Healthy VolunteersNCT06184997
Effect of a Sugar-free Isotonic Drink on Different Health Bioparameters
A study testing INTAKE OF ISOTONIC DRINK in people with Healthy Volunteers, run by University of Alicante at 1 site in Spain.
Trial summary
Randomized clinical trial in which 160 participants (80 men, 80 women) will be assigned to one of two groups (40 participants per group), to determine the effects of isotonic drink on different health parameters, following published recommendations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- INTAKE OF ISOTONIC DRINK
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women aged \>18 years;
- body mass index (BMI) of 18 to 25 kg/m^2;
Who cannot join
- individuals who have taken medication up to 3 months before the start of the study or supplements during the study;
- individuals with a history of gastrointestinal pathology or disorder such as duodenal ulcer, chronic colitis, or chronic inflammatory disease/surgery of the gastrointestinal tract (Crohn\'s disease, ulcerative colitis), celiac disease, or irritable bowel syndrome;
- individuals with serious acute or chronic diseases, treatments, or recent surgery;
- individuals with a report of serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) above the upper limit of the reference interval.
Trial locations and contacts
1 site in 1 country.
About this study
Randomized clinical trial in which 160 participants (80 men, 80 women) will be assigned to one of two groups (40 participants per group), to determine the effects of isotonic drink on different health parameters, following published recommendations. Subjects will be electronically randomized by block design into two arms: an experimental group: isotonic drink and a control group (placebo): normal water.
- Conditions
- Healthy Volunteers
- Being tested
- INTAKE OF ISOTONIC DRINK, PLACEBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTAKE OF ISOTONIC DRINKOther
Intake of natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia.
PLACEBOOther
Intake of natural mineral water
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | Placebo comparator | Volunteer participants who will drink water Receives: Other: PLACEBO |
| ISOTONIC DRINK GROUP | Experimental | Volunteer participants who will drink Natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia. Receives: Other: INTAKE OF ISOTONIC DRINK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Measurement of body composition using bioimpedance with the Biodyxpert device.
Measured: 12 weeks
Body composition
Measurement of body composition through anthropometry.
Measured: 12 weeks
Blood pressure
Measurement of systolic and diastolic blood pressure. Using an OMROM upper arm blood pressure monitor.
Measured: 12 weeks
Perception of quality of life
Using a Quality of Life Questionnaire (SF36). Quality of Life Questionnaire is a comprehensive questionnaire that covers various attributes of an individuals life. It covers a variety of demographic questions to get better quality data and information before analyzing the quality of life of an individual.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: 12 weeks
Perceived stress
Measurement of perceived stress using the Perceived Stress Scale (PSS)
Measured: 12 weeks
BLOOD GLUCOSE
Glucose levels in blood by blood analysis.
Measured: 12 weeks
BLOOD INSULIN
Insulin levels in blood by blood analysis.
Measured: 12 weeks
BLOOD LIPID PORFILE
Cholesterol and triglycerides levels in blood.
Measured: 12 weeks
Specific color of urine
Measured: 12 weeks
Specific gravity of urine
Measured: 12 weeks
Minerals in urine
K+ (Potassium), Na+ (Sodium), Mg2+ (Magnesium), Ca2+ (Calcium)
Measured: 12 weeks
Urinary pH
Measured: 12 weeks
Mood States Profile
The POMS (Profile of Mood States) questionnaire is a psychological assessment tool widely used to measure mood states. It consists of a series of words or phrases that describe feelings and emotions. Participants are asked to rate each item on a scale, indicating how well it represents their mood over a specific period. The POMS measures six different mood dimensions: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. It's commonly used in clinical settings, as well as in research studies, to assess the impact of various treatments or interventions on mood states. The POMS is valued for its sensitivity in detecting mood changes over time and its ability to differentiate between various mood states.
Measured: 12 weeks
Evaluation of constipation symptoms by the patient
The PAC-SYM (Patient Assessment of Constipation Symptoms) is a self-report questionnaire designed to evaluate the symptoms of constipation from the patient's perspective. It is commonly used in clinical research and practice to assess the severity and impact of constipation symptoms. The questionnaire includes a series of items that ask patients to rate the frequency and severity of their constipation-related symptoms, such as abdominal discomfort, straining, and incomplete bowel movements.
Measured: 12 weeks
Evaluation of the quality of life of patients with constipation (PAC-QOL)
The PAC-QOL (Patient Assessment of Constipation Quality of Life) questionnaire is a specialized tool designed to assess the quality of life in individuals suffering from constipation. It is a patient-reported outcome measure that focuses on how constipation affects a person's daily life, well-being, and overall health.
Measured: 12 weeks
Sleep quality
Measurement of sleep quality using the Pittsburgh sleep quality index.
Measured: 12 weeks
Liver biomarkers
Measurement of liver biomarkers through a blood test; Aspartate aminotransferase (AST or GOT), Alanine aminotransferase (ALT or GPT) and Bilirubin
Measured: 12 weeks
Microbiome Indices
Microbiome indices through stool sample; Firmicutes/Bacteroidetes, Bacteroides/Prevotella, Enterobacteria/Enterococcus, Clostridium coccoides/perfringens
Measured: 12 weeks
Secondary outcomes (1)
Weight
Weight evaluation using a digital scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start8 Jan 2024
- Primary completion1 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to group A (water, placebo) or group B (sugar-free isotonic drink), and will be instructed to consume 265 ml of water or 265 ml of sugar-free isotonic drink, respectively, every day for 12 weeks. During the study period, participants will be advised to maintain their usual diet and physical activity.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184997
- Sponsor's protocol ID
- UA-2023-10-03
- Status last verified
- Mar 2025
- First submitted
- 14 Dec 2023
- Last updated
- 25 Mar 2025
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Sugar-free Isotonic Drink on Different Health Bioparameters
- ClinicalTrials.gov ID
- NCT06184997
- Acronym / sponsor ID
- UA-2023-10-03
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 29 Dec 2023 (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.
Randomized clinical trial in which 160 participants (80 men, 80 women) will be assigned to one of two groups (40 participants per group), to determine the effects of isotonic drink on different health parameters, following published recommendations. Subjects will be electronically randomized by block design into two arms: an experimental group: isotonic drink and a control group (placebo): normal water.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to group A (water, placebo) or group B (sugar-free isotonic drink), and will be instructed to consume 265 ml of water or 265 ml of sugar-free isotonic drink, respectively, every day for 12 weeks. During the study period, participants will be advised to maintain their usual diet and physical activity.
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | Placebo comparator | Other: PLACEBOVolunteer participants who will drink water |
| ISOTONIC DRINK GROUP | Experimental | Other: INTAKE OF ISOTONIC DRINKVolunteer participants who will drink Natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- men and women aged \>18 years;
- body mass index (BMI) of 18 to 25 kg/m^2;
Key exclusion criteria (4 listed)
- individuals who have taken medication up to 3 months before the start of the study or supplements during the study;
- individuals with a history of gastrointestinal pathology or disorder such as duodenal ulcer, chronic colitis, or chronic inflammatory disease/surgery of the gastrointestinal tract (Crohn\'s disease, ulcerative colitis), celiac disease, or irritable bowel syndrome;
- individuals with serious acute or chronic diseases, treatments, or recent surgery;
- individuals with a report of serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) above the upper limit of the reference interval.
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 |
|---|---|---|
| INTAKE OF ISOTONIC DRINKIntake of natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia. | Other | ISOTONIC DRINK GROUP |
| PLACEBOIntake of natural mineral water | Other | CONTROL GROUP |
Primary outcome
Body composition
Time frame: 12 weeks
Measurement of body composition using bioimpedance with the Biodyxpert device.
Body composition
Time frame: 12 weeks
Measurement of body composition through anthropometry.
Blood pressure
Time frame: 12 weeks
Measurement of systolic and diastolic blood pressure. Using an OMROM upper arm blood pressure monitor.
Perception of quality of life
Time frame: 12 weeks
Using a Quality of Life Questionnaire (SF36). Quality of Life Questionnaire is a comprehensive questionnaire that covers various attributes of an individuals life. It covers a variety of demographic questions to get better quality data and information before analyzing the quality of life of an individual.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Perceived stress
Time frame: 12 weeks
Measurement of perceived stress using the Perceived Stress Scale (PSS)
BLOOD GLUCOSE
Time frame: 12 weeks
Glucose levels in blood by blood analysis.
BLOOD INSULIN
Time frame: 12 weeks
Insulin levels in blood by blood analysis.
BLOOD LIPID PORFILE
Time frame: 12 weeks
Cholesterol and triglycerides levels in blood.
Specific color of urine
Time frame: 12 weeks
Specific gravity of urine
Time frame: 12 weeks
Minerals in urine
Time frame: 12 weeks
K+ (Potassium), Na+ (Sodium), Mg2+ (Magnesium), Ca2+ (Calcium)
Urinary pH
Time frame: 12 weeks
Mood States Profile
Time frame: 12 weeks
The POMS (Profile of Mood States) questionnaire is a psychological assessment tool widely used to measure mood states. It consists of a series of words or phrases that describe feelings and emotions. Participants are asked to rate each item on a scale, indicating how well it represents their mood over a specific period. The POMS measures six different mood dimensions: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. It's commonly used in clinical settings, as well as in research studies, to assess the impact of various treatments or interventions on mood states. The POMS is valued for its sensitivity in detecting mood changes over time and its ability to differentiate between various mood states.
Evaluation of constipation symptoms by the patient
Time frame: 12 weeks
The PAC-SYM (Patient Assessment of Constipation Symptoms) is a self-report questionnaire designed to evaluate the symptoms of constipation from the patient's perspective. It is commonly used in clinical research and practice to assess the severity and impact of constipation symptoms. The questionnaire includes a series of items that ask patients to rate the frequency and severity of their constipation-related symptoms, such as abdominal discomfort, straining, and incomplete bowel movements.
Evaluation of the quality of life of patients with constipation (PAC-QOL)
Time frame: 12 weeks
The PAC-QOL (Patient Assessment of Constipation Quality of Life) questionnaire is a specialized tool designed to assess the quality of life in individuals suffering from constipation. It is a patient-reported outcome measure that focuses on how constipation affects a person's daily life, well-being, and overall health.
Sleep quality
Time frame: 12 weeks
Measurement of sleep quality using the Pittsburgh sleep quality index.
Liver biomarkers
Time frame: 12 weeks
Measurement of liver biomarkers through a blood test; Aspartate aminotransferase (AST or GOT), Alanine aminotransferase (ALT or GPT) and Bilirubin
Microbiome Indices
Time frame: 12 weeks
Microbiome indices through stool sample; Firmicutes/Bacteroidetes, Bacteroides/Prevotella, Enterobacteria/Enterococcus, Clostridium coccoides/perfringens
1 secondary outcome
Weight
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTAKE OF ISOTONIC DRINK in people with Healthy Volunteers, run by University of Alicante 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 25 Mar 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: 12 weeks). The study lists 18 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 25 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.