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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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04901182
Study type Interventional
Source Mahidol University
Contact
Status Completed
Phase N/A
Start date January 8, 2019
Completion date April 30, 2019

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