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Level of severity of dysphagia as assessed by a healthcare professional using the FEES
Description
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
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Premature spillage of material as assessed by a healthcare professional using the FEES
Description
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
Time Frame
Baseline
Title
Retention/pooling of material and/or secretion as assessed by a healthcare professional using the FEES
Description
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
Time Frame
Baseline
Title
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
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: People with chronic illnesses and tube feeding People with anterior bone deformity e.g. facial fracture, sino-nasal or anterior skill-based tumor/surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Korapat Mayurasakorn, MD.
Organizational Affiliation
Doctor in Family Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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Nutrition-dense Smoothie Diets Reduced Dysphagia Risk in the Elderly

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