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

NCT ID: NCT06184997

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-08

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants will not be aware that there are other people consuming a different type of drink than theirs. The person analyzing the results will also be unaware. However, the researchers will be aware because they need to control the supply.

Study Groups

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CONTROL GROUP

Volunteer participants who will drink water

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type OTHER

Intake of natural mineral water

ISOTONIC DRINK GROUP

Volunteer participants who will drink Natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia.

Group Type EXPERIMENTAL

INTAKE OF ISOTONIC DRINK

Intervention Type OTHER

Intake of natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia.

Interventions

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INTAKE OF ISOTONIC DRINK

Intake of natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia.

Intervention Type OTHER

PLACEBO

Intake of natural mineral water

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alicante

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Alejandro Martínez-Rodríguez

Full professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alejandro Martínez Rodríguez

Elche, Alicante, Spain

Site Status

Countries

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Spain

Other Identifiers

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UA-2023-10-03

Identifier Type: -

Identifier Source: org_study_id

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