Clinical trial NCT04901182: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: aging
smoothie drink
dysphagia
swallowing capacity
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 63
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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:

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

Primary outcomes:
measure: Level of severity of dysphagia as assessed by a healthcare professional using the FEES
timeFrame: Baseline
Secondary outcomes:
measure: Premature spillage of material as assessed by a healthcare professional using the FEES
timeFrame: Baseline
measure: Retention/pooling of material and/or secretion as assessed by a healthcare professional using the FEES
timeFrame: Baseline
measure: 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
timeFrame: Baseline
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Doctor in Family Medicine
name: Korapat Mayurasakorn, MD.
role: PRINCIPAL_INVESTIGATOR
References: