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Completed

NCT Number: NCT04901182

Nutrition-dense Smoothie Diets Reduced Dysphagia Risk in the Elderly

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Level of severity of dysphagia as assessed by a healthcare professional using the FEES

    Time frame: Baseline

    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 outcomes

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

    Time frame: Baseline

    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

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

    Time frame: Baseline

    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

  3. 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

    Time frame: Baseline

    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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 25, 2021
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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