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Completed

NCT Number: NCT06184997

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alejandro Martínez Rodríguez

Elche, Alicante, 03203, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INTAKE OF ISOTONIC DRINK

Other

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

Placebo

Other

Intake of natural mineral water

Primary outcomes

  1. Body composition

    Time frame: 12 weeks

    Measurement of body composition using bioimpedance with the Biodyxpert device.

  2. Body composition

    Time frame: 12 weeks

    Measurement of body composition through anthropometry.

  3. Blood pressure

    Time frame: 12 weeks

    Measurement of systolic and diastolic blood pressure. Using an OMROM upper arm blood pressure monitor.

  4. 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.

  5. Perceived stress

    Time frame: 12 weeks

    Measurement of perceived stress using the Perceived Stress Scale (PSS)

  6. BLOOD GLUCOSE

    Time frame: 12 weeks

    Glucose levels in blood by blood analysis.

  7. BLOOD INSULIN

    Time frame: 12 weeks

    Insulin levels in blood by blood analysis.

  8. BLOOD LIPID PORFILE

    Time frame: 12 weeks

    Cholesterol and triglycerides levels in blood.

  9. Specific color of urine

    Time frame: 12 weeks

  10. Specific gravity of urine

    Time frame: 12 weeks

  11. Minerals in urine

    Time frame: 12 weeks

    K+ (Potassium), Na+ (Sodium), Mg2+ (Magnesium), Ca2+ (Calcium)

  12. Urinary pH

    Time frame: 12 weeks

  13. 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.

  14. 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.

  15. 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.

  16. Sleep quality

    Time frame: 12 weeks

    Measurement of sleep quality using the Pittsburgh sleep quality index.

  17. 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

  18. Microbiome Indices

    Time frame: 12 weeks

    Microbiome indices through stool sample; Firmicutes/Bacteroidetes, Bacteroides/Prevotella, Enterobacteria/Enterococcus, Clostridium coccoides/perfringens

Secondary outcomes

  1. Weight

    Time frame: 12 weeks

    Weight evaluation using a digital scale

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 29, 2023
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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