GEL-AID: Safe and Effective Hydration for Institutionalized Older Adults

Efficacy and Efficiency of GEL-AID Gelled Water for Hydration in Institutionalized Older People

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:

• Do institutionalized elderly individuals hydrated with GEL-AID increase their daily fluid intake and reduce the incidence of dehydration, urinary infections, and respiratory infections?

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mortality; Dehydration; Respiratory Infections; Urinary Infections; Daily Fluid Intake
• Intervention / Treatment: Device: GEL-AID; Other: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dra. Teresa Botigué Satorra; Phone Number: +34 973702458; Email: teresa.botigue@udl.cat

Study Locations

• Spain
  • Lleida
    • Lleida, Lleida, Spain, 25005
      • Residència per a la Gent Gran Lleida-Balàfia i Residència i Centre de Dia per a la Gent Gran Balàfia II
      • Contact: Dra. Teresa Rodríguez; Phone Number: +34973727222; Email: trodriguez@gss.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age equal to or greater than 65 years.

Exclusion Criteria:

• No exclusion criteria have been established.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group will receive hydration with GEL-AID.	Device: GEL-AID; 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.
Active Comparator: Control Group; The control group will follow the center's standard hydration plan.	Other: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily fluid intake	Amount in millilitres (ml)	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	Baseline and 3, 6 and 12 months
Dehydration: Blood Urea Nitrogen (BUN)	BUN = Urea/2.1428 Dehydration > 20mg/dl	Baseline and 3, 6 and 12 months
Number of urinary infections	Data will be obtained through retrospective review of the clinical history	Baseline and 3, 6 and 12 months.
Number of respiratory infections	Data will be obtained through retrospective review of the clinical history.	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.	Baseline and 3, 6 and 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current Medical Conditions	Medical conditions that the participant currently has.	Baseline and 3, 6 and 12 months.
Pharmacological treatment	Number of medications the participant takes per day and the type of each medication.	Baseline and 3, 6 and 12 months.
Laboratory analyses	Blood biochemistry and urinalysis using Combur-Test®	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.	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.	Baseline and 3, 6 and 12 months.
Presence of lesions	The number and location of lesions.	Baseline and 3, 6 and 12 months.
Presence of edema	Yes or no	Baseline and 3, 6 and 12 months.
Dry skin	Skin turgor: determining whether the skin remains elevated after being gently pinched and released.	Baseline and 3, 6 and 12 months.
Cognitive status: Mini Cognitive Examination (MEC)	Values = 0 - 30. Cognitive impairment: scores <= 23	Baseline and 3, 6 and 12 months.
Cognitive status: Global Deterioration Scale (GDS)	Values = 1 - 7. Dementia: scores ≥ 3	Baseline and 3, 6 and 12 months.
Functional status	Barthel index. Values = 0 - 100. Functional impairment: scores < 90	Baseline and 3, 6 and 12 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex	Female or male sex	Baseline
Birthdate	Date of birth in yyyy/mm/dd	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.	Baseline
Education level	Choose between no formal education, primary education, secondary education, or university education.	Baseline
Date of institutionalization	The date (yyyy/mm/dd) when the resident will be recorded as having begun institutionalization at the center.	Baseline

Collaborators and Investigators

• Sponsor: Universitat de Lleida
• Collaborators: Institut de Recerca Biomèdica de Lleida; Hospital Universitari de Santa María (Lleida - Spain).

Study record dates

Study Major Dates

• Study Start (Estimated): February 23, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: aged; dehydration; nursing homes; fluid intake; gelled water
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Infections; Respiratory Tract Diseases; Water-Electrolyte Imbalance; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Dehydration; Respiratory Tract Infections
• Other Study ID Numbers: PI24/00413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No