Effect of a Sugar-free Isotonic Drink on Different Health Bioparameters

March 24, 2025 updated by: Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Alejandro Martínez Rodríguez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • men and women aged >18 years;
  • body mass index (BMI) of 18 to 25 kg/m^2;

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: CONTROL GROUP
Volunteer participants who will drink water
Other: PLACEBO
Intake of natural mineral water
Experimental: ISOTONIC DRINK GROUP
Volunteer participants who will drink Natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia.
Other: INTAKE OF ISOTONIC DRINK
Intake of natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks
Body composition
Time Frame: 12 weeks
Measurement of body composition using bioimpedance with the Biodyxpert device.
12 weeks
Body composition
Time Frame: 12 weeks
Measurement of body composition through anthropometry.
12 weeks
Blood pressure
Time Frame: 12 weeks
Measurement of systolic and diastolic blood pressure. Using an OMROM upper arm blood pressure monitor.
12 weeks
Perceived stress
Time Frame: 12 weeks
Measurement of perceived stress using the Perceived Stress Scale (PSS)
12 weeks
BLOOD GLUCOSE
Time Frame: 12 weeks
Glucose levels in blood by blood analysis.
12 weeks
BLOOD INSULIN
Time Frame: 12 weeks
Insulin levels in blood by blood analysis.
12 weeks
BLOOD LIPID PORFILE
Time Frame: 12 weeks
Cholesterol and triglycerides levels in blood.
12 weeks
Specific color of urine
Time Frame: 12 weeks
12 weeks
Specific gravity of urine
Time Frame: 12 weeks
12 weeks
Minerals in urine
Time Frame: 12 weeks
K+ (Potassium), Na+ (Sodium), Mg2+ (Magnesium), Ca2+ (Calcium)
12 weeks
Urinary pH
Time Frame: 12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
Sleep quality
Time Frame: 12 weeks
Measurement of sleep quality using the Pittsburgh sleep quality index.
12 weeks
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
12 weeks
Microbiome Indices
Time Frame: 12 weeks
Microbiome indices through stool sample; Firmicutes/Bacteroidetes, Bacteroides/Prevotella, Enterobacteria/Enterococcus, Clostridium coccoides/perfringens
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 12 weeks
Weight evaluation using a digital scale
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alicante

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UA-2023-10-03

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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