Table 5.

Overview of study outcomes, instruments, and assessment details

	Outcome	Instruments	Score	Assessment details
Primary	Body Weight	Calibrated lift with integrated scale, mobile chair with integrated scale or wheelchair platform with integrated scale	Body weight weighed to the nearest gram	The resident is in fasting state and preferably dressed in light clothing and without shoes
Secondary	Nutritional intake	Standardized three-day food diary and a kitchen scale	Food products weighed to the nearest gram	Food products, leftovers and napkins with spit out food pieces will be weighed by a member of the trained study team
	HRQoL and OD-specific QoL	Standardized questionnaire EQ-5D-5L [33] and VAS: EQ VAS, DSS, DHRQoL [34, 35] and DAS	EQ-5D descriptive system [no problems/slight problems/moderate problems/severe problems/extreme problems] EQ VAS [0–100 score], DSS [0–10 score], DHRQoL [0–10 score], DAS [0–10 score]	Self-assessment or proxy-assessment
	Compliance to test product	Standardized compliance log	Amount of product leftover [no leftover/quarter/half/three quarters/complete leftover]	Filled out by nursing staff
Exploratory	ADL	Validated Barthel Index (BI) [36]	0 [dependent] - 20 [independent]	Conducted by a member of the trained study team
	Activity	Activity monitor activPAL3™ (PAL Technologies Ltd., Glasgow, UK) [37, 38] with activity log	Steps [count], upright/sitting/lying position [hours], stepping/standing position [hours]	Applied and completed by a member of the trained study team
	Anthropometrics	Measuring tape	Upper-arm and calf-circumference [cm]	Conducted by a member of the trained study team
	Blood nutritional- and hydration parameters	Laboratory analysis	Osmolality [mOsmol/kg], sodium [mmol/L], vitamin D [nmol/L], vitamin B12 [pmol/L], folate [nmol/L], magnesium [mmol/L], albumin (g/L) and calcium [mmol/L]	Clinical chemical and hematological laboratory of the Zuyderland Hospital (Heerlen-Sittard, the Netherlands)
	Vital signs	Electronic blood pressure monitor	Heart rate [bpm] and systolic and diastolic blood pressure [mmHg]	Conducted by a member of the trained study team
	Oxygen saturation	Oximeter	Oxygen saturation level [%]	Conducted by a member of the trained study team
	Dysphagia severity: swallowing assessment	3-oz WST [26], swallow observation, water thickness test, Modified version of the MISA [27]	Swallow of 3 oz water [positive/negative], descriptive report summary of swallow observation, safest thickness level of liquids for swallowing, completed modified MISA	Conducted by the trained SLT More details in Table 3
	Palatability of the test product	Standardized questionnaire	Taste [1 (poor taste) - 10 (very tasty)], viscosity [too thick/good/too thin], sweetness [too sweet/good/not sweet enough] and swallowing ability [1 (very difficult) - 10 (very easy)]	Self-assessment
Safety	(S)AEs	(S) AE forms	MedDRA Medical Coding	Coding will be done by the data manager

Abbreviations: EuroQol 5-dimensions 5-level (EQ-5D-5L), Visual Analog Scale (VAS), EUROQoL-VAS (EQ-VAS), Dysphagia Severity Scale (DSS), Dysphagia HRQoL (DHRQoL), Dysphagia-related Anxiety Scale (DAS), 3 oz Water Swallow Test (3-oz WST), McGill Ingestive Skills Assessment (MISA), (Serious) Adverse Event ((S)AE)