DehydrationNCT07381881
GEL-AID: Safe and Effective Hydration for Institutionalized Older Adults
A study testing GEL-AID in people with Dehydration and Urinary Infections, run by Universitat de Lleida at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Urinary Infections, Respiratory Infections
- What is being tested?
- GEL-AID
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- 23 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age equal to or greater than 65 years.
Who cannot join
- No exclusion criteria have been established.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Residència per a la Gent Gran Lleida-Balàfia i Residència i Centre de Dia per a la Gent Gran Balàfia II
Lleida, Lleida, 25005
Dra. Teresa Rodríguez, +34973727222, trodriguez@gss.cat
About this study
Official title: 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:
Read more
- 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.
- Being tested
- GEL-AID, Usual Care
- Keywords
- dehydration, aged, nursing homes, fluid intake, gelled water
- Medical subject headings
- Dehydration, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEL-AIDDevice
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive hydration with GEL-AID. Receives: Device: GEL-AID |
| Control Group | Active comparator | The control group will follow the center's standard hydration plan. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily fluid intake
Amount in millilitres (ml)
Measured: 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
Measured: Baseline and 3, 6 and 12 months
Dehydration: Blood Urea Nitrogen (BUN)
BUN = Urea/2.1428 Dehydration > 20mg/dl
Measured: Baseline and 3, 6 and 12 months
Number of urinary infections
Data will be obtained through retrospective review of the clinical history
Measured: Baseline and 3, 6 and 12 months.
Number of respiratory infections
Data will be obtained through retrospective review of the clinical history.
Measured: 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.
Measured: Baseline and 3, 6 and 12 months.
Secondary outcomes (11)
Current Medical Conditions
Medical conditions that the participant currently has.
Measured: Baseline and 3, 6 and 12 months.
Pharmacological treatment
Number of medications the participant takes per day and the type of each medication.
Measured: Baseline and 3, 6 and 12 months.
Laboratory analyses
Blood biochemistry and urinalysis using Combur-Test®
Measured: 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.
Measured: 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.
Measured: Baseline and 3, 6 and 12 months.
Presence of lesions
The number and location of lesions.
Measured: Baseline and 3, 6 and 12 months.
Presence of edema
Yes or no
Measured: Baseline and 3, 6 and 12 months.
Dry skin
Skin turgor: determining whether the skin remains elevated after being gently pinched and released.
Measured: Baseline and 3, 6 and 12 months.
Cognitive status: Mini Cognitive Examination (MEC)
Values = 0 - 30. Cognitive impairment: scores <= 23
Measured: Baseline and 3, 6 and 12 months.
Cognitive status: Global Deterioration Scale (GDS)
Values = 1 - 7. Dementia: scores ≥ 3
Measured: Baseline and 3, 6 and 12 months.
Functional status
Barthel index. Values = 0 - 100. Functional impairment: scores < 90
Measured: Baseline and 3, 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start23 Feb 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recerca Biomèdica de Lleida, Hospital Universitari Santa Maria, Spain
- Responsible party
- Principal investigator, Teresa Botigué Satorra, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381881
- Sponsor's protocol ID
- PI24/00413
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Efficiency of GEL-AID Gelled Water for Hydration in Institutionalized Older People
- ClinicalTrials.gov ID
- NCT07381881
- Acronym / sponsor ID
- PI24/00413
- Keywords
- dehydration, aged, nursing homes, fluid intake, gelled water
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Collaborators
- Institut de Recerca Biomèdica de Lleida, Hospital Universitari Santa Maria, Spain
- Study start
- 23 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: GEL-AIDThe intervention group will receive hydration with GEL-AID. |
| Control Group | Active comparator | Other: Usual CareThe control group will follow the center's standard hydration plan. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age equal to or greater than 65 years.
Key exclusion criteria (1 listed)
- No exclusion criteria have been established.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEL-AIDFor 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. | Device | Intervention group |
| Usual CareStandard 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. | Other | Control Group |
Primary outcome
Daily fluid intake
Time frame: From enrollment to the end of intervention at 12 months.
Amount in millilitres (ml)
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
Dehydration: Blood Urea Nitrogen (BUN)
Time frame: Baseline and 3, 6 and 12 months
BUN = Urea/2.1428 Dehydration > 20mg/dl
Number of urinary infections
Time frame: Baseline and 3, 6 and 12 months.
Data will be obtained through retrospective review of the clinical history
Number of respiratory infections
Time frame: Baseline and 3, 6 and 12 months.
Data will be obtained through retrospective review of the clinical history.
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.
11 secondary outcomes
Current Medical Conditions
Time frame: Baseline and 3, 6 and 12 months.
Pharmacological treatment
Time frame: Baseline and 3, 6 and 12 months.
Laboratory analyses
Time frame: Baseline and 3, 6 and 12 months
Efficacy and safety of swallowing
Time frame: Baseline and 3, 6 and 12 months.
Nutritional status
Time frame: Baseline and 3, 6 and 12 months.
Presence of lesions
Time frame: Baseline and 3, 6 and 12 months.
Presence of edema
Time frame: Baseline and 3, 6 and 12 months.
Dry skin
Time frame: Baseline and 3, 6 and 12 months.
Cognitive status: Mini Cognitive Examination (MEC)
Time frame: Baseline and 3, 6 and 12 months.
Cognitive status: Global Deterioration Scale (GDS)
Time frame: Baseline and 3, 6 and 12 months.
Functional status
Time frame: Baseline and 3, 6 and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GEL-AID in people with Dehydration and Urinary Infections, run by Universitat de Lleida at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dra. Teresa Botigué Satorra (+34 973702458, teresa.botigue@udl.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily fluid intake (time frame: From enrollment to the end of intervention at 12 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.