An interventional study of GEL-AID and Usual Care in Dehydration, Urinary Infections and Respiratory Infections, sponsored by Universitat de Lleida. Not yet recruiting at 1 site in Spain. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Universitat de Lleida · Not applicable, Interventional, and Prevention
The objective of this clinical trial is to assess whether hydration with gelled water (GEL-AID) can improve fluid intake and reduce cases of dehydration, as well as the incidence of urinary and respiratory infections in institutionalized elderly individuals in nursing homes.
The main question this trial aims to answer is:
Participants:
The control group will follow the center's usual hydration plan. Individuals with swallowing difficulties will receive thickened liquids and/or gelatin, while those without swallowing difficulties will be hydrated with unmodified liquids or gelatin.
The intervention group will receive hydration with GEL-AID. For participants with swallowing difficulties, thickened liquids and gelatin will be replaced by GEL-AID, with texture adapted to their needs. Those without swallowing difficulties will receive unmodified liquids and GEL-AID instead of gelatin.
201 studies on the registry are indexed under Dehydration; 28 are open to participants now.
This study's planned enrollment of 156 is above the median of 43 across 145 interventional studies indexed under Dehydration.
Browse Dehydration studies →Universitat de Lleida is the lead sponsor of 33 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The intervention group will receive hydration with GEL-AID.
Device: GEL-AID
The control group will follow the center's standard hydration plan.
Other: Usual Care
For patients with swallowing difficulties, thickened liquids with commercial thickeners and gelatin will be replaced with the GEL-AID product. The texture provided will depend on the results obtained from the Volume-Viscosity Swallow Test (V-VST). Those without swallowing difficulties will be hydrated with unmodified liquids and will also be offered GEL-AID as a replacement for gelatin.
Standard intervention. For subjects with swallowing difficulties, the hydration method will involve thickened liquids with a commercial thickener (texture adjusted according to the results obtained from the V-VST) and gelatin. Those without swallowing difficulties will be hydrated with unmodified liquids and will also be offered gelatin.
Daily fluid intake
Amount in millilitres (ml)
Time frame: From enrollment to the end of intervention at 12 months.
Dehydration: Serum osmolality
\[1,86\*(Na+K)+1,15\*Glucose+urea+14)\] Risk dehydration ≥295 mOsm/kg Dehydration \> 300mOsm/kg
Time frame: Baseline and 3, 6 and 12 months
Dehydration: Blood Urea Nitrogen (BUN)
BUN = Urea/2.1428 Dehydration \> 20mg/dl
Time frame: Baseline and 3, 6 and 12 months
Number of urinary infections
Data will be obtained through retrospective review of the clinical history
Time frame: Baseline and 3, 6 and 12 months.
Number of respiratory infections
Data will be obtained through retrospective review of the clinical history.
Time frame: Baseline and 3, 6 and 12 months.
Mortality
The number of people who will die during the study, as will be obtained from the clinical history.
Time frame: Baseline and 3, 6 and 12 months.
Current Medical Conditions
Medical conditions that the participant currently has.
Time frame: Baseline and 3, 6 and 12 months.
Pharmacological treatment
Number of medications the participant takes per day and the type of each medication.
Time frame: Baseline and 3, 6 and 12 months.
Laboratory analyses
Blood biochemistry and urinalysis using Combur-Test®
Time frame: Baseline and 3, 6 and 12 months
Efficacy and safety of swallowing
Volume-Viscosity Swallow Test (V-VST): identify clinical signs of impaired efficacy (labial seal impairment, oral and pharyngeal residue, and piecemeal deglutition) and impaired safety of swallowing (voice changes, coughing, and a decrease in oxygen saturation ≥3%). It begins with nectar viscosity and progressively increases the bolus volume, then proceeds to liquid, and finally to pudding viscosity.
Time frame: Baseline and 3, 6 and 12 months.
Nutritional status
Will be assessed using the Mini Nutritional Assessment (MNA). Scores range from 0 to 30. Malnutrition will be defined as scores \< 17.
Time frame: Baseline and 3, 6 and 12 months.
Presence of lesions
The number and location of lesions.
Time frame: Baseline and 3, 6 and 12 months.
Presence of edema
Yes or no
Time frame: Baseline and 3, 6 and 12 months.
Dry skin
Skin turgor: determining whether the skin remains elevated after being gently pinched and released.
Time frame: Baseline and 3, 6 and 12 months.
Cognitive status: Mini Cognitive Examination (MEC)
Values = 0 - 30. Cognitive impairment: scores \<= 23
Time frame: Baseline and 3, 6 and 12 months.
Cognitive status: Global Deterioration Scale (GDS)
Values = 1 - 7. Dementia: scores ≥ 3
Time frame: Baseline and 3, 6 and 12 months.
Functional status
Barthel index. Values = 0 - 100. Functional impairment: scores \< 90
Time frame: Baseline and 3, 6 and 12 months.
Birthdate
Date of birth in yyyy/mm/dd
Time frame: Baseline
Sex
Female or male sex
Time frame: Baseline
Marital status
The answer options are: single, married, in partnership (but not married), separated or divorced (currently without a partner), and wido. If the answer is "widowed," it must be specified whether the loss occurred less than one year ago or more than one year ago.
Time frame: Baseline
Education level
Choose between no formal education, primary education, secondary education, or university education.
Time frame: Baseline
Date of institutionalization
The date (yyyy/mm/dd) when the resident will be recorded as having begun institutionalization at the center.
Time frame: Baseline
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Feb 2027, 12 months later.
Of 65 non-industry interventional studies with no phase under Dehydration, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's planned 12 months is above that.
Counting every sponsor, half of 73 studies reached it within 9 months; a quarter within 5 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universitat de Lleida