Nutrition-dense Smoothie Diets Reduced Dysphagia Risk in the Elderly

Dysphagia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901182
• Other study ID #: 460/2560(EC3)
• Status: Completed
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 elderly people with dysphagia risk.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Diagnostic Test:
• 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)

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline
Secondary	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	Baseline
Secondary	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	Baseline