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NCT Number: NCT07381881

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

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.

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Key information

Conditions

Dehydration Daily Fluid Intake Infections Metabolic Diseases Mortality Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Infections Respiratory Tract Diseases Respiratory Tract Infections Urinary Infections Water-Electrolyte Imbalance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lleida, 25005, Spain

Location contact

Dra. Teresa Rodríguez

CONTACT

[email protected]

+34973727222

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age equal to or greater than 65 years.

Exclusion criteria

  • No exclusion criteria have been established.

Treatment and study plan

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.

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.

Primary outcomes

  1. Daily fluid intake

    Time frame: From enrollment to the end of intervention at 12 months.

    Amount in millilitres (ml)

  2. Dehydration: Serum osmolality

    Time frame: Baseline and 3, 6 and 12 months

    [1,86*(Na+K)+1,15*Glucose+urea+14)] Risk dehydration ≥295 mOsm/kg Dehydration > 300mOsm/kg

  3. Dehydration: Blood Urea Nitrogen (BUN)

    Time frame: Baseline and 3, 6 and 12 months

    BUN = Urea/2.1428 Dehydration > 20mg/dl

  4. Number of urinary infections

    Time frame: Baseline and 3, 6 and 12 months.

    Data will be obtained through retrospective review of the clinical history

  5. Number of respiratory infections

    Time frame: Baseline and 3, 6 and 12 months.

    Data will be obtained through retrospective review of the clinical history.

  6. Mortality

    Time frame: Baseline and 3, 6 and 12 months.

    The number of people who will die during the study, as will be obtained from the clinical history.

Secondary outcomes

  1. Current Medical Conditions

    Time frame: Baseline and 3, 6 and 12 months.

    Medical conditions that the participant currently has.

  2. Pharmacological treatment

    Time frame: Baseline and 3, 6 and 12 months.

    Number of medications the participant takes per day and the type of each medication.

  3. Laboratory analyses

    Time frame: Baseline and 3, 6 and 12 months

    Blood biochemistry and urinalysis using Combur-Test®

  4. Efficacy and safety of swallowing

    Time frame: Baseline and 3, 6 and 12 months.

    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.

  5. Nutritional status

    Time frame: Baseline and 3, 6 and 12 months.

    Will be assessed using the Mini Nutritional Assessment (MNA). Scores range from 0 to 30. Malnutrition will be defined as scores < 17.

  6. Presence of lesions

    Time frame: Baseline and 3, 6 and 12 months.

    The number and location of lesions.

  7. Presence of edema

    Time frame: Baseline and 3, 6 and 12 months.

    Yes or no

  8. Dry skin

    Time frame: Baseline and 3, 6 and 12 months.

    Skin turgor: determining whether the skin remains elevated after being gently pinched and released.

  9. Cognitive status: Mini Cognitive Examination (MEC)

    Time frame: Baseline and 3, 6 and 12 months.

    Values = 0 - 30. Cognitive impairment: scores <= 23

  10. Cognitive status: Global Deterioration Scale (GDS)

    Time frame: Baseline and 3, 6 and 12 months.

    Values = 1 - 7. Dementia: scores ≥ 3

  11. Functional status

    Time frame: Baseline and 3, 6 and 12 months.

    Barthel index. Values = 0 - 100. Functional impairment: scores < 90

Other outcomes

  1. Birthdate

    Time frame: Baseline

    Date of birth in yyyy/mm/dd

  2. Sex

    Time frame: Baseline

    Female or male sex

  3. Marital status

    Time frame: Baseline

    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.

  4. Education level

    Time frame: Baseline

    Choose between no formal education, primary education, secondary education, or university education.

  5. Date of institutionalization

    Time frame: Baseline

    The date (yyyy/mm/dd) when the resident will be recorded as having begun institutionalization at the center.

Study contacts

Contact information is provided by the study sponsor or research team.

Dra. Teresa Botigué Satorra

CONTACT

[email protected]

+34 973702458

Sponsors and collaborators

Lead sponsor

Universitat de Lleida

Other

Collaborators

  • Hospital Universitari Santa Maria, Spain
  • Institut de Recerca Biomèdica de Lleida

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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