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