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

NCT07381881 | Not Yet Recruiting

• 1 other identifier: PI24/00413
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dehydration; Urinary Infections; Respiratory Infections; Daily Fluid Intake; Mortality

Keywords

dehydration; aged; nursing homes; fluid intake; gelled water

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (11)

• Current Medical Conditions

  Baseline and 3, 6 and 12 months.

• Pharmacological treatment

  Baseline and 3, 6 and 12 months.

• Laboratory analyses

  Baseline and 3, 6 and 12 months

• Efficacy and safety of swallowing

  Baseline and 3, 6 and 12 months.

• Nutritional status

  Baseline and 3, 6 and 12 months.

Other Outcomes (5)

• Birthdate

  Baseline

• Sex

  Baseline

• Marital status

  Baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive hydration with GEL-AID.

Device: GEL-AID

Control Group

ACTIVE COMPARATOR

The control group will follow the center's standard hydration plan.

Other: Usual Care

Interventions

GEL-AID DEVICE

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.

Intervention group

Usual Care OTHER

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.

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age equal to or greater than 65 years.

Sponsors & Collaborators

• Universitat de Lleida: lead
• Institut de Recerca Biomèdica de Lleida: collaborator
• Hospital Universitari de Santa María (Lleida - Spain).: collaborator

Study Sites (1)

Residència per a la Gent Gran Lleida-Balàfia i Residència i Centre de Dia per a la Gent Gran Balàfia II

Lleida, Lleida, 25005, Spain

Location

MeSH Terms

Conditions

Dehydration; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Respiratory Tract Diseases

Central Study Contacts

Dra. Teresa Botigué Satorra

CONTACT

+34 973702458; teresa.botigue@udl.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Health

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 2, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)