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

University of Alicante

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: INTAKE OF ISOTONIC DRINK; Other: PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT06184997

UA-2023-10-03

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups, including a placebo group

CONTROL GROUP

Placebo Comparator group

Description:

Volunteer participants who will drink water

Treatment:

Other: PLACEBO

ISOTONIC DRINK GROUP

Experimental group

Description:

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

Treatment:

Other: INTAKE OF ISOTONIC DRINK