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

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: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: PLACEBO; Other: INTAKE OF ISOTONIC DRINK

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
Body composition	Measurement of body composition using bioimpedance with the Biodyxpert device.	12 weeks
Body composition	Measurement of body composition through anthropometry.	12 weeks
Blood pressure	Measurement of systolic and diastolic blood pressure. Using an OMROM upper arm blood pressure monitor.	12 weeks
Perceived stress	Measurement of perceived stress using the Perceived Stress Scale (PSS)	12 weeks
BLOOD GLUCOSE	Glucose levels in blood by blood analysis.	12 weeks
BLOOD INSULIN	Insulin levels in blood by blood analysis.	12 weeks
BLOOD LIPID PORFILE	Cholesterol and triglycerides levels in blood.	12 weeks
Specific color of urine		12 weeks
Specific gravity of urine		12 weeks
Minerals in urine	K+ (Potassium), Na+ (Sodium), Mg2+ (Magnesium), Ca2+ (Calcium)	12 weeks
Urinary pH		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.	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.	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.	12 weeks
Sleep quality	Measurement of sleep quality using the Pittsburgh sleep quality index.	12 weeks
Liver biomarkers	Measurement of liver biomarkers through a blood test; Aspartate aminotransferase (AST or GOT), Alanine aminotransferase (ALT or GPT) and Bilirubin	12 weeks
Microbiome Indices	Microbiome indices through stool sample; Firmicutes/Bacteroidetes, Bacteroides/Prevotella, Enterobacteria/Enterococcus, Clostridium coccoides/perfringens	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight evaluation using a digital scale	12 weeks

Collaborators and Investigators

• Sponsor: University of Alicante

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID 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