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

Study Overview
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: INTAKE OF ISOTONIC DRINK
* Other: PLACEBO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women aged &amp;gt;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&amp;#39;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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CONTROL GROUP<br>Volunteer participants who will drink water | Other: PLACEBO<br>* Intake of natural mineral water<br>|
| Experimental: ISOTONIC DRINK GROUP<br>Volunteer participants who will drink Natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia. | Other: INTAKE OF ISOTONIC DRINK<br>* Intake of natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |